At a glance
ClinicalIndex Comparison Record- ✓Prior allogeneic hematopoietic cell transplantation from HLA-matched related donor (genotypically identical at ≥1 haplotype, phenotypically or genotypically identical at HLA A, B, C, DRB1, DQB1) or unrelated donor (matched at HLA-A, B, C, DRB1, DQB1 by high-resolution typing or single allele disparity allowed)
- ✓<50% donor CD3 peripheral blood chimerism on two consecutive evaluations ≥14 days apart, OR ≥20% absolute decrease in donor CD3 chimerism with second test showing <50% donor CD3 cells
- ✓Stable or persistent disease (no progression compared to pre-transplantation status)
- ✓Tapered to systemic steroid dosage ≤0.25 mg/kg/day
- ✕Current grade II-IV acute GVHD or extensive chronic GVHD
- ✕Karnofsky score <50% (or Lansky score <40 in pediatric patients)
- ✕Evidence of relapse or progression of disease after transplantation
- ✕Prior recipient of cord blood transplant
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pentostatin and Donor Lymphocyte Infusion for Low Donor T-cell Chimerism After Hematopoietic Cell Transplantation - A Multi-center Trial
In Brief
A Phase 2 clinical trial evaluating Cyclosporine, Mycophenolate Mofetil, and 2 other interventions for Acute Lymphoblastic Leukemia and 9 related conditions. Completed, enrolled 36 participants across 5 sites in 2 countries.
Detailed Summary
This phase II trial studies pentostatin and donor lymphocyte infusion in preventing graft rejection in patients who have undergone donor stem cell transplant. Giving pentostatin and an infusion of the donor's T cells (donor lymphocyte infusion) after a donor stem cell transplant may stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells 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 pentostatin before donor lymphocyte infusion may stop this from happening.
Study Details
Timeline
Interventions
Given PO
Given PO
Given IV
Given IV