Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03499808
Other study ID # S1702
Secondary ID NCI-2017-01375S1
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date June 6, 2018
Est. completion date July 31, 2025

Study information

Verified date January 2024
Source SWOG Cancer Research Network
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial studies how well isatuximab works in treating patients with primary amyloidosis that has come back or does not respond to treatment. Monoclonal antibodies, such as isatuximab, may interfere with the ability of cancer cells to grow and spread.


Description:

PRIMARY OBJECTIVES: I. To assess the efficacy as measured by the confirmed overall hematologic response rate (partial response or better) of isatuximab in relapsed/refractory systemic light chain (AL) amyloidosis. SECONDARY OBJECTIVES: I. To evaluate toxicities in the treatment of relapsed/refractory AL amyloidosis with isatuximab. II. To evaluate time to hematologic response. III. To evaluate duration of response. IV. To evaluate progression-free survival (PFS). V. To evaluate overall survival (OS). TERTIARY OBJECTIVES: I. To evaluate efficacy of isatuximab in relapsed/refractory immunoglobulin amyloid light chain (AL) amyloidosis as measured by organ specific response rates (cardiac, renal, gastrointestinal [GI], liver, soft tissue, nerve), in the subset of patients that can be evaluated for organ response. II. To evaluate time to organ response in the subset of patients that can be evaluated for organ response. OUTLINE: Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up within 30 days and then every at least every 6 months for up to 4 years.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 43
Est. completion date July 31, 2025
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient must have relapsed or refractory primary systemic AL amyloidosis, histologically-confirmed by positive Congo red stain with green by birefringence on polarized light microscopy, OR characteristic appearance by electron microscopy AND confirmatory AL amyloid typing (mass spectrometry-based proteomic analysis or immunofluorescence) - Patient must have measurable disease within 28 days prior to registration; serum beta2 microglobulin, serum quantitative immunoglobulins (immunoglobulin [Ig]G, IgA, and IgM), serum free kappa and lambda, and serum protein electrophoresis (SPEP) with M-protein quantification must be obtained within 14 days prior to registration - Patient must demonstrate a difference in the involved serum free light chains (kappa or lambda) versus the uninvolved serum free light chain of >= 4.5 mg/dL within 14 days prior to registration - Patient must have objective organ involvement defined by ONE (or more) of the following; all disease for involved organs must be assessed and documented on the AL baseline tumor assessment form - Kidney: albuminuria greater than or equal to 500 mg per day on a 24-hour urine specimen within 35 days prior to registration, OR prior kidney biopsy (at time of diagnosis) showing amyloid deposition - Heart: mean left ventricular wall thickness on echocardiogram greater than or equal to 12 mm in the absence of hypertension or valvular heart disease, OR N-terminal fragment brain natriuretic protein (NT-pro) brain natriuretic peptide (BNP) greater than 332 ng/mL provided that patient does not have impaired renal function (as defined by calculated creatinine clearance less than 25 mL/min) within 14 days prior to registration, OR prior cardiac biopsy (at time of diagnosis) showing amyloid deposition with past documented or presently noted clinical symptoms and signs supportive of a diagnosis of heart failure in the absence of an alternative explanation for heart failure - Liver: hepatomegaly (total liver span > 15 cm) as demonstrated by computed tomography (CT) or magnetic resonance imaging (MRI) within 35 days prior to registration OR elevated alkaline phosphatase (ALP) greater than 1.5 times the upper limit of normal within 14 days prior to registration, OR prior liver biopsy (at time of diagnosis) showing amyloid deposition - Gastrointestinal tract: prior biopsy showing amyloid deposition AND symptoms such as GI bleeding or persistent diarrhea (> 4 loose stools/day on most days over a consecutive 28-day period) - Autonomic or peripheral nervous system: orthostatic blood pressure, symptoms of nausea, early satiety, diarrhea or constipation, abnormal sensory and/or motor findings on neurologic exam, or gastric atony by gastric emptying scan; Note: pulse and blood pressure must be recorded with the patient supine (lying down), and then again after at least 1 minute, but less than 3 minutes of standing; this assessment must be repeated on 2 separate occasions (at least 1 day apart; e.g. day -3 and day -1) within a 28-day screening period - Soft tissue: macroglossia, or soft tissue deposits (including lymphadenopathy, recurrent peri-orbital purpura, peri-articular, skin or other soft tissue) requiring therapy - Patients must not have active symptomatic multiple myeloma, as defined by 2015 International Myeloma Working Group (IMWG) criteria (hypercalcemia, renal failure, anemia, and bone [CRAB] criteria; bone marrow plasmacytosis > 60%); kappa: lambda ratio > 100 is acceptable only if the clinical symptoms and sign are attributable only to amyloidosis and not multiple myeloma (hemoglobin [Hgb] < 8 g/dL) - Patient must be relapsed or refractory to at least one prior line of therapy (such as: transplant, radiation, or chemotherapy) - Patients must have completed other systemic therapy >= 14 days or investigational drug >= 28 days prior to registration, surgery (other than biopsies) >= 21 days prior to registration, and any autologous stem cell transplant (ASCT) >= 100 days prior to registration - Patients must not have received any or supplements which have been known to have some anti-amyloidogenic effect (such as: doxycycline; curcumin; prednisone; dexamethasone; epigallocatechin gallate [EGCG]) within 14 days prior to registration - Patients must not have any known allergies to isatuximab or other monoclonal antibody therapies - Patients must not have received daratumumab within 56 days prior to registration nor have been refractory to daratumumab - Patients must not be eligible for autologous stem cell transplantation - Patients must have a complete medical history and physical exam within 14 days prior to registration - Within 14 days prior to registration: Total bilirubin =< 2.0 x IULN (institutional upper limit of the norm) AND - Within 14 days prior to registration: Serum glutamic-oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) and serum glutamate pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) =< 4.0 x IULN - Creatinine clearance (CrCl) >= 25 mL/min, as measured by a 24-hour urine collection or as estimated by the Cockcroft and Gault formula; the serum creatinine value used in the calculation must have been obtained within 35 days prior to registration - Patients must have bone marrow aspirate, including fluorescence in situ hybridization (FISH) (including: del 17p; t11;14; t4;14, t14;16; and del 13q) and cytogenetic testing (normal ? XY; and all abnormalities) within 35 days prior to registration; central pathology analysis will not be required, however the local pathology report and FISH/cytogenetic data must be submitted in Medidata RAVE - Within 14 days prior to registration: Absolute neutrophil count (ANC) >= 1,000 cells/mcl without growth factor support, AND - Within 14 days prior to registration: Platelets >= 75,000 cells/mcl - Patients must have hemoglobin >= 8 g/dL within 14 days prior to registration; patients may have received transfusion if greater than 7 days prior to registration - New York Heart Association (NYHA) < class IV heart failure - Left ventricular ejection fraction (LVEF) by echocardiogram (ECHO) >= 35% within 35 days prior to registration; and - NT-proBNP =< 8500 ng/L within 14 days prior to registration - Patients must have a Zubrod performance status =< 2 - Patients must not have any clinically significant uncontrolled systemic illness, including but not limited to uncontrolled, active infection requiring intravenous antibiotics, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmias, uncontrolled hypertension, or uncontrolled diabetes mellitus - Uncontrolled diabetes: patients who have a diagnosis of diabetes must have an glycosylated hemoglobin (HbA1C) < 7% within 14 days prior to registration; the same criterion will be used in patients with confirmed diagnosis of diabetes mellitus who have been on a stable dietary or therapeutic regimen for this condition in the last three months - Uncontrolled blood pressure and hypertension: all blood pressure measurements within the 14 days prior to registration must be systolic blood pressure (SBP) =< 160 and diastolic blood pressure (DBP) =< 100; an exception can be made by a healthcare provider for a patient with a single blood pressure elevation who upon rechecking has a normal blood pressure - Females of childbearing potential must have a negative baseline pregnancy test within 14 days prior to registration; this may be either a serum or urine pregnancy test, with a sensitivity of at least 50 mIU/mL; females of childbearing potential (FCBP) must also agree: (1) to have a pregnancy test prior to the start of each treatment cycle and (2) to either commit to continued abstinence from heterosexual intercourse or to use effective contraception while receiving study drug and for at least 12 weeks after receiving the last dose of study drug; females are considered to be of ?childbearing potential? if they have had menses at any time in the preceding 24 consecutive months; in addition to routine contraceptive methods, ?effective contraception? also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, she is responsible for beginning contraceptive measures - Patients with evidence of hepatitis B virus (HBV) are eligible provided there is minimal hepatic injury and the patient has undetectable HBV on suppressive HBV therapy; patient must be willing to maintain adherence to HBV therapy; patients with previously treated and eradicated hepatitis C virus (HCV) who have minimal hepatic injury are eligible - Patients who are known to be human immunodeficiency virus (HIV)-positive at registration are eligible if at time of registration they meet all other protocol eligibility criteria in addition to the following: - Patient has undetectable HIV viral load by standard polymerase chain reaction (PCR) clinical assay - Patient is willing to maintain adherence to combination antiretroviral therapy - Patient has no history of acquired immunodeficiency syndrome (AIDS) defining condition (other than CD4 cell count < 200 mm^3) - Patient is otherwise likely to have a near normal lifespan if not for the presence of relapsed/refractory amyloid - No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least two years

