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Pentostatin and Low-Dose TBI for Stem Cell Transplant in Hematological Cancer
NCT00816413Phase 2
Key facts
- Status
- Withdrawn
- Start
- Sep 2008
- Primary completion
- Feb 2010
- Sponsor
- University of Nebraska
- Modality
- Orthosteric Ligands, Metabolically Activated Prodrugs
- Drugs
- pentostatin
- Conditions
- acute myeloid leukemia (AML)acute lymphoblastic leukemia (ALL)myelodysplastic syndrome (MDS)chronic myelogenous leukemia (CML)mantle cell lymphoma (MCL)
01
Overview
Phase 2, open-label, single-arm trial of pentostatin in acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS) and 4 more, sponsored by University of Nebraska. Primary endpoints: Severe transplant-related toxicity, Stable donor engraftment at day 70 and 1 more. Planned start Sep 2008; status: withdrawn.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Experimental Arm
Pentostatin + TBI conditioning followed by PBSCT and GVHD prophylaxis
03
Endpoints
Primary
Severe transplant-related toxicity
Stable donor engraftment
Mortality
Secondary
Incidence of grade III-IV acute graft-versus-host disease
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