Fludarabine/Busulfan and Cyclophosphamide Conditioning for Adult Lymphoid Malignancies

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 2

Conditions: Lymphoid Malignancies

Treatments: Drug: FLu-Bu-Cy

Study type: Interventional

Funder types: Other

Identifiers

NCT01435447

RJH-ALL-2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

FLu-Bu-Cy

Experimental group

Description:

Patients received Fludarabine and iv Busulfan and post-infusion Cyclophosphamide as conditioning

Treatment:

Drug: FLu-Bu-Cy