Status:
COMPLETED
Donor T Cells After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Accelerated Phase Chronic Myelogenous Leukemia
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Eligibility:
All Genders
14-75 years
Phase:
PHASE2
Brief Summary
This pilot phase II trial studies how well giving donor T cells after donor stem cell transplant works in treating patients with hematologic malignancies. In a donor stem cell transplant, the donated ...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the feasibility of escalating dose regimen (EDR) donor lymphocyte infusion (DLI) as measured by the proportion of patients who receive at least one DLI. SECONDARY...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA PRIOR TO TRANSPLANT:
- The clinical trial will be offered to all high risk (defined 3 below) patients with hematologic malignancies who require stem cell transplants as part of their standard of care using matched related or unrelated donors
- Patients with high risk myeloid or lymphoid malignancies at stem cell transplant following American Society for Blood and Marrow Transplantation (ASBMT) criteria, including but not limited to conditions listed; these criteria apply BEFORE cyto-reductive therapy given within 28 days of planned conditioning:
- Refractory acute myelogenous or lymphoid leukemia
- Relapsed acute myelogenous or lymphoid leukemia
- Myelodysplastic syndromes with 5% or more blasts
- Chronic myelogenous leukemia in chronic phase 3 or more, blast phase presently, or second accelerated phase
- Recurrent or refractory malignant lymphoma or Hodgkin's disease with less than a partial response at transplant
- High risk chronic lymphocytic leukemia defined as no response or stable disease to the most recent treatment regimen
- DONORS: Matched related or unrelated donor stem cell transplant (SCT) matched at human leukocyte antigen (HLA) A- B, C, and DRB1 by molecular methods; 7 of 8 matched donor acceptable for related donors
- T-cell depletion with anti-thymocyte globulin (ATG) (rabbit or horse) or at least 30 mg of alemtuzumab total in the conditioning regimen
- Immune suppression; planned post-transplant immune suppression should include tacrolimus or cyclosporin monotherapy (i.e., calcineurin inhibitor or CN) for alemtuzumab regimens and a second immune suppressant for ATG treated patients; other agents may be used if CN intolerance or toxicity occurs post-transplant
- Zubrod performance status (PS) 0-2 or equivalent Karnofsky PS
- Eligible for allogeneic transplant in the treating physicians' judgment and by institutional standards
- ELIGIBILITY TO RECEIVE DLI POST-TRANSPLANT:
- Donor lymphocytes available or able to be collected
- No evidence of disease by standard morphology; minimal residual disease or molecular evidence of disease will not exclude
- Absolute neutrophil count \>= 500/μl
- Platelet count \>= 20,000/μl without transfusion for 7 days
- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =\< 5 x upper limit of normal (ULN)
- Bilirubin =\< 3 x ULN
- No evidence of grade II or higher acute GVHD or chronic GVHD at initiation of first DLI
- No systemic corticosteroids or immunosuppressive drugs (topical acceptable); replacement steroids for adrenal insufficiency are not excluded
Exclusion
- EXCLUSION CRITERIA PRIOR TO TRANSPLANT:
- Pregnant or lactating females
- Hepatitis B with positive viral load prior to transplant conditioning or hepatitis C virus
- Human immune deficiency virus
- Psychiatric illness that may make compliance to the clinical protocol unmanageable or may compromise the ability of the patient to give informed consent
- Creatinine \>= 2.0 mg/dL
- SGOT and SGPT \>= 5 x ULN; liver biopsy preferred for such patients
- Bilirubin \>= 3 x ULN (unless Gilbert's syndrome)
- Diffusing capacity of the lung for carbon monoxide (DLCO) \< 50% corrected for hemoglobin
- Left ventricular ejection fraction or shortening fraction \< 40%
- Unlikely to be able to procure additional donor lymphocytes
Key Trial Info
Start Date :
April 4 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT01839916
Start Date
April 4 2013
End Date
August 1 2018
Last Update
August 7 2019
Active Locations (1)
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1
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470