Reduced Intensity, Partially HLA Mismatched BMT to Treat Hematologic Malignancies (NCT01203722) | Clinical Trial Compass
CompletedPhase 1/2
Reduced Intensity, Partially HLA Mismatched BMT to Treat Hematologic Malignancies
United States87 participantsStarted 2010-09
Plain-language summary
If transplantation using mismatched unrelated donors or non-first-degree relatives could be performed with an acceptable toxicity profile, an important unmet need would be served. Towards this goal, the current study extends our platform of nonmyeloablative, partially HLA-mismatched bone marrow transplant (BMT) and Peripheral Blood Stem Cell Transplant (PBSCT) to the use of such donors, investigating up to several postgrafting immunosuppression regimens that incorporate high-dose Cy. Of central interest is the incorporation of sirolimus into this postgrafting immunosuppression regimen.
The primary goal for phase 1 is to identify a transplant regimen associated with acceptable rates of severe acute GVHD and NRM by Day 100 and for phase 2 estimate the 6-month probability of survival without having had acute grade III- IV GVHD or graft failure.
Who can participate
Age range6 Months – 75 Years
SexALL
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Inclusion criteria
✓. Patient age 0.5-75 years
✓. Absence of a suitable related or unrelated bone marrow donor who is molecularly matched at HLA-A, B, Cw, DRB1, and DQB1.
✓. Absence of a suitable partially HLA-mismatched (haploidentical), first-degree related donor. Donors who are homozygous for the CCR5delta32 polymorphism are given preference.
✓. Eligible diagnoses:
✓. Relapsed or refractory acute leukemia in second or subsequent remission, with remission defined as \<5% bone marrow blasts morphologically
✓. Poor-risk acute leukemia in first remission, with remission defined as \<5% bone marrow blasts morphologically:
✓. MDS with at least one of the following poor-risk features:
✓. Interferon- or imatinib-refractory CML in first chronic phase, or non-blast crisis CML beyond first chronic phase.
Exclusion criteria
✕. Potential donors consist of:
What they're measuring
1
Number of Participants Who Have Severe Acute Graft-versus-host-disease (GVHD)
Timeframe: Study Day 100
2
Number of Participants Who Have Transplant-related Nonrelapse Mortality (NRM)
Timeframe: Study Day 100
3
6-month Probability of Survival as Assessed by Absence of Grade III-IV GVHD or Evidence of Graft Failure.
Timeframe: 6 months
Trial details
NCT IDNCT01203722
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
✕. The donor and recipient must be identical at at least 5 HLA alleles based on high resolution typing of HLA-A, -B, -Cw, -DRB1, and -DQB1, with at least one allele matched for a HLA class I gene (HLA-A, -B, or -Cw) and at least one allele matched for a class II gene (HLA-DRB1 or -DQB1).
✕. Meets institutional selection criteria and medically fit to donate. 4 . Lack of recipient anti-donor HLA antibody. Note: In some instances, low level, non-cytotoxic HLA specific antibodies may be permissible if they are found to be at a level well below that detectable by flow cytometry. This will be decided on a case-by-case basis by the PI and one of the immunogenetics directors. Pheresis to reduce anti-HLA antibodies is permissible; however eligibility to proceed with the transplant regimen would be contingent upon the result.