Conditioning Regimen Containing Melphalan and Cladribine for Refractory / Relapsed AML

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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

Up to 60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

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 :

) Uncontrolled or symptomatic angina history.
) Myocardial infarction less than 6 months away from the study.
) Have a history of arrhythmia requiring drug treatment or severe clinical symptoms.
) Uncontrolled or symptomatic congestive heart failure ( > NYHA class 2 ).
) The ejection fraction is lower than the lower limit of the normal range.
Researchers evaluated that is not suitable for the group.

Treatment and study plan

MCBC regimen

Drug

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

Bu/Cy regimen

Drug

control group, the standard conditioning regimen Busulfan/Cyclophosphamide

Other names: classic group

Primary outcomes

Relapse Free Survival

Time frame: 3 year post-HSCT

The AML relapse free survival post-HSCT

Secondary outcomes

Overall Survival

Time frame: 3 year post-HSCT

The overall survival post-HSCT
cumulative incidence relapse rate

Time frame: 3 year post-HSCT

cumulative incidence relapse rate post-HSCT
Non-relapse mortality

Time frame: 3 year post-HSCT

Non-relapse mortality post-HSCT
toxicity of conditioning regimen

Time frame: 24w post-HSCT

Adverse events as assessed by CTCAE to evaluate conditioning related toxicity
Immune reconstitution post-HSCT

Time frame: 24w post-HSCT

Using lymphocyte subset panel to assess immune recovery post-HSCT

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2028
Study completion: 2028
First posted: Nov 15, 2023
Registry last updated: Nov 15, 2023

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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