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Completed

NCT Number: NCT01435447

Fludarabine/Busulfan and Cyclophosphamide Conditioning for Adult Lymphoid Malignancies

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.

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Key information

Conditions

Lymphoid Malignancies

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Blood and Marrow Transplantation Center, Rui Jin Hospital

Shanghai, Shanghai Municipality, 200025, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Study group

Primary outcomes

  1. acute graft versus host disease (GVHD)

    Time frame: day 100

    d100 incidence of acute GVHD, grade II-IV or grade III-IV

  2. chronic GVHD

    Time frame: 3 years

    3-year incidence of chronic GVHD and extensive cGVHD

Secondary outcomes

  1. non-relapse mortality (NRM)

    Time frame: 3 years

    estimated 3-year NRM after transplantation (death not due to relapse disease)

  2. cumulated incidence of relapse (CIR)

    Time frame: 3 years

    estimated 3-year CIR after transplantation

  3. event-free survival (EFS)

    Time frame: 3 years

    estimated 3-year EFS estimated 3-year EFS after transplantation

  4. overall survival (OS)

    Time frame: 3 years

    estimated 3-year OS after transplantation

  5. 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

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Sep 16, 2011
Registry last updated
Nov 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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