Fludarabine/Busulfan and Cyclophosphamide Conditioning for Adult Lymphoid Malignancies
- Conditions
- Lymphoid Malignancies
- Interventions
- Drug: FLu-Bu-Cy
- Registration Number
- NCT01435447
- Lead Sponsor
- Shanghai Jiao Tong University School of Medicine
- Brief 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.
- Detailed Description
Patients with adult lymphoid malignancies received conditioning with Fludarabine + iv-BU. The GVHD was consisting of D+3 and D+4 CTX after stem cell transfusion. CSA will be added for all patients after D+5.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- adult acute lymphocytic leukemia in 1st or second remission; lymphoid malignancies in 1st or second remission
- age 16-60 years
- with inform consent
- no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
- HLA matched related (6/6), unrelated donors (at least 8/10) or mismatched related donor (haplo)
- age less than 16 years or over 60 years
- liver function/renal function damage (over 2 X upper normal range)
- with mental disease
- other contraindication of all-HSCT
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FLu-Bu-Cy FLu-Bu-Cy Patients received Fludarabine and iv Busulfan and post-infusion Cyclophosphamide as conditioning
- Primary Outcome Measures
Name Time Method acute graft versus host disease (GVHD) day 100 d100 incidence of acute GVHD, grade II-IV or grade III-IV
chronic GVHD 3 years 3-year incidence of chronic GVHD and extensive cGVHD
- Secondary Outcome Measures
Name Time Method non-relapse mortality (NRM) 3 years estimated 3-year NRM after transplantation (death not due to relapse disease)
cumulated incidence of relapse (CIR) 3 years estimated 3-year CIR after transplantation
event-free survival (EFS) 3 years estimated 3-year EFS estimated 3-year EFS after transplantation
GVHD-free, relapse-free survival (GRFS) 3 years estimated 3-year survival for patients without relapse, without III-IV aGVHD and without cGVHD required systemic treatment
overall survival (OS) 3 years estimated 3-year OS after transplantation
Trial Locations
- Locations (1)
Blood and Marrow Transplantation Center, Rui Jin Hospital
🇨🇳Shanghai, Shanghai, China