NCT06133556

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for phase_2

Timeline
30mo left

Started Nov 2023

Longer than P75 for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Nov 2023Oct 2028

First Submitted

Initial submission to the registry

September 8, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 15, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

November 24, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2028

Last Updated

November 15, 2023

Status Verified

September 1, 2023

Enrollment Period

4.9 years

First QC Date

September 8, 2023

Last Update Submit

November 13, 2023

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Relapse Free Survival

    The AML relapse free survival post-HSCT

    3 year post-HSCT

Secondary Outcomes (5)

  • Overall Survival

    3 year post-HSCT

  • cumulative incidence relapse rate

    3 year post-HSCT

  • Non-relapse mortality

    3 year post-HSCT

  • toxicity of conditioning regimen

    24w post-HSCT

  • Immune reconstitution post-HSCT

    24w post-HSCT

Study Arms (2)

control arm

ACTIVE COMPARATOR

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

MCBC group

EXPERIMENTAL

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

Interventions

MCBC regimenDRUG

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

Also known as: experiment group
MCBC group
Bu/Cy regimenDRUG

control group, the standard conditioning regimen Busulfan/Cyclophosphamide

Also known as: classic group
control arm

Eligibility Criteria

AgeUp to 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2023

First Posted

November 15, 2023

Study Start

November 24, 2023

Primary Completion (Estimated)

October 20, 2028

Study Completion (Estimated)

October 20, 2028

Last Updated

November 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share