Acute Myeloid Leukemia Clinical Trial
Official title:
Phase IIB, Multicenter, Randomized, Open Label Trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients With Untreated AML 60-75 Years of Age.
Verified date | October 2017 |
Source | Jazz Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study investigates if CPX-351 will be a) more effective than the standard AML treatment
and b) more tolerable than the standard AML treatment regimens.
The study compares the investigational product CPX-351 vs the standard treatment for AML in
this patients age group.
Status | Completed |
Enrollment | 126 |
Est. completion date | December 2011 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Age =60 and <76 years at the time of diagnosis of AML - Pathological confirmation of AML - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Able to adhere to the study visit schedule and other protocol requirements - Laboratory values fulfilling the following: Serum creatinine < 2.0 mg/dL Serum total bilirubin < 2.0 mg/dL Serum alanine aminotransferase or aspartate aminotransferase < 150 IU/liter Note: If elevated liver enzymes are related to disease; contact medical monitor to discuss. - Cardiac ejection fraction > 50% by echocardiography or MUGA scan Exclusion Criteria: - Patients with locally advanced or metastatic solid tumors =5 years from initial diagnosis are excluded. (Patients with locally advanced or metastatic solid tumors >5 years from initial diagnosis, for whom the investigator has no clinical suspicion of active disease for >2 years before randomization are eligible) - Prior treatment for AML; only hydroxyurea is permitted (see below) - Acute promyelocytic leukemia [t(15;17)] or favorable cytogenetics, including t(8;21) or inv16 if known at the time of randomization - Patients with a prior anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent) - Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent - Administration of any antineoplastic therapy within 4 weeks of the first CPX-351 dose; in the event of rapidly proliferative disease use of hydroxyurea is permitted until 24 hours before the start of study treatment - Clinical evidence of active CNS leukemia - Patients with history of and/or current evidence of myocardial impairment (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Class III or IV staging - Active and uncontrolled infection. Patients with an infection receiving treatment with antibiotics may be entered into the study if they are afebrile and hemodynamically stable for 72 hrs. - Current evidence of invasive fungal infection (blood or tissue culture); HIV or active hepatitis C infection - Hypersensitivity to cytarabine, daunorubicin or liposomal products - History of Wilson's disease or other copper-related disorder |
Country | Name | City | State |
---|---|---|---|
Canada | Queen Elisabeth II Health Sciences Center | Halifax | Nova Scotia |
Canada | McGill University Department of Oncology | Montreal | Quebec |
Canada | BC Cancer Research Center | Vancouver | British Columbia |
United States | Blood and Marrow Transplant Group of Georgia | Atlanta | Georgia |
United States | University of Colorado Cancer Center | Aurora | Colorado |
United States | St.Francis Hospital | Beech Grove | Indiana |
United States | Blumenthal Cancer Center/Mecklenburg Medical Group | Charlotte | North Carolina |
United States | Robert H.Lurie Comprehensive Cancer Center | Chicago | Illinois |
United States | Rush University Medical Center | Chicago | Illinois |
United States | Jewish Hospital | Cincinnati | Ohio |
United States | Northern New Jersey Cancer Associates | Hackensack | New Jersey |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | Shands Jacksonville Medical Center | Jacksonville | Florida |
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Cedars Sinai Medical Center | Los Angeles | California |
United States | Joe Arrington Cancer Center | Lubbock | Texas |
United States | Texas Tech University Health Sciences Center | Lubbock | Texas |
United States | North Shore University Hospital | Manhasset | New York |
United States | Froedlert Hospital/Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Weil Cornell Medical Center | New York | New York |
United States | University of Pittsburg Cancer Center | Pittsburgh | Pennsylvania |
United States | Oregon Health and Science University | Portland | Oregon |
United States | UC Davis Cancer Center | Sacramento | California |
United States | Cancer Therapy and Research Center at the University of Texas | San Antonio | Texas |
United States | University of California Medical Center | San Francisco | California |
United States | H Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
United States | Arizona Cancer Center | Tucson | Arizona |
United States | New York Medical College, Division of Oncology | Valhalla | New York |
Lead Sponsor | Collaborator |
---|---|
Jazz Pharmaceuticals |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Complete Remission | Response was defined according to International Working Group Criteria (Cheson, et al. 2003) which requires peripheral blood neutrophils of >1000/µL and peripheral blood platelets of >100,000/µL in the absence of bone marrow blasts. | Within 6 weeks of the last induction treatment | |
Secondary | Remission Duration/Time to Remission | Remission Duration was assessed from the time measurement criteria for CR were met until the first date that disease relapse was objectively documented or the subject died. Time to remission was measured from the date of randomization to the time measurement criteria for CR were first met. |
Following achievement of CR over the study period | |
Secondary | Event Free Survival | Event-free survival begins from randomization to the date persistent disease is documented or date of relapse after CR, or death, whichever comes first. | Up to 1 year from randomization | |
Secondary | Overall Survival Rate at 1 Year | Survival defined as the time from randomization to death. | 1 year | |
Secondary | Rate of Stem Cell Transplant | The rate of patients who underwent stem cell transplant. | Up to 1 year | |
Secondary | Aplasia Rate | Bone marrow aplasia was defined as <20% cellularity and 5% blasts in the bone marrow aspiration evaluation. | Day 14 (1st Induction) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Recruiting |
NCT04460235 -
Immunogenicity of an Anti-pneumococcal Combined Vaccination in Acute Leukemia or Lymphoma
|
Phase 4 | |
Completed |
NCT03678493 -
A Study of FMT in Patients With AML Allo HSCT in Recipients
|
Phase 2 | |
Completed |
NCT04022785 -
PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
|
Phase 1 | |
Recruiting |
NCT05424562 -
A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Canada
|
||
Terminated |
NCT03224819 -
Study of Emerfetamab (AMG 673) in Adults With Relapsed/Refractory Acute Myeloid Leukemia (AML)
|
Early Phase 1 | |
Completed |
NCT03197714 -
Clinical Trial of OPB-111077 in Patients With Relapsed or Refractory Acute Myeloid Leukaemia
|
Phase 1 | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Active, not recruiting |
NCT04070768 -
Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113
|
Phase 1 | |
Active, not recruiting |
NCT04107727 -
Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML)
|
Phase 2 | |
Recruiting |
NCT04385290 -
Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)
|
Phase 1/Phase 2 | |
Recruiting |
NCT04920500 -
Bioequivalence of Daunorubicin Cytarabine Liposomes in Naive AML Patients
|
N/A | |
Recruiting |
NCT03897127 -
Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics
|
Phase 3 | |
Active, not recruiting |
NCT04021368 -
RVU120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome
|
Phase 1 | |
Recruiting |
NCT03665480 -
The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML
|
Phase 2/Phase 3 | |
Completed |
NCT02485535 -
Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant
|
Phase 1 | |
Enrolling by invitation |
NCT04093570 -
A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers
|
Phase 2 | |
Recruiting |
NCT04069208 -
IA14 Induction in Young Acute Myeloid Leukemia
|
Phase 2 | |
Recruiting |
NCT05744739 -
Tomivosertib in Relapsed or Refractory Acute Myeloid Leukemia (AML)
|
Phase 1 | |
Recruiting |
NCT04969601 -
Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings
|
Phase 1/Phase 2 |