Study Design


Intervention

Biological:
Isatuximab
Given IV
Other:
Laboratory Biomarker Analysis
Correlative studies

Locations

Country Name City State
United States Providence Regional Cancer System-Aberdeen Aberdeen Washington
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Community Hospital of Anaconda Anaconda Montana
United States Alaska Breast Care and Surgery LLC Anchorage Alaska
United States Alaska Oncology and Hematology LLC Anchorage Alaska
United States Alaska Women's Cancer Care Anchorage Alaska
United States Anchorage Associates in Radiation Medicine Anchorage Alaska
United States Anchorage Oncology Centre Anchorage Alaska
United States Anchorage Radiation Therapy Center Anchorage Alaska
United States Katmai Oncology Group Anchorage Alaska
United States Providence Alaska Medical Center Anchorage Alaska
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Harold Alfond Center for Cancer Care Augusta Maine
United States Rocky Mountain Cancer Centers-Aurora Aurora Colorado
United States Rush - Copley Medical Center Aurora Illinois
United States The Medical Center of Aurora Aurora Colorado
United States University of Colorado Hospital Aurora Colorado
United States Saint Alphonsus Medical Center-Baker City Baker City Oregon
United States Eastern Maine Medical Center Bangor Maine
United States Flaget Memorial Hospital Bardstown Kentucky
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Waldo County General Hospital Belfast Maine
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Saint Charles Health System Bend Oregon
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford Biddeford Maine
United States Billings Clinic Cancer Center Billings Montana
United States Saint Vincent Frontier Cancer Center Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Saint Luke's Mountain States Tumor Institute Boise Idaho
United States Central Care Cancer Center - Bolivar Bolivar Missouri
United States Parkland Health Center-Bonne Terre Bonne Terre Missouri
United States Boston Medical Center Boston Massachusetts
United States Boulder Community Hospital Boulder Colorado
United States Rocky Mountain Cancer Centers-Boulder Boulder Colorado
United States Bozeman Deaconess Hospital Bozeman Montana
United States Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington
United States Harrison Medical Center Bremerton Washington
United States Lafayette Family Cancer Center-EMMC Brewer Maine
United States United Hospital Center Bridgeport West Virginia
United States IHA Hematology Oncology Consultants-Brighton Brighton Michigan
United States Saint Joseph Mercy Brighton Brighton Michigan
United States Saint Joseph Regional Cancer Center Bryan Texas
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Highline Medical Center-Main Campus Burien Washington
United States Fairview Ridges Hospital Burnsville Minnesota
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Cambridge Medical Center Cambridge Minnesota
United States IHA Hematology Oncology Consultants-Canton Canton Michigan
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Joseph Mercy Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States Caro Cancer Center Caro Michigan
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Centralia Oncology Clinic Centralia Illinois
United States Providence Regional Cancer System-Centralia Centralia Washington
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina
United States Memorial Hospital Chattanooga Tennessee
United States IHA Hematology Oncology Consultants-Chelsea Chelsea Michigan
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Cheyenne Regional Medical Center-West Cheyenne Wyoming
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States TriHealth Cancer Institute-Anderson Cincinnati Ohio
United States TriHealth Cancer Institute-Westside Cincinnati Ohio
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Providence Oncology and Hematology Care Southeast Clackamas Oregon
United States Hematology Oncology Consultants-Clarkston Clarkston Michigan
United States Newland Medical Associates-Clarkston Clarkston Michigan
United States Case Western Reserve University Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Southeastern Medical Oncology Center-Clinton Clinton North Carolina
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Billings Clinic-Cody Cody Wyoming
United States Kootenai Medical Center Coeur d'Alene Idaho
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado
United States Memorial Sloan Kettering Commack Commack New York
United States Mercy Hospital Coon Rapids Minnesota
United States Bay Area Hospital Coos Bay Oregon
United States Commonwealth Cancer Center-Corbin Corbin Kentucky
United States Alegent Health Mercy Hospital Council Bluffs Iowa
United States Greater Regional Medical Center Creston Iowa
United States Carle on Vermilion Danville Illinois
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Colorado Blood Cancer Institute Denver Colorado
United States Denver Health Medical Center Denver Colorado
United States National Jewish Health-Main Campus Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rocky Mountain Cancer Centers-Midtown Denver Colorado
United States Rocky Mountain Cancer Centers-Rose Denver Colorado
United States Rose Medical Center Denver Colorado
United States SCL Health Saint Joseph Hospital Denver Colorado
United States The Women's Imaging Center Denver Colorado
United States Western Surgical Care Denver Colorado
United States Smilow Cancer Hospital-Derby Care Center Derby Connecticut
United States Medical Oncology and Hematology Associates-Laurel Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Mercy Medical Center Durango Colorado
United States Southwest Oncology PC Durango Colorado
United States Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan
United States Pocono Medical Center East Stroudsburg Pennsylvania
