Conditioning Regimen Containing Melphalan and Cladribine for Refractory / Relapsed AML

Acute Myeloid Leukemia Clinical Trial

Official title:

Conditioning Regimen Containing Melphalan and Cladribine for Refractory / Relapsed AML

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06133556
• Other study ID #: IIT2023023-EC-2
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 24, 2023
• Est. completion date: October 20, 2028

Study information

• Verified date: September 2023
• Source: Institute of Hematology & Blood Diseases Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 237
• Est. completion date: October 20, 2028
• Est. primary completion date: October 20, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia

Intervention

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
• Bu/Cy regimen
control group, the standard conditioning regimen Busulfan/Cyclophosphamide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse Free Survival	The AML relapse free survival post-HSCT	3 year post-HSCT
Secondary	Overall Survival	The overall survival post-HSCT	3 year post-HSCT
Secondary	cumulative incidence relapse rate	cumulative incidence relapse rate post-HSCT	3 year post-HSCT
Secondary	Non-relapse mortality	Non-relapse mortality post-HSCT	3 year post-HSCT
Secondary	toxicity of conditioning regimen	Adverse events as assessed by CTCAE to evaluate conditioning related toxicity	24w post-HSCT
Secondary	Immune reconstitution post-HSCT	Using lymphocyte subset panel to assess immune recovery post-HSCT	24w post-HSCT