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Nonmyeloablative HSCT for High-Risk Hematologic Malignancies
NCT00049504Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2002
- Primary completion
- Mar 2011
- Countries
- 1
- Sponsor
- Fred Hutchinson Cancer Center
- Modality
- Orthosteric Ligands, Metabolically Activated Prodrugs
- Conditions
- hematologic malignancy
01
Overview
Phase 2, open-label, single-arm trial of cyclophosphamide, fludarabine, tacrolimus + Wuzhi capsule and mycophenolate mofetil in hematologic malignancy, sponsored by Fred Hutchinson Cancer Center. Primary endpoints: Donor Engraftment (Chimerism), Incidence of Grades III-IV Acute Graft-Versus-Host Disease up to 200 days and 1 more. Started Jan 2002; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Treatment (nonmyeloablative HSCT)
Patients receive nonmyeloablative conditioning, haploidentical BMT, and post-transplant immunosuppression.
03
Who it enrols
Patients with high-risk hematologic malignancies (including CML, AML, ALL, MDS, MM, CLL, NHL, HD) who are eligible for a nonmyeloablative HSCT with an HLA-haploidentical donor. Patients must have adequate organ function and performance status, and must not have active serious infections or CNS involvement refractory to intrathecal chemotherapy.
04
Endpoints
Primary
Donor Engraftment (Chimerism)
Incidence of Grades III-IV Acute Graft-Versus-Host Disease
Non-relapse-related Mortality
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