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.
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
- Are there results?
- Not yet: the study is under way
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;
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- 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）;
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- 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.
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
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.
- 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 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.
- 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.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07644481
- Acronym / sponsor ID
- IIT2026038
- Conditions
- AML (Acute Myelogenous Leukemia), Allogeneic Hematopoietic Stem Cell Transplantation Recipient
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Planned to enroll adult patients with acute myeloid leukemia (AML) who achieve first complete remiss | Experimental | Drug: CloB2M (Clofarabine Combined With Busulfan and Melphalan) Conditioning Regimen |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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:
- 4.Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0-2;
- 5.Estimated survival time more than 6 months;
Key exclusion criteria (12 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CloB2M (Clofarabine Combined With Busulfan and Melphalan) Conditioning RegimenCloB2M (Clofarabine Combined With Busulfan and Melphalan) Conditioning Regimen | Drug | Planned to enroll adult patients with acute myeloid leukemia (AML) who achieve first complete remiss |
Primary outcome
2-year Overall Survival（OS）rate
Time frame: 2 years.
8 secondary outcomes
1-year Overall Survival（OS）rate
Time frame: 1 year
1-year Relapse-Free Survival(RFS) rate,2-years Relapse-Free Survival(RFS) rate
Time frame: 1-year,2-years
Day 100 non-relapse mortality (NRM) rate after transplantation
Time frame: as the non-relapse mortality at Day 100 post-transplantation.
2-year cumulative incidence of relapse (CIR) after transplantation
Time frame: 2-year
Minimal Residual Disease(MRD) negative conversion rate
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: From start of treatment to 2 years post-treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erlie Jiang (+86-15122538106, jiangerlie@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year Overall Survival（OS）rate (time frame: 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.