Phase 2
Completed N=55
Haploidentical Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancer
leukemia · Non-Hodgkin's Lymphoma · Angioimmunoblastic T-cell lymphoma · Childhood Myelodysplastic Syndromes
Source: ClinicalTrials.gov NCT00049504 ↗
Enrolled (actual)
55
Serious AEs
20.0%
Results posted
May 2017
Primary outcomePrimary: Donor Engraftment (Chimerism) — 34 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Donor Engraftment (Chimerism) |
34 | — |
| PRIMARY Incidence of Grades III-IV Acute GVHD |
4 | — |
| PRIMARY Non-relapse-related Mortality |
12 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic myeloid leukemia (CML) in accelerated phase (AP)
- Acute myeloid leukemia (AML) with high-risk cytogenetics [del(5q)/-5, del(7q)/-7, abnormal 3q, 9q, 11q, 20q, 21q, 17p, t(6:9), t(9;22), complex karyotypes (>= 3 abnormalities)] in complete remission (CR)1
- AML >= CR2; patients should have 4 wk to achieve CR1; >= CR2 (patients should have int-1 per IPSS) after >= 1 prior cycle of induction chemotherapy; should have 3 mg/dL or symptomatic biliary disease
- Human immunodeficiency virus (HIV)-positive patients
- Women of childbearing potential who are pregnant (beta-HCG+) or breast feeding
- Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant
- Life expectancy severely limited by diseases other than malignancy
- DONOR: Donor-recipient pairs in which the HLA-mismatch is only in the HVG direction
- DONOR: Cross-match positive with recipient
Data sourced from ClinicalTrials.gov (NCT00049504). 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.