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Haplo-identical PBSC + Cord Blood Transplant for High Risk Hematological Malignancies
NCT01682226Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2012
- Primary completion
- Jan 2021
- Countries
- 1
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Modality
- Stem Cell Therapies
- Conditions
- leukemiamyelodysplastic syndrome (MDS)lymphoma
01
Overview
Phase 2, open-label trial of haploidentical donor CD34+ cells in leukemia, myelodysplastic syndrome (MDS) and lymphoma (2 arms), sponsored by Memorial Sloan Kettering Cancer Center. Primary endpoint: Percent of Engrafted Participants With Successful Neutrophil Recovery at Day 45. Started Sep 2012; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Standard Risk Group
Myeloablative conditioning with Fludarabine, Cyclophosphamide, Thiotepa, TBI followed by CBT and haploidentical PBSC.
High Risk Group
Myeloablative conditioning with Fludarabine, Cyclophosphamide, TBI followed by CBT and haploidentical PBSC.
03
Who it enrols
Patients aged 2-70 with high-risk hematological malignancies lacking a suitably matched unrelated donor, with adequate organ function and performance status.
04
Endpoints
Primary
Percent of Engrafted Participants With Successful Neutrophil Recovery
Secondary
Overall Survival
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