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Fairview-Southdale Hospital Edina Minnesota
United States Swedish Cancer Institute-Edmonds Edmonds Washington
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Walter Knox Memorial Hospital Emmett Idaho
United States Comprehensive Cancer Care and Research Institute of Colorado LLC Englewood Colorado
United States Swedish Medical Center Englewood Colorado
United States Saint Elizabeth Hospital Enumclaw Washington
United States Illinois CancerCare-Eureka Eureka Illinois
United States Providence Regional Cancer Partnership Everett Washington
United States Smilow Cancer Hospital Care Center-Fairfield Fairfield Connecticut
United States Weisberg Cancer Treatment Center Farmington Hills Michigan
United States Saint Francis Hospital Federal Way Washington
United States Genesee Cancer and Blood Disease Treatment Center Flint Michigan
United States Genesee Hematology Oncology PC Flint Michigan
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Poudre Valley Hospital Fort Collins Colorado
United States Unity Hospital Fridley Minnesota
United States Saint Luke's Mountain States Tumor Institute - Fruitland Fruitland Idaho
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Central Care Cancer Center - Garden City Garden City Kansas
United States Mountain Blue Cancer Care Center Golden Colorado
United States National Jewish Health-Western Hematology Oncology Golden Colorado
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States Wayne Memorial Hospital Goldsboro North Carolina
United States CHI Health Saint Francis Grand Island Nebraska
United States Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado
United States Central Care Cancer Center - Great Bend Great Bend Kansas
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
United States East Carolina University Greenville North Carolina
United States Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan
United States Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan
United States Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan
United States Memorial Sloan Kettering Westchester Harrison New York
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States Lehigh Valley Hospital-Hazleton Hazleton Pennsylvania
United States Saint Peter's Community Hospital Helena Montana
United States Pulmonary Medicine Center of Chattanooga-Hixson Hixson Tennessee
United States CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
United States Centerpoint Medical Center LLC Independence Missouri
United States Swedish Cancer Institute-Issaquah Issaquah Washington
United States Mayo Clinic in Florida Jacksonville Florida
United States Onslow Memorial Hospital Jacksonville North Carolina
United States Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina
United States Capital Region Southwest Campus Jefferson City Missouri
United States Kalispell Regional Medical Center Kalispell Montana
United States Research Medical Center Kansas City Missouri
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States CHI Health Good Samaritan Kearney Nebraska
United States Heartland Hematology and Oncology Kearney Nebraska
United States Kadlec Clinic Hematology and Oncology Kennewick Washington
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Providence Regional Cancer System-Lacey Lacey Washington
United States Good Samaritan Medical Center Lafayette Colorado
United States Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado
United States Saint Anthony Hospital Lakewood Colorado
United States Saint Clare Hospital Lakewood Washington
United States Sparrow Hospital Lansing Michigan
United States Lawrence Memorial Hospital Lawrence Kansas
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States Kansas Institute of Medicine Cancer and Blood Center Lenexa Kansas
United States Minimally Invasive Surgery Hospital Lenexa Kansas
United States Saint Joseph Hospital East Lexington Kentucky
United States Saint Joseph Radiation Oncology Resource Center Lexington Kentucky
United States Saint Elizabeth Regional Medical Center Lincoln Nebraska
United States Littleton Adventist Hospital Littleton Colorado
United States Rocky Mountain Cancer Centers-Littleton Littleton Colorado
United States Hope Cancer Clinic Livonia Michigan
United States Saint Mary Mercy Hospital Livonia Michigan
United States Saint Joseph London London Kentucky
United States Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado
United States Sky Ridge Medical Center Lone Tree Colorado
United States Longmont United Hospital Longmont Colorado
United States Rocky Mountain Cancer Centers-Longmont Longmont Colorado
United States PeaceHealth Saint John Medical Center Longview Washington
United States Jewish Hospital Louisville Kentucky
United States Jewish Hospital Medical Center Northeast Louisville Kentucky
United States Saints Mary and Elizabeth Hospital Louisville Kentucky
United States McKee Medical Center Loveland Colorado
United States Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan
United States Illinois CancerCare-Macomb Macomb Illinois
United States Michigan Breast Specialists-Macomb Township Macomb Michigan
United States Fairview Maple Grove Medical Center Maple Grove Minnesota
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States WVUH-Berkely Medical Center Martinsburg West Virginia
United States Fremont - Rideout Cancer Center Marysville California
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Loyola University Medical Center Maywood Illinois
United States Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park Illinois
United States Idaho Urologic Institute-Meridian Meridian Idaho
United States Saint Luke's Mountain States Tumor Institute - Meridian Meridian Idaho
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Community Medical Hospital Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Monticello Cancer Center Monticello Minnesota
