Fludarabine/Busulfan and Cyclophosphamide Conditioning for Adult Lymphoid Malignancies

October 31, 2018 updated by: Jiong HU, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Blood and Marrow Transplantation Center, Rui Jin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: FLu-Bu-Cy
Patients received Fludarabine and iv Busulfan and post-infusion Cyclophosphamide as conditioning
Drug: FLu-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.
Other Names:
  • Study group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2011

Primary Completion (ACTUAL)

June 30, 2018

Study Completion (ACTUAL)

October 1, 2018

Study Registration Dates

First Submitted

September 14, 2011

First Submitted That Met QC Criteria

September 15, 2011

First Posted (ESTIMATE)

September 16, 2011

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2018

Last Update Submitted That Met QC Criteria

October 31, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJH-ALL-2011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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