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Efficacy and Safety of the CloB2M (Clofarabine Combined With Busulfan and Melphalan) Conditioning Regimen in Allogeneic Hematopoietic Stem Cell Transplantation for Adult Patients With Acute Myeloid Leukemia in First Complete Remission

ConditionsAML (Acute Myelogenous Leukemia)Allogeneic Hematopoietic Stem Cell Transplantation Recipient
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

This is a single-center, prospective, exploratory clinical study. It plans to enroll 30 adult patients with acute myeloid leukemia (AML) who have achieved first complete remission (CR1) after induction therapy and meet the indications for allogeneic hematopoietic stem cell transplantation (allo-HSCT). The aim is to evaluate the efficacy and safety of allo-HSCT following conditioning regimens with clofarabine, busulfan and melphalan.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1.Aged from 18 to 60 years inclusive, with no restriction on gender;

2.Patients diagnosed with acute myeloid leukemia (AML, excluding acute promyelocytic leukemia, APL) by bone marrow morphological, immunological and genetic examinations according to the 2022 World Health Organization (WHO) classification, who have achieved first complete remission (CR1) after induction therapy;

AML classified as intermediate or adverse genetic risk according to the 2022 ELN genetic risk stratification;

AML with positive measurable residual disease (MRD) before transplantation;

Disqualifiers

1.Refractory/relapsed AML;

2.Known hypersensitivity to any drugs in the conditioning regimen or their excipients;

3.Major surgery within the past 4 weeks (excluding diagnostic surgical procedures);

4.History of or concurrent other malignant tumors (excluding well-controlled non-melanoma basal cell carcinoma of the skin, breast/cervical carcinoma in situ, and other malignancies well controlled without treatment for more than five years);

Trial design

Design model

Single group

Treatments tested in this trial

  • CloB2M (Clofarabine Combined With Busulfan and Melphalan) Conditioning Regimen

    Drug

    CloB2M (Clofarabine Combined With Busulfan and Melphalan) Conditioning Regimen

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Planned to enroll adult patients with acute myeloid leukemia (AML) who achieve first complete remissExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

2-year Overall Survival（OS）rate

Time frame
2 years.

Secondary outcomes

1

1-year Overall Survival（OS）rate

Time frame
1 year
2

1-year Relapse-Free Survival(RFS) rate,2-years Relapse-Free Survival(RFS) rate

Time frame
1-year,2-years
3

Day 100 non-relapse mortality (NRM) rate after transplantation

Time frame
as the non-relapse mortality at Day 100 post-transplantation.
4

2-year cumulative incidence of relapse (CIR) after transplantation

Time frame
2-year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: