Donor Stem Cell Transplant in Treating Patients With High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT ID: NCT01027000
Last Updated: 2023-05-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
68 participants
INTERVENTIONAL
2010-02-28
2023-04-30
Brief Summary
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PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma.
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Detailed Description
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Primary
* To determine if this treatment can improve 2-year current progression-free survival (PFS) in the early disease cohort compared to historical controls. Specifically, we plan to study whether we can achieve 2-year PFS ≥ 70% and to exclude 2 year PFS ≤ 50%
Secondary
* To determine whether in the advanced disease cohort we can achieve 2-year current PFS ≥ 50% and to exclude 2-year PFS ≤ 30%
* To assess objective response rate.
* To assess the incidence of grade 2-4 and 3-4 acute graft-vs-host disease (GVHD).
* To assess the incidence of extensive chronic GVHD.
* To assess the incidence of treatment-related mortality at 100 days and 1 year
* To assess overall survival
* To assess donor chimerism for CD3+ cells at 1 and 2 years after transplantation
* To investigate the presence of donor antigen-specific T-cell clones before and after withdrawal of immune suppression.
* To compare the relapse profiles of patients with T-cell responses against CLL to those whose CLL cells are not reactive
* To prospectively examine the impact of high-risk genomic features and immune-based single nucleotide polymorphisms on response, toxicity, and 2-year PFS to reduced intensity allogeneic stem cell transplant
OUTLINE: This is a multicenter study.
* Preparative regimen: Patients receive 1 of 2 preparative regimens at the discretion of the participating institution.
* Preparative regimen 1: Patients receive rituximab IV on days -7, -1, 7, and 14 and fludarabine phosphate IV over 30 minutes and busulfan IV over 3 hours on days -5 to -2. .
* Preparative regimen 2: Patients receive rituximab IV on days -7, -1, 7, and 14, fludarabine phosphate IV over 30 minutes on days -5 to -2, and cyclophosphamide IV over 1-2 hours on days -5 to -3. Patients with matched unrelated donors also receive anti-thymocyte globulin IV over 4-6 hours on days -6 to -4.
* Graft-vs-host disease (GVHD) prophylaxis: Patients who receive preparative regimen 1 may receive either GVHD prophylaxis regimen 1 or 2; patients who receive preparative regimen 2 may only receive GVHD prophylaxis regimen 2.
* GVHD prophylaxis regimen 1: Patients receive tacrolimus either orally or IV and oral sirolimus beginning on day -2 and continuing until day 60, followed by a taper until day 180. Patients also receive methotrexate IV on days 1, 3, and 6.
* GVHD prophylaxis regimen 2: Patients receive tacrolimus either orally or IV beginning on day -2 and continuing until day 60, followed by a taper until day 180. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
* Transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
* Maintenance therapy: Patients receive rituximab IV at 3, 6, 9, and 12 months after transplantation.
Peripheral blood and bone marrow aspirate samples may be collected periodically for correlative laboratory studies.
Patients are followed up periodically for a maximum of 5 years from study entry.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (Combination of chemotherapy and transplant)
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rituximab
busulfan
cyclophosphamide
fludarabine phosphate
methotrexate
sirolimus
tacrolimus
allogeneic stem cell transplant
Interventions
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rituximab
busulfan
cyclophosphamide
fludarabine phosphate
methotrexate
sirolimus
tacrolimus
allogeneic stem cell transplant
Eligibility Criteria
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Inclusion Criteria
5. There will be no donor age restriction.
18 Years
69 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Genentech, Inc.
INDUSTRY
Biologics, Inc.
INDUSTRY
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Edwin P. Alyea, MD
Role: STUDY_CHAIR
Dana-Farber Cancer Institute
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Union Hospital of Cecil County
Elkton, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Monter Cancer Center of the North Shore-LIJ Health System
Lake Success, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States
Countries
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Other Identifiers
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CDR0000660555
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2011-01995
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB 100701
Identifier Type: -
Identifier Source: org_study_id
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