Lymphoid Malignancies
Conditions
Keywords
efficacy, safety, conditioning, fludarabine, busulfan, cyclophosphamide, adult
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.
Interventions
DRUGFLu-Bu-Cy
Fludarabine at 30mg/m2 daily followed by iv-Busulfan at 3.2mg/kg daily for a total of 4 days from Day-6 to -3 and cyclophosphamide as 60mg/kg daily for 2 days on Day +3 and +4, CSA 3mg/kg starting after D+5.
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| event-free survival (EFS) | 3 years | estimated 3-year EFS estimated 3-year EFS after transplantation |
| non-relapse mortality (NRM) | 3 years | estimated 3-year NRM after transplantation (death not due to relapse disease) |
| 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 |
| cumulated incidence of relapse (CIR) | 3 years | estimated 3-year CIR after transplantation |
Countries
China
Outcome results
None listed