At a glance
ClinicalIndex Comparison Record- ✓Chronic myeloid leukemia in accelerated phase
- ✓Acute myeloid leukemia with high-risk cytogenetics in complete remission 1, or any AML in CR2 or beyond with <5% marrow blasts
- ✓High-risk acute lymphoblastic leukemia, including CR1 with high-risk cytogenetics or CR2+ with <5% marrow blasts
- ✓Myelodysplastic syndromes >intermediate-1 per IPSS after ≥1 prior induction chemotherapy with <5% marrow blasts
- ✕Cross-match positive with donor
- ✕Patients with suitably matched related or unrelated donors (conventional transplant preferred for eligible patients ≤50 years with single HLA-A, -B or DRB1 antigen mismatch)
- ✕Central nervous system involvement with disease refractory to intrathecal chemotherapy
- ✕Active serious infection (e.g., mucormycosis, uncontrolled aspergillosis, tuberculosis)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Nonmyeloablative Hematopoietic Stem Cell Transplantation for Patients With High-Risk Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Phase II Trial of Combined Immunosuppression Before and After Transplantation
In Brief
A Phase 2 clinical trial evaluating cyclophosphamide, fludarabine phosphate, and 9 other interventions for Accelerated Phase Chronic Myelogenous Leukemia and 96 related conditions. Completed, enrolled 53 participants across 1 site.
Detailed Summary
This phase II trial studies how well giving fludarabine phosphate, cyclophosphamide, tacrolimus, mycophenolate mofetil and total-body irradiation together with a donor bone marrow transplant works in treating patients with high-risk hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells by stopping them from dividing or killing them. Giving cyclophosphamide after transplant may also stop the patient's immune system from rejecting the donor's bone marrow stem cells. The donated stem cells may replace the patient's immune system 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 tacrolimus and mycophenolate mofetil after the transplant may stop this from happening
Study Details
Timeline
Interventions
Given IV
Given IV
Given IV or orally
Given orally
Correlative studies
Correlative studies
Correlative studies
Correlative studies
Undergo total-body irradiation
Undergo haploidentical hematopoietic bone marrow transplantation
Undergo haploidentical hematopoietic bone marrow transplantation