Fludarabine/Busulfan and Cyclophosphamide Conditioning for Adult Lymphoid Malignancies

NCT01435447 | Completed Phase 2

• 1 other identifier: RJH-ALL-2011
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoid Malignancies

Keywords

efficacy; safety; conditioning; fludarabine; busulfan; cyclophosphamide; adult

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• non-relapse mortality (NRM)

  3 years

• cumulated incidence of relapse (CIR)

  3 years

• event-free survival (EFS)

  3 years

• overall survival (OS)

  3 years

• GVHD-free, relapse-free survival (GRFS)

  3 years

Study Arms (1)

FLu-Bu-Cy

EXPERIMENTAL

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

Drug: FLu-Bu-Cy

Interventions

FLu-Bu-Cy DRUG

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.

Also known as: Study group

FLu-Bu-Cy

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Blood and Marrow Transplantation Center, Rui Jin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Study Officials

• Jiong Hu, m.D.

  Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Blood and Marrow Transplantation Center, Rui Jin Hospital

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 16, 2011
• Study Start: April 1, 2011
• Primary Completion: June 30, 2018
• Study Completion: October 1, 2018
• Last Updated: November 2, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)