drugset / Trial / NCT01435447

Fludarabine/Busulfan and Cyclophosphamide Conditioning for Adult Lymphoid Malignancies

NCT01435447 ↗

Phase 2 Completed 31 enrolled Shanghai Jiao Tong University School of Medicine
NaSingle-groupOpen-labelTreatment

Summary

Allogeneic stem cell transplantation is potential curative therapy for adult lymphoid malignancies. Based on our previous study, the condition with iv-busulfan (iv-BU) and cyclophosphamide (CTX) is feasible with low toxicity and transplantation mortality and long-term survival is comparable to most data reported with slightly higher relapse rate particularly for patients in CR2. In this study, the investigators aim to further improve the conditioning with Fludarabine + iv-BU and to use CTX after stem cell transfusion as consolidation for lymphoid malignancies and graft-versus-host disease (GVHD) prophylaxis.

Timeline

Start
2011-04
Primary completion
2018-06-30
Completion
2018-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule 3.2 mg/kg Intravenous
Subject Cyclophosphamide Other / unclassified 60 mg/kg —
Subject Fludarabine Small molecule 30 mg/m2 —
Background CSA Unknown 3 mg/kg —

Indications