Fludarabine/Busulfan and Cyclophosphamide Conditioning for Adult Lymphoid Malignancies

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fludarabine/Busulfan and Post-infusion Cyclophosphamide as Conditioning for Adult Patients With Lymphoid Malignancies Undergoing Allogeienc Stem Cell Transplantation

Conditions
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Lymphoid Malignancies

Intervention / Treatment
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* Drug: FLu-Bu-Cy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLu-Bu-Cy<br>Patients received Fludarabine and iv Busulfan and post-infusion Cyclophosphamide as conditioning | Drug: FLu-Bu-Cy<br>* 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.<br>* Other names: Study group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute graft versus host disease (GVHD) | d100 incidence of acute GVHD, grade II-IV or grade III-IV | day 100 | 
| chronic GVHD | 3-year incidence of chronic GVHD and extensive cGVHD | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non-relapse mortality (NRM) | estimated 3-year NRM after transplantation (death not due to relapse disease) | 3 years | 
| cumulated incidence of relapse (CIR) | estimated 3-year CIR after transplantation | 3 years | 
| event-free survival (EFS) | estimated 3-year EFS estimated 3-year EFS after transplantation | 3 years | 
| overall survival (OS) | estimated 3-year OS after transplantation | 3 years | 
| GVHD-free, relapse-free survival (GRFS) | estimated 3-year survival for patients without relapse, without III-IV aGVHD and without cGVHD required systemic treatment | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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efficacy, safety, conditioning, fludarabine, busulfan, cyclophosphamide, adult