Leukemia Clinical Trial
Official title:
Antibody Therapy With Alemtuzumab, Rituximab and GM-CSF for Initial Treatment of High Risk Chronic Lymphocytic Leukemia
Verified date | May 2017 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth
in different ways. Some block the ability of cancer cells to grow and spread. Others find
cancer cells and help kill them or carry cancer-killing substances to them.
Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in
bone marrow or peripheral blood. Giving monoclonal antibody therapy together with GM-CSF may
be an effective treatment for early-stage chronic lymphocytic leukemia.
PURPOSE: This phase II trial is studying the side effects of giving rituximab and alemtuzumab
together with GM-CSF and to see how well it works in treating patients with early-stage
chronic lymphocytic leukemia.
Status | Completed |
Enrollment | 33 |
Est. completion date | December 18, 2014 |
Est. primary completion date | February 5, 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of chronic lymphocytic leukemia (CLL) meeting the following criteria: - Minimum threshold peripheral blood lymphocyte count 5 x 10^9/L - Monoclonality (light chain exclusion) of B lymphocytes detected by immunophenotyping (CD19-positive), demonstrating = 3 of the following characteristics: - CD5-positive - CD23-positive - Dim surface light chain expression - Dim surface CD20 expression - Negative for IGH/CCND1 translocation AND/OR immunostaining is negative for cyclin D1 expression by fluorescent in-situ hybridization (FISH) analysis - Rai stage 0, I, or II disease that does not meet standard NCI-Working Group criteria for treatment of CLL - Poor prognosis as defined by = 1 of the following factors: - Unmutated IgVH mutation status AND CD38 expression (i.e., = 30% cells positive on flow cytometry) - Unmutated IgVH mutation status AND ZAP-70 expression (i.e., = 20% cells positive on flow cytometry) - VH3-21 gene segment use irrespective of mutation status AND CD38 expression (= 30% cells positive on flow cytometry) - VH3-21 gene segment use irrespective of mutation status AND ZAP-70 expression (= 20% cells positive on flow cytometry) - 11q-negative* - 17p-negative* NOTE: *Determination of IgVH mutation status is not required in patients whose eligibility is based on 17p13- or 11q22- deletions PATIENT CHARACTERISTICS: - ECOG performance status 0- 2 - Creatinine = 1.5 times upper limit of normal (ULN) - Total bilirubin = 3.0 times ULN OR direct bilirubin = 1.5 ULN - AST = 3.0 times ULN (unless due to hemolysis or CLL) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must practice effective contraception - Willing to provide mandatory blood samples (for patients at the Mayo Clinic in Rochester only) for research studies as required by the protocol - No comorbid conditions, including any of the following: - New York Heart Association Class III or IV heart disease - Myocardial infarction within the past month - Uncontrolled infection - HIV infection or AIDS - Serological evidence of active hepatitis B infection (i.e., serum antigen or e-antigen positivity) or positive hepatitis C serology - No other active primary malignancy requiring treatment or limiting survival to = 2 years - No active autoimmune hemolytic anemia, immune thrombocytopenia, or pure red blood cell aplasia PRIOR CONCURRENT THERAPY: - More than 4 weeks since prior major surgery - No prior chemotherapy or monoclonal antibody treatment for CLL - No concurrent corticosteroids |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Mayo Clinic Scottsdale | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Confirmed Responses (Complete or Partial Response Noted as the Objective Status for a Duration of at Least 2 Months) at 6 Months | Response, as defined by the National Cancer Institute Working Group (NCIWG), requires the following for a period of at least 2 months: CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus =1 of the following: =1500/µL polymorphonuclear leukocytes, >100,000/µL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions |
6 months | |
Secondary | Progression Free Survival | Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to the standard NCI-WG96 criteria. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. | Time from registration to progression (up to 5 years) | |
Secondary | Duration of Response | Duration of response (DOR) is defined as the time from documentation of response (CR or PR) to disease progression. The median DOR with 95% CI was estimated using the Kaplan Meier method.Response, as defined by the National Cancer Institute Working Group (NCIWG), requires the following for a period of at least 2 months: CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus =1 of the following: =1500/µL polymorphonuclear leukocytes, >100,000/µL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions |
time from start of response to progression (up to 5 years) | |
Secondary | Time to Next Treatment | Time to next treatment was defined as the time from end of active (protocol) treatment to the start of subsequent treatment. The median and 95% CI was estimated using the Kaplan Meier method. | time from end of protocol treatment to subsequent treatment (up to 5 years) | |
Secondary | Overall Survival | Overall Survival (OS) was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from registration. The median OS with 95% CI was estimated using the Kaplan Meier method. | Time from registration to death (up to 5 years) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05691608 -
MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2
|
N/A | |
Recruiting |
NCT04092803 -
Virtual Reality as a Distraction Technique for Performing Lumbar Punctures in Children and Young Adu
|
N/A | |
Active, not recruiting |
NCT02530463 -
Nivolumab and/or Ipilimumab With or Without Azacitidine in Treating Patients With Myelodysplastic Syndrome
|
Phase 2 | |
Completed |
NCT00948064 -
Vorinostat in Combination With Azacitidine in Patients With Newly-Diagnosed Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)
|
Phase 2 | |
Completed |
NCT04474678 -
Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!")
|
N/A | |
Terminated |
NCT00801931 -
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
|
Phase 1/Phase 2 | |
Recruiting |
NCT03948529 -
RevErsing Poor GrAft Function With eLtrombopag After allogeneIc Hematopoietic Cell trAnsplantation
|
Phase 2 | |
Completed |
NCT01682226 -
Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies
|
Phase 2 | |
Completed |
NCT00003270 -
Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT02723994 -
A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia
|
Phase 2 | |
Terminated |
NCT02469415 -
Pacritinib for Patients With Lower-Risk Myelodysplastic Syndromes (MDS)
|
Phase 2 | |
Recruiting |
NCT04856215 -
90Y-labelled Anti-CD66 ab in Childhood High Risk Leukaemia
|
Phase 2 | |
Recruiting |
NCT06155188 -
Post-transplant PT/FLU+CY Promotes Unrelated Cord Blood Engraftment in Haplo-cord Setting in Childhood Leukemia
|
N/A | |
Completed |
NCT00001637 -
Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults
|
Phase 2 | |
Active, not recruiting |
NCT04188678 -
Resiliency in Older Adults Undergoing Bone Marrow Transplant
|
N/A | |
Completed |
NCT02910583 -
Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)
|
Phase 2 | |
Completed |
NCT01212926 -
Early Detection of Anthracycline Cardiotoxicity by Echocardiographic Analysis of Myocardial Deformation in 2D Strain
|
N/A | |
Terminated |
NCT00014560 -
Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Recruiting |
NCT04977024 -
SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer
|
Phase 2 | |
Recruiting |
NCT05866887 -
Insomnia Prevention in Children With Acute Lymphoblastic Leukemia
|
N/A |