United States West Virginia University Healthcare Morgantown West Virginia
United States Saint Alphonsus Medical Center-Nampa Nampa Idaho
United States Saint Luke's Mountain States Tumor Institute - Nampa Nampa Idaho
United States Smilow Cancer Center/Yale-New Haven Hospital New Haven Connecticut
United States Yale University New Haven Connecticut
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States Memorial Sloan Kettering Cancer Center New York New York
United States NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York
United States Providence Newberg Medical Center Newberg Oregon
United States Yale-New Haven Hospital North Haven Medical Center North Haven Connecticut
United States Stephens Memorial Hospital Norway Maine
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Alegent Health Lakeside Hospital Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Hematology and Oncology Consultants PC Omaha Nebraska
United States Saint Alphonsus Medical Center-Ontario Ontario Oregon
United States Memorial GYN Plus Ooltewah Tennessee
United States Smilow Cancer Hospital-Orange Care Center Orange Connecticut
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Menorah Medical Center Overland Park Kansas
United States Saint Luke's South Hospital Overland Park Kansas
United States Midlands Community Hospital Papillion Nebraska
United States Parker Adventist Hospital Parker Colorado
United States Rocky Mountain Cancer Centers-Parker Parker Colorado
United States Camden Clark Medical Center Parkersburg West Virginia
United States Illinois CancerCare-Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States 21st Century Oncology-Pontiac Pontiac Michigan
United States Hope Cancer Center Pontiac Michigan
United States Newland Medical Associates-Pontiac Pontiac Michigan
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Kaiser Permanente Northwest Portland Oregon
United States Oregon Health and Science University Portland Oregon
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Kootenai Cancer Center Post Falls Idaho
United States Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington
United States Fairview Northland Medical Center Princeton Minnesota
United States Illinois CancerCare-Princeton Princeton Illinois
United States Rocky Mountain Cancer Centers - Pueblo Pueblo Colorado
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States Saint Charles Health System-Redmond Redmond Oregon
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Mayo Clinic Rochester Minnesota
United States University of Rochester Rochester New York
United States Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills Michigan
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Siteman Cancer Center-South County Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Kootenai Cancer Clinic Sandpoint Idaho
United States MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford Maine
United States Kaiser Permanente Washington Seattle Washington
United States Pacific Gynecology Specialists Seattle Washington
United States Swedish Medical Center-Ballard Campus Seattle Washington
United States Swedish Medical Center-Cherry Hill Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States PeaceHealth United General Medical Center Sedro-Woolley Washington
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Providence Regional Cancer System-Shelton Shelton Washington
United States Jewish Hospital Medical Center South Shepherdsville Kentucky
United States Welch Cancer Center Sheridan Wyoming
United States Memorial Medical Center Springfield Illinois
United States Mercy Medical Center Springfield Massachusetts
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan
United States Marshfield Clinic Stevens Point Center Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri
United States Cancer Care Specialists of Illinois-Swansea Swansea Illinois
United States Southwest Illinois Health Services LLP Swansea Illinois
United States Franciscan Research Center-Northwest Medical Plaza Tacoma Washington
United States Northwest Medical Specialties PLLC Tacoma Washington
United States Ascension Saint Joseph Hospital Tawas City Michigan
United States National Jewish Health-Northern Hematology Oncology Thornton Colorado
United States Rocky Mountain Cancer Centers-Thornton Thornton Colorado
United States Smilow Cancer Hospital-Torrington Care Center Torrington Connecticut
United States Smilow Cancer Hospital Care Center-Trumbull Trumbull Connecticut
United States Saint Luke's Mountain States Tumor Institute-Twin Falls Twin Falls Idaho
United States Memorial Sloan Kettering Nassau Uniondale New York
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Ridgeview Medical Center Waconia Minnesota
United States Providence Saint Mary Regional Cancer Center Walla Walla Washington
United States Advanced Breast Care Center PLLC Warren Michigan
United States Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan
United States Macomb Hematology Oncology PC Warren Michigan
United States Michigan Breast Specialists-Warren Warren Michigan
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Smilow Cancer Hospital-Waterbury Care Center Waterbury Connecticut
United States Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Cleveland Clinic-Weston Weston Florida
United States Marshfield Clinic - Weston Center Weston Wisconsin
United States SCL Health Lutheran Medical Center Wheat Ridge Colorado
United States Cancer Center of Kansas - Wichita Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Rice Memorial Hospital Willmar Minnesota
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Fairview Lakes Medical Center Wyoming Minnesota
United States Providence Regional Cancer System-Yelm Yelm Washington
United States Rush-Copley Healthcare Center Yorkville Illinois
United States Huron Gastroenterology PC Ypsilanti Michigan
United States IHA Hematology Oncology Consultants-Ann Arbor Ypsilanti Michigan

