At a glance
ClinicalIndex Comparison Record- ✓Ph+ ALL or CML-BC with <15% blasts on morphologic marrow evaluation after imatinib, dasatinib, or nilotinib; or complete remission (no detectable Ph+ by morphologic or molecular assays)
- ✓HLA-matched related donor (genotypically identical at least at one haplotype) or unrelated donor (grades 1.0 to 2.1 match, single allele disparity allowed for HLA-A, B, or C only)
- ✓G-CSF mobilized peripheral blood stem cells as HSC source
- ✕CNS involvement with leukemia refractory to intrathecal chemotherapy
- ✕Active non-hematologic malignancies (except non-melanoma skin cancers)
- ✕History of non-hematologic malignancies in complete remission <5 years with >20% recurrence risk
- ✕HIV-positive status
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Allogeneic Nonmyeloablative Hematopoietic Stem Cell Transplant for Patients With BCR-ABL Tyrosine Kinase Inhibitor Responsive Ph+ Acute Leukemia ? A Multi-center Trial
In Brief
A Phase 2 clinical trial evaluating Cyclosporine, Dasatinib, and 8 other interventions for Adult Acute Lymphoblastic Leukemia in Remission and 9 related conditions. Completed, enrolled 28 participants across 3 sites.
Detailed Summary
This phase II trial is studying how well fludarabine phosphate and total-body irradiation followed by donor peripheral blood stem cell transplant work in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous treatment with imatinib mesylate, dasatinib, or nilotinib. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.
Study Details
Timeline
Interventions
Given IV or PO
Given PO
Given IV
Given PO
Given PO
Given PO
Undergo nonmyeloablative allogeneic PBSC transplantation
Undergo allogeneic PBSC transplantation
Given IV
Undergo TBI