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Unrelated BMT with Cyclophosphamide and TBI for Hematologic Malignancies
NCT00002809Phase 2
Key facts
- Status
- Completed
- Start
- Aug 1996
- Primary completion
- Dec 2003
- Countries
- 1
- Sponsor
- Temple University
- Modality
- Small Molecules
- Drugs
- cyclophosphamide
- Conditions
- acute lymphoblastic leukemia (ALL)acute myeloid leukemia (AML)Chronic Myeloid Leukemia (CML)aplastic anemia (AA)paroxysmal nocturnal hemoglobinuria (PNH)
01
Overview
Phase 2, open-label, single-arm trial of cyclophosphamide in acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), Chronic Myeloid Leukemia (CML) and 3 more, sponsored by Temple University. Primary endpoint: Curative potential of high-dose cyclophosphamide and total-body irradiation followed by rescue with bone marrow. Started Aug 1996; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Treatment Arm
Cyclophosphamide + TBI + Unrelated BMT (+/- ATG)
03
Who it enrols
Patients aged 17-60 with specific hematologic malignancies (ALL, AML, CML, MDS) or bone marrow failure states (SAA, PNH) who have an available 8/10 to 10/10 HLA-matched unrelated donor. Patients must have adequate organ function (cardiac, pulmonary, hepatic, renal) and no active infection or HIV.
04
Endpoints
Primary
Curative potential of high-dose cyclophosphamide and total-body irradiation followed by rescue with bone marrow
Secondary
Toxic effects associated with matched unrelated bone marrow transplantation
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