Conditioning Regimen Containing Melphalan and Cladribine for Refractory / Relapsed AML

Institute of Hematology & Blood Diseases Hospital, China (Other)
Overall Status
Not yet recruiting ID

Study Details

Study Description

Brief Summary

This project is a prospective, multicenter, randomized controlled clinical study. The subjects were refractory / relapsed AML patients aged ≤ 60 years diagnosed by bone marrow cell morphology, immunology, genetics and therapeutic efficacy evaluation. The classical Bu / Cy scheme or MCBC scheme was used for pretreatment. The primary endpoint of the study was the 3-year recurrence-free survival rate after allogeneic hematopoietic stem cell transplantation, and the secondary endpoints were 3-year overall survival rate, recurrence rate, treatment-related mortality, and pretreatment-related toxicity.

Condition or Disease Intervention/Treatment Phase
  • Drug: MCBC regimen
  • Drug: Bu/Cy regimen
Phase 2

Study Design

Study Type:
Anticipated Enrollment :
237 participants
Intervention Model:
Parallel Assignment
Single (Investigator)
Primary Purpose:
Official Title:
Conditioning Regimen Containing Melphalan and Cladribine for Refractory / Relapsed AML
Anticipated Study Start Date :
Nov 24, 2023
Anticipated Primary Completion Date :
Oct 20, 2028
Anticipated Study Completion Date :
Oct 20, 2028

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: control arm

Busulfan/Cyclophosphamide, "standard" conditioning regimen as a control group. including Bu3.2mg/kg -5~-3d; Cy 80mg/kg,-2~-1d。 or alternative Bu/Cy regimen, Bu3.2mg/kg -9~-7d;Flu 30mg/m2 -6~-4d;Ara-C 2g/m2 -6~-4d;Cy 80mg/kg -3~-2d。

Drug: Bu/Cy regimen
control group, the standard conditioning regimen Busulfan/Cyclophosphamide
Other Names:
  • classic group
  • Experimental: MCBC group

    using MCBC as conditioning regimen, Mel 60mg/ m2 -9~-8d, Cladribine 5 mg/m2 -9~-5d, Bu3.2mg/kg -5~-3d; Cy 30mg/kg -2~-1 d

    Drug: MCBC regimen
    using MCBC as conditioning regimen, Mel 60mg/ m2 -9~-8d, Cladribine 5 mg/m2 -9~-5d, Bu3.2mg/kg -5~-3d; Cy 30mg/kg -2~-1 d
    Other Names:
  • experiment group
  • Outcome Measures

    Primary Outcome Measures

    1. Relapse Free Survival [3 year post-HSCT]

      The AML relapse free survival post-HSCT

    Secondary Outcome Measures

    1. Overall Survival [3 year post-HSCT]

      The overall survival post-HSCT

    2. cumulative incidence relapse rate [3 year post-HSCT]

      cumulative incidence relapse rate post-HSCT

    3. Non-relapse mortality [3 year post-HSCT]

      Non-relapse mortality post-HSCT

    4. toxicity of conditioning regimen [24w post-HSCT]

      Adverse events as assessed by CTCAE to evaluate conditioning related toxicity

    5. Immune reconstitution post-HSCT [24w post-HSCT]

      Using lymphocyte subset panel to assess immune recovery post-HSCT

    Eligibility Criteria


    Ages Eligible for Study:
    N/A to 60 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • Refractory / relapsed AML.

    • Patients with a HLA matched related or unrelated donor (9~10/10) or haplo-identical related donor, plan to receive HSCT.

    • Age ≤ 60 years old, men and women are not limited.

    • The Eastern Oncology Collaborative Group Physical Status Assessment ( ECOG-PS ) was 0-2 points.

    • Informed consent must be signed before the start of the study procedure. Informed consent must be signed by the patient or his or her immediate family members who are 18 years of age or older ; informed consent was signed by the legal guardian for children and adolescent patients under 18 years old. Considering the patient 's condition, if the patient 's signature is not conducive to the treatment of the disease, the informed consent is signed by the legal guardian or the patient 's immediate family.

    Exclusion Criteria:
    • Have a history of cancer and have received any treatment for this tumor in the past 3 years. But remove superficial bladder cancer, skin basal cells or squamous cell carcinoma, cervical epithelium. Intraepithelial neoplasia ( CIN ) or prostatic intraepithelial neoplasia ( PIN ).

    • MPAL.

    • It is known that the serological reaction of HIV or active hepatitis C virus is positive.

    • The inability to cooperate with the requirements of research, treatment and monitoring due to mental illness or other conditions.

    • Pregnant patients or patients who could not take appropriate contraceptive measures during treatment.

    • Previously received hematopoietic stem cell transplantation.

    • Active heart disease, defined as one or more of the following :

    1. ) Uncontrolled or symptomatic angina history.

    2. ) Myocardial infarction less than 6 months away from the study.

    3. ) Have a history of arrhythmia requiring drug treatment or severe clinical symptoms.

    4. ) Uncontrolled or symptomatic congestive heart failure ( > NYHA class 2 ).

    5. ) The ejection fraction is lower than the lower limit of the normal range.

    • Researchers evaluated that is not suitable for the group.

    Contacts and Locations


    No locations specified.

    Sponsors and Collaborators

    • Institute of Hematology & Blood Diseases Hospital, China


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Institute of Hematology & Blood Diseases Hospital, China Identifier:
    Other Study ID Numbers:
    • IIT2023023-EC-2
    First Posted:
    Nov 15, 2023
    Last Update Posted:
    Nov 15, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:

    Study Results

    No Results Posted as of Nov 15, 2023