Status:
TERMINATED
Post Transplant Donor Lymphocyte Infusion
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Leukemia, Myeloid, Chronic
Lymphomas
Eligibility:
All Genders
1-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test the hypothesis that a pre-infusion preparative regimen of cyclophosphamide and fludarabine will improve the effectiveness of DLI in patients with blood cancers.
Detailed Description
When cancer relapses after donor bone marrow transplantation, regular dose chemotherapy offers little hope of prolonged survival. However, there is evidence that lymphocytes can attack cancer cells. T...
Eligibility Criteria
Inclusion
- Patients (age \> or = 1 years) with a diagnosis of relapse after related or unrelated allogeneic stem cell transplantation for a hematological malignancy.
- For CML, relapse will be defined as any cytogenetic evidence of a Philadelphia chromosome or persistence of BCR/ABL rearrangements by molecular testing on at least two measurements over a 6 month interval. If cytogenetics are normal and there is PCR evidence of a BCR/ABL fusion, patients will be eligible if they have evidence of a quantitative increase in CML measured either by quantitative PCR or by fluorescent in situ hybridization (FISH).
- For non-CML, relapse will be defined based on disease specific morphologic criteria from a bone marrow biopsy and aspirate or recurrence of disease specific cytogenetics. For disease specific definition of relapse, see appendix 3. Relapse can be determined morphologically with less than 5 percent blasts if definitive relapse can be determined. Equivocal results for relapse should result in a repeated test after an appropriate time interval (suggested 1 month) to determine eligibility.
- Post-transplant lymphoproliferative diseases (often referred to as EBV-associated lymphomas) are NOT eligible for this protocol.
- For Chronic Phase CML patients only
- \- must have failed (no response in 3 months or incomplete response at 6 months) or refused treatment with Gleevec
- \- if no prior DLI, CML patients will first have DLI- if relapse occurs after DLI, DLI with chemotherapy per this protocol will be offered
- Patients must be within one year of identification of relapse or if beyond that time period, must have at least 10% donor DNA by RFLP or cytogenetics.
- Same allogeneic donor (sibling or URD) used for transplantation is available for lymphocyte donation.
- No severe organ damage (by laboratory or clinical assessment) as measured by:
- \- blood creatinine ≤ 2.0 mg/dL
- \- liver function tests \< 5 x normal
- \- left ventricular ejection fraction \> 40% (testing required only if symptomatic or prior known impairment).
- \- pulmonary functions \> 50% (testing required only if symptomatic or prior known impairment). Oxygen saturation (\>92%) can be used in child where PFT's cannot be obtained.
- \- chest x-ray without evidence of active infection
- Off prednisone and other immunosuppressive agents (given for any reason) for at least 3 days prior to DLI infusions.
- Performance status ≥ 60%
- Women must not be pregnant or lactating. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
- Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception
- Patient must given written informed consent indicating understanding of the nature of the treatment and its potential risks
Exclusion
- Concurrent signs of acute or chronic graft-versus-host disease requiring ongoing treatment at the time of relapse will be ineligible.
- Patients being treated for GVHD with prednisone, cyclosporine, Imuran or other immunosuppressive medications are not eligible until these medications are discontinued for at least 2 weeks without a flare of GVHD.
- Active CNS leukemia
- Active fungal infection or pulmonary infiltrates (stable prior treated disease is allowable)
- HIV positive
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 24 2018
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00167180
Start Date
January 1 2004
End Date
December 24 2018
Last Update
July 30 2019
Active Locations (1)
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1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455