Phase 2
Completed N=6
Donor Stem Cell Transplant in Treating Patients With Previously Treated Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia
Source: ClinicalTrials.gov NCT00612716 ↗Enrolled (actual)
6
Serious AEs
50.0%
Results posted
Dec 2020
Primary outcomePrimary: Number of Participants With Engraftment Failure — 1 Participants
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 immune system from rejecting the donor's stem cells. The donated stem cells from bone marrow or umbilical cord blood may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving methotrexate and cyclosporine after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in treating patients with previously treated lymphoma, multiple myeloma, or chronic lymphocytic leukemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Engraftment Failure |
1 | — |
| PRIMARY Number of Participants With Neutrophil Engraftment |
5 | — |
| PRIMARY Number of Participants With Platelet Engraftment |
2 | — |
| PRIMARY Number of Participants With Grade 3-4 Acute Graft-versus-host Disease |
3 | — |
| PRIMARY Number of Participants With Persistence Disease |
1 | — |
| PRIMARY Number of Participants With Relapse of Malignancy |
1 | — |
| PRIMARY Number of Participants With 1 Year Overall Survival |
2 | — |
| PRIMARY Number of Participants With 2 Year Overall Survival |
1 | — |
| SECONDARY Number of Participants With of Chronic GVHD. |
— | — |
Eligibility Criteria
Inclusion Criteria
- Donors will be 90% and will have:
- Creatinine 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 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 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 stage III at diagnosis; after any progression even if localized (stage I, II) at diagnosis with prior response duration 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 Criteria
- No available histocompatible related donor; 2nd bone marrow transplant (BMT), HIV-1 positive; active uncontrolled infection; or resistant malignancy.
Data sourced from ClinicalTrials.gov (NCT00612716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.