Sponsors (2)

Lead Sponsor Collaborator
SWOG Cancer Research Network National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall confirmed hematologic response rate Will include partial response, very good partial response and complete response. Hematologic response will be reported with a binomial confidence interval. Up to 4 years
Secondary Incidence of adverse events Will be evaluated using the Common Terminology Criteria for Adverse Events version 4.0. The maximum grade for each toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. Up to 4 years
Secondary Organ response Organ response will be evaluated in the subset of patients with evaluable organ involvement using current criteria. The proportion of patients with organ response will be estimated as the number of patients with documented organ response out of the number of patients with documented evaluable organ involvement at baseline. Up to 4 years
Secondary Overall survival Will be estimated using the Kaplan-Meier method. From date of registration to date of death due to any cause, assessed up to 4 years
Secondary Progression free survival Will be estimated using the Kaplan-Meier method. From date of registration to date of first documentation of progression, symptomatic deterioration, or death due to any cause, assessed up to 4 years
See also
  Status Clinical Trial Phase
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Recruiting NCT06292949 - Clinical Study of Resistant Starch in Improving Constipation N/A
Recruiting NCT04132661 - MRI Assessment of Mode of Action of Bisacodyl, Single Dose Phase 4
Terminated NCT02839889 - Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation) Phase 4
Completed NCT02726295 - The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®) for Chronic Constipation:Multicenter Study Phase 4
Recruiting NCT02255747 - Anal Dilatation for Infants and Children With Constipation N/A
Completed NCT02246647 - Biomarkers for Intestinal Permeability in Patients With Constipation
Completed NCT01566409 - Maintenance Treatment for Children With Constipation N/A
Completed NCT02658201 - Ultrafast MRI Imaging to Exclude Constipation N/A
Completed NCT02863848 - Effect of Inulin-type Fructans on Constipated Children. N/A
Completed NCT01695915 - Diurnal Variation in Rectal Diameter N/A
Completed NCT01710579 - Normal Values in Ano-rectal 3D High Resolution Manometry N/A
Completed NCT01438567 - A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy Phase 3
Completed NCT01411501 - Efficacy and Safety of Acupuncture for Functional Constipation Phase 3
Completed NCT01474499 - A Trial of Docusate Sodium and Sorbitol Rectal Solution for the in Patients With Constipation Phase 3
Completed NCT01170039 - The Effectiveness of Lubiprostone in Constipated Diabetics Phase 4
Completed NCT00931853 - Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC). Phase 3
Active, not recruiting NCT02442115 - Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
Completed NCT00994851 - Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment. Phase 3
Terminated NCT01003249 - Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen Phase 4