Status:
COMPLETED
Donor Stem Cell Transplant in Treating Patients With Previously Treated Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
Up to 55 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving chemotherapy, such as cyclophosphamide and busulfan, and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's...
Detailed Description
OBJECTIVES: * Determine if allogeneic stem cell transplantation using unrelated matched or related haploidentical donor bone marrow or unrelated matched cord blood results in timely, complete, and du...
Eligibility Criteria
Inclusion
- Donors will be \<55 years of age and in good health as approved by the National Marrow Donor Program (NMDP) donor and collection centers. Related donors will be \< 70 years of age.
- Recipients will be \<55 years, will have satisfactory organ function (excluding bone marrow) and will have a Karnofsky activity assessment \>90% and will have:
- Creatinine \<2.0 mg/dl.
- Bilirubin, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<2 x normal.
- Pulmonary function test and Carbon Monoxide Diffusing Capacity (DLCO) \> 50% of normal.
- Multi Gated Acquisition Scan (MUGA) \>45% injection fraction.
- Recipients with unrelated donor matched at the HLA A, B, DRBI loci, or if \< 35 years mismatched at a single HLA A or B, or DRBI locus.
- Umbilical cord blood (5) used as an unrelated stem cell source will provide \> 2.0 x 10\^7 cells/kg and will be matched at 4 - 6 of 6 HLA A, B, and DRBI loci. Cord blood grafts may include a single or pair of cord units depending on the cell dose.
- Partially matched related donors will be at least haploidentical (matched at \>3 of 6 HLA A, B, DRB1 loci).
- Recipients will fall under one of the following disease categories
- Chronic lymphocytic leukemia -- must have all three:
- Rai Stage III/IV
- Progression after previous Complete Response (CR) or Partial Response (PR) including purine antagonist (i.e. fludarabine).
- Recent chemotherapy responsiveness
- Advanced non-Hodgkin's lymphoma(NHL).
- Low-grade NHL (Working Formulation A, B, C) following progression after initial therapy if asymptomatic at diagnosis (\>CR2, \>PR2; response duration \< 1 year from last therapy) or if no CR was achieved (\>PR1). At least one prior therapy of intermediate intensity (e.g. CHOP).
- Mantle zone lymphoma after any progression following initial therapy (\>CR1, \> PR1). At least one prior therapy of intermediate intensity (e.g. CHOP).
- Intermediate grade lymphoma (\>PR2). Response duration \<1 year from prior therapy.
- High-grade Non-Hodgkin's Lymphoma (NHL) (IWF H, I, J) after initial therapy if \>stage III at diagnosis; after any progression even if localized (stage I, II) at diagnosis with prior response duration \< 1 year.
- Recent chemotherapy responsiveness after treatment with \> 3 intermediate intensity regimens.
- Advanced Hodgkin's disease beyond PR2 (\>CR3, \>PR3).
- Recent chemotherapy responsiveness
- Multiple Myeloma (\>CR2, \>PR2) or after initial therapy if no prior PR.
- Recent chemotherapy responsiveness
- Recipients will sign informed consent approved by the Committee on the Use of Human Subjects at the University of Minnesota.
Exclusion
- No available histocompatible related donor; 2nd bone marrow transplant (BMT), HIV-1 positive; active uncontrolled infection; or resistant malignancy.
Key Trial Info
Start Date :
October 6 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00612716
Start Date
October 6 1999
End Date
December 15 2019
Last Update
December 9 2020
Active Locations (1)
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1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455