Hematologic DiseasePhase 1MIGHTNCT06809712
Human Leukocyte Antigen (HLA) Mismatched Unrelated Allogeneic Hematopoietic Stem Cell Transplantation
A Phase 1 study testing Busulfan (Busulfex), Cyclophosphamide (CTX) and Fludarabine (Fludara) in people with Hematologic Disease, run by He Huang at 1 site in China.
Trial summary
This study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo HSCT) but lack suitable donors. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hematologic Disease
- What is being tested?
- Busulfan (Busulfex), Cyclophosphamide (CTX) and Fludarabine (Fludara)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2022to 31 Oct 2027
- Phase
- Phase 1
- 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
- Adult patients (18-60 years old) with hematological malignancies and indications for hematopoietic stem cell transplantation;
- Non blood donors without human leukocyte antigen (HLA) high-resolution typing ≥ 9/10, or those who have difficulty finding non blood donors due to urgent medical conditions;
- No suitable HLA matching haploidentical donor available;
- There are suitable unrelated HLA mismatched (HLA high-resolution typing<9/10) donors;
- The subjects or their legal representatives shall sign an informed consent form before the start of the clinical study.
Who cannot join
- Patients with severe liver and kidney function (alanine aminotransferase>2.5 times the upper limit of normal, blood creatinine>1.5 times the upper limit of normal) and cardiopulmonary dysfunction (New York Heart Association (NYHA) III/IV heart function, ejection fraction<50%, severe obstructive or restrictive ventilation dysfunction);
- Merge active infections;
- Eastern Cooperative Oncology Group Performance Status (ECOG) score ≥ 2 points;
- Secondary tumors with merged activity;
- Severe central nervous system or mental illness leading to the inability to autonomously choose to enter or exit clinical trials;
- Combine other allo hematopoietic stem cell transplantation (HSCT) contraindications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, 310003
Yishan Ye, +86 57187236706, yeyishan@zju.edu.cn
He Huang
About this study
Official title: A Prospective Single-arm Trial on Human Leukocyte Antigen (HLA) Mismatched Unrelated Allogeneic Hematopoietic Stem Cell Transplantation
This study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo HSCT) but lack suitable donors. This project plans to use highly mismatched unrelated HLA mismatched donors. Ultimately, an unrelated human leukocyte antigen (HLA) mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of this group of patients and truly enter the era of "everyone has a donor" for allo HSCT.
Read the detailed description
This study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo HSCT) but lack suitable donors. This project plans to use highly mismatched unrelated HLA mismatched donors. Ultimately, an unrelated human leukocyte antigen (HLA) mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of this group of patients and truly enter the era of "everyone has a donor" for allo HSCT.
- Conditions
- Hematologic Disease
- Being tested
- Busulfan (Busulfex), Cyclophosphamide (CTX), Fludarabine (Fludara), Semustine (MeccNU)
- Keywords
- Hematopoietic cell transplantation, HLA mismatch, Hematologic diseases
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Busulfan (Busulfex)Drug
Myeloablative conditioning: Busulfan (Bu，3.2 mg/kg/d IV -8d ~-6d); Reduced intensity conditioning: Busulfan (Bu，3.2 mg/kg/d IV -7d~-5d);
Cyclophosphamide (CTX)Drug
Myeloablative conditioning: Cyclophosphamide (Cy，1.8g/m2, -5d, -4d) Cyclophosphamide is not used for reduced intensity conditioning
Fludarabine (Fludara)Drug
Myeloablative conditioning: Fludarabine (Flu，30 mg/m2/d IV -6d ~ -2d); Reduced intensity conditioning: Fludarabine (Flu，30mg/m2 /d IV -10d~-5d);
Semustine (MeccNU)Drug
For both myeloablative and reduced intensity conditioning:
Semustine (MeCCNU: 250 mg/m2 orally-3d)
| Study group | Role | What they receive |
|---|---|---|
| HLA mismatch | Experimental | Myeloablative conditioning regimen was used when patient is below 50 and with a HCT-CI score <2; Reduced intensity conditioning regimen was used when patient is over 50 or with HCT-CI score ≥2. Receives: Drug: Busulfan (Busulfex); Drug: Cyclophosphamide (CTX); Drug: Fludarabine (Fludara); Drug: Semustine (MeccNU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival (OS) after allogeneic hematopoietic cell transplantation is defined as the proportion of patients who are alive at a specified time point following the transplantation, regardless of disease status or cause of death.
Measured: 1-year
Secondary outcomes (6)
Neutrophil engraftment rate
The 28-day neutrophil engraftment rate is assessed, with neutrophil engraftment defined as achievement of an absolute neutrophil count (ANC) of ≥ 0.5 × 10⁹/L for three consecutive days.
Measured: 28-days
Platelet engraftment rate
The 28-day platelet engraftment rate is assessed, with platelet engraftment defined as achievement of a platelet count of ≥ 20 × 10⁹/L without transfusion support for at least seven consecutive days.
