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CBA Versus FBA Conditioning Followed by Haploidentical Allogeneic HSCT in Treatment of High Risk and Refractory AML

NCT03384225 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-10-12

No results posted yet for this study

Summary

Aim: To evaluated if cladribine based conditioning (CBA) could decrease relapse after haploidentical allogeneic HSCT in high risk and refractory AML patients as compared with fludarabine based conditioning regimen(FBA).

Study design: open-labed, prospective, multicenter, randomized control study Number of subjects: 60 each group

Treatment:

CBA group: CBA as HSCT conditioning which including cladribine 5mg/m2 day

-6 to day -2 , busulfan(iv) 3.2mg/kg day-6 to day -3 and cytarabine 2g/m2 day-6 to day -2. FBA group: FBA as HSCT conditioning which including fludarabine 30mg/m2 day -6 to day -2, busulfan(iv) 3.2mg/kg day-6 to day -3 and cytarabine 2g/m2 day-6 to day -2.

Conditions

  • High Risk Acute Myeloid Leukemia
  • Allogeneic Hematopoeitic Stem Cell Transplantation

Interventions

DRUG

Cladribine

DRUG

Fludarabine

DRUG

Busulfan

DRUG

Cytarabine

Sponsors & Collaborators

  • Changhai Hospital

    collaborator OTHER

  • Xiangya Hospital of Central South University

    collaborator OTHER

  • Tongji Hospital

    collaborator OTHER

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER

  • Chengdu PLA General Hospital

    collaborator OTHER

  • Tang-Du Hospital

    collaborator OTHER

  • Fujian Medical University Union Hospital

    collaborator OTHER

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Chun Wang, M.D.,Ph. D. · Shanghai General Hospital, Shanghai Jiaotong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-01
Primary Completion
2022-07-31
Completion
2022-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03384225 on ClinicalTrials.gov