AML (Acute Myelogenous Leukemia)NCT07644481

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

A study testing CloB2M (Clofarabine Combined With Busulfan and Melphalan) Conditioning Regimen in people with AML (Acute Myelogenous Leukemia) and Allogeneic Hematopoietic Stem Cell Transplantation Recipient, run by Institute of Hematology & Blood Diseases Hospital, China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

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). Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: AML (Acute Myelogenous Leukemia), Allogeneic Hematopoietic Stem Cell Transplantation Recipient
What is being tested?: CloB2M (Clofarabine Combined With Busulfan and Melphalan) Conditioning Regimen
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: 20 Jul 2026to 31 Dec 2029
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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;
3.Meeting any of the following criteria upon clinical evaluation:
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;
4.Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0-2;

Show all 16Show fewer

5.Estimated survival time more than 6 months;
6.Meeting the indications for allogeneic hematopoietic stem cell transplantation (allo-HSCT), and having an eligible hematopoietic stem cell donor with qualified physical examination, including HLA-matched sibling donor, unrelated donor (high-resolution HLA 9-10/10 matched) or haploidentical related donor;
7.Adequate major organ function meeting the following criteria:
Total bilirubin (TBIL) ≤ 2 times the upper limit of normal (ULN); Alanine transaminase (ALT) and Aspartate transaminase (AST) ≤ 3 × ULN;
Serum creatinine (Cr) ≤ 1.5 × ULN, or estimated creatinine clearance ≥ 50 mL/min calculated by the Cockcroft-Gault glomerular filtration formula;
Coagulation function meeting the following standards: Prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN (without anticoagulant therapy);
Electrocardiogram showing no acute myocardial infarction or severe arrhythmia; Echocardiography with left ventricular ejection fraction (LVEF) ≥ 50%, without significant cardiomegaly, valvular heart disease or congenital heart disease;
Pulmonary function tests: FEV1, FVC and DLCO ≥ 60% of predicted value;
8.Willing to provide available diagnostic evidence or undergo bone marrow aspiration and biopsy prior to study treatment, and agree to receive regular bone marrow aspiration and biopsy after study treatment;
9.Must sign the informed consent form prior to study enrollment, signed by the patient personally or immediate family members. If signature by the patient is deemed detrimental to disease treatment based on clinical condition assessment, the informed consent shall be signed by the legal guardian or immediate family member of the patient.

Who cannot join

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);
5. Uncontrolled systemic diseases (such as uncontrolled hypertension, diabetes mellitus, etc.);
6.Active hepatitis B or hepatitis C infection:（Hepatitis B virus surface antigen positive, hepatitis B core antibody positive with HBV-DNA level exceeding 1×103 copies/mL;Hepatitis C virus RNA level exceeding 1×10 3 copies/mL）;

Show all 12Show fewer

7.Uncontrolled ongoing infection, or patients requiring mechanical ventilation or with hemodynamic instability;
8.Patients with psychiatric disorders or other medical conditions who are unable to comply with study treatment and monitoring requirements;
9.Participation in another ongoing clinical trial, or enrollment in any other drug clinical trial within the past 1 month;
10.Pregnant or lactating females, and patients who refuse to use effective contraception during the study period;
11.Patients who are unable to understand the trial protocol, adhere to medication instructions, or refuse to sign the informed consent form;
12.Patients deemed ineligible for enrollment by the investigator.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Erlie Jiang contact

+86-15122538106

jiangerlie@ihcams.ac.cn

Xiaoyu Zhang contact

+86-18202579691

zhangxiaoyu@ihcams.ac.cn

About this study

Official title: 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: An Open-Label, Prospective, Single-Arm Clinical Trial

Conditions: AML (Acute Myelogenous Leukemia), Allogeneic Hematopoietic Stem Cell Transplantation Recipient
Being tested: CloB2M (Clofarabine Combined With Busulfan and Melphalan) Conditioning Regimen
Medical subject headings: Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT07644481
Study group	Role	What they receive
Planned to enroll adult patients with acute myeloid leukemia (AML) who achieve first complete remiss	Experimental	Not described Receives: Drug: CloB2M (Clofarabine Combined With Busulfan and Melphalan) Conditioning Regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

2-year Overall Survival（OS）rate
Measured: 2 years.

Secondary outcomes (8)

1-year Overall Survival（OS）rate
Measured: 1 year
1-year Relapse-Free Survival(RFS) rate,2-years Relapse-Free Survival(RFS) rate
Measured: 1-year,2-years
Day 100 non-relapse mortality (NRM) rate after transplantation
Measured: as the non-relapse mortality at Day 100 post-transplantation.
2-year cumulative incidence of relapse (CIR) after transplantation
Measured: 2-year
Minimal Residual Disease(MRD) negative conversion rate
Measured: Bone marrow MRD levels are monitored at 1, 3, 6, 9 and 12 months after hematopoietic stem cell transplantation.
Time to Absolute Neutrophil Count(ANC) engraftment and time to Platelet Count(PLT) engraftment (hematopoietic reconstitution time)
Measured: Time to ANC engraftment is defined as the first day of sustained absolute neutrophil count ≥ 0.5×10⁹/L for three consecutive days after transplantation. Time to PLT engraftment is defined as the first day of sustained platelet count ≥ 20×10⁹/L for seven
Incidence of Graft-versus-Host Disease(GVHD)
Measured: The incidences of acute graft-versus-host disease (aGVHD) and severe (Grade III-IV) aGVHD within 100 days after hematopoietic stem cell transplantation, as well as chronic graft-versus-host disease (cGVHD) within 2 years after transplantation.
The severity of adverse events and the number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: From start of treatment to 2 years post-treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jul 202631 Dec 2029

First posted12 Jun 2026
Study start20 Jul 2026 (estimated)
Primary completion31 Dec 2029 (estimated)
Study completion31 Dec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AML (Acute Myelogenous Leukemia)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07644481
Sponsor's protocol ID: IIT2026038
Status last verified: Jun 2026
First submitted: 10 May 2026
Last updated: 12 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Erlie Jiang

+86-15122538106

jiangerlie@ihcams.ac.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruitingPhase 2
Cord Blood Transplant in Adults With Blood Cancers
Acute Myelogenous Leukemia (AML), Acute Lymphoblastic Leukemia (ALL)
RecruitingPhase 1
Clinical Trial of WBC100 Capsule in Relapsed/Refractory Acute Myeloid Leukemia
AML (Acute Myelogenous Leukemia, Relapsed Acute Myelogenous Leukemia
Enrolling by invitationObservational study
Forecasting Relapse Outcomes With AlloHeme-based Risk Detection in Post-Allo-HCT AML/MDS Patients (FORWARD)
AML (Acute Myelogenous Leukemia), MDS (Myelodysplastic Syndrome)
RecruitingEarly Phase 1
Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Bone Marrow or Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies
Hematologic Malignancy, Bone Marrow Transplant Rejection
RecruitingObservational study
Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
Hematologic Malignancy, Leukemia

All AML (Acute Myelogenous Leukemia) trials