At a glance
ClinicalIndex Comparison Record- ✓AML in first or second morphologic complete remission
- ✓CR achieved after no more than 2 cycles of induction/re-induction chemotherapy
- ✓≤6 months from CR documentation to transplant for first CR; ≤3 months for second CR
- ✓6/6 HLA-matched sibling donor (A, B, DRB1 match required; HLA-C typed but not included in algorithm)
- ✕M3-AML (acute promyelocytic leukemia) in first CR
- ✕M4Eo-AML with inv(16) in first CR
- ✕AML with t(8;21) in first CR
- ✕Acute leukemia from blast transformation of prior CML or myeloproliferative disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Single Arm Trial of HLA-Matched Transplants, CD34+ Enriched, T-Cell Depleted Peripheral Blood Stem Cells Isolated by CliniMACS System in the Treatment of Patients With AML in 1st or 2nd Morphologic Complete Remission (BMTCTN0303)
In Brief
A Phase 2 clinical trial evaluating CD34+ selection with CliniMACS device for Leukemia, Myelocytic, Acute. Completed, enrolled 47 participants across 8 sites.
Detailed Summary
This study is a single arm Phase II, multicenter trial. It is designed to determine whether the anticipated endpoints for a T cell depleted transplant arm of a planned prospective randomized trial comparing T cell depleted and unmodified hematopoietic allografts are likely to be achieved in a multicenter study conducted by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN or Network). The study population is patients with acute myeloid leukemia (AML) in first or second morphologic complete remission. The enrollment is 45 patients. Based on published results of unmodified transplants from HLA-matched siblings applied to patients with AML in first or second morphologic complete remission, a significant improvement in results with a graft modified as specified in this protocol would be expected if disease-free survival (DFS) at 6 months was greater than 75%, the true incidence of transplant-related mortality at 1 year was less than 30%, and the DFS rate at 2 years was greater 70% for patients transplanted in first remission and less than 60% for patients transplanted in second remission. Additional secondary endpoints include the following: graft failure rate and incidences of acute grade II-IV and chronic graft-versus-host disease (GVHD). Additionally, the trial will have target specific doses of CD34+ progenitors and CD3+ T cells to be obtained following fractionation with the CliniMACS system. Based on the results of this trial, a Phase III trial comparing T cell depleted peripheral blood stem cell transplants (PBSCT) with unmanipulated bone marrow or unmanipulated PBSCT will be designed.
Study Details
Timeline
Interventions
CD34+ cell selection will be performed according to procedures given in the CliniMACS Users Operating Manual and institutional Standard Operating Procedures (SOPs) in place and validated at the study sites. CliniMACS (Miltenyi device) to target CD34+ \>5 x 10\*6/kg and CD3+ \< 1 x 10\*5/kg