Measured: 28-days
GVHD
Cumulative incidence of aGvHD and cGvHD in different target organs and overall population.
Measured: 180 days and 2 year
Relapse
Cumulative incidence of disease relapse after transplantation.
Measured: 1-year
Progression-free survival
Progression-free survival (PFS) after allogeneic hematopoietic cell transplantation is defined as the length of time a patient survives without evidence of disease progression or relapse following the transplantation.
Measured: 1-year
Graft-versus-host disease (GVHD)-free, relapse-free survival (GRFS)
Graft-versus-host disease (GVHD)-free, relapse-free survival (GRFS) after allogeneic hematopoietic cell transplantation is defined as the time a patient survives without experiencing grade III-IV acute GVHD, severe chronic GVHD, relapse, or death.
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start4 Aug 2022
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DiseaseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- He Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, He Huang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809712
- Sponsor's protocol ID
- MMU-001
- Acronym
- MIGHT
- Status last verified
- Jun 2026
- First submitted
- 4 Oct 2024
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-arm Trial on Human Leukocyte Antigen (HLA) Mismatched Unrelated Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06809712
- Acronym / sponsor ID
- MIGHT / MMU-001
- Conditions
- Hematologic Disease
- Keywords
- Hematopoietic cell transplantation, HLA mismatch, Hematologic diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- He HuangUniversity, hospital or other
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 5 Feb 2025 (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 study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo HSCT) but lack suitable donors. This project plans to use highly mismatched unrelated HLA mismatched donors. Ultimately, an unrelated human leukocyte antigen (HLA) mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of this group of patients and truly enter the era of "everyone has a donor" for allo HSCT.
Detailed description
This study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo HSCT) but lack suitable donors. This project plans to use highly mismatched unrelated HLA mismatched donors. Ultimately, an unrelated human leukocyte antigen (HLA) mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of this group of patients and truly enter the era of "everyone has a donor" for allo HSCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HLA mismatch | Experimental | Drug: Busulfan (Busulfex), Drug: Cyclophosphamide (CTX), Drug: Fludarabine (Fludara), Drug: Semustine (MeccNU)Myeloablative conditioning regimen was used when patient is below 50 and with a HCT-CI score <2; Reduced intensity conditioning regimen was used when patient is over 50 or with HCT-CI score ≥2. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult patients (18-60 years old) with hematological malignancies and indications for hematopoietic stem cell transplantation;
- Non blood donors without human leukocyte antigen (HLA) high-resolution typing ≥ 9/10, or those who have difficulty finding non blood donors due to urgent medical conditions;
- No suitable HLA matching haploidentical donor available;
- There are suitable unrelated HLA mismatched (HLA high-resolution typing<9/10) donors;
- The subjects or their legal representatives shall sign an informed consent form before the start of the clinical study.
Key exclusion criteria (6 listed)
- Patients with severe liver and kidney function (alanine aminotransferase>2.5 times the upper limit of normal, blood creatinine>1.5 times the upper limit of normal) and cardiopulmonary dysfunction (New York Heart Association (NYHA) III/IV heart function, ejection fraction<50%, severe obstructive or restrictive ventilation dysfunction);
- Merge active infections;
- Eastern Cooperative Oncology Group Performance Status (ECOG) score ≥ 2 points;
- Secondary tumors with merged activity;
- Severe central nervous system or mental illness leading to the inability to autonomously choose to enter or exit clinical trials;
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 |
|---|---|---|
| Busulfan (Busulfex)Myeloablative conditioning: Busulfan (Bu，3.2 mg/kg/d IV -8d ~-6d); Reduced intensity conditioning: Busulfan (Bu，3.2 mg/kg/d IV -7d~-5d); | Drug | HLA mismatch |
| Cyclophosphamide (CTX)Myeloablative conditioning: Cyclophosphamide (Cy，1.8g/m2, -5d, -4d) Cyclophosphamide is not used for reduced intensity conditioning | Drug | HLA mismatch |
| Fludarabine (Fludara)Myeloablative conditioning: Fludarabine (Flu，30 mg/m2/d IV -6d ~ -2d); Reduced intensity conditioning: Fludarabine (Flu，30mg/m2 /d IV -10d~-5d); | Drug | HLA mismatch |
| Semustine (MeccNU)For both myeloablative and reduced intensity conditioning: Semustine (MeCCNU: 250 mg/m2 orally-3d) | Drug | HLA mismatch |
Primary outcome
Overall survival
Time frame: 1-year
Overall survival (OS) after allogeneic hematopoietic cell transplantation is defined as the proportion of patients who are alive at a specified time point following the transplantation, regardless of disease status or cause of death.
6 secondary outcomes
Neutrophil engraftment rate
Time frame: 28-days
Platelet engraftment rate
Time frame: 28-days
GVHD
Time frame: 180 days and 2 year
Relapse
Time frame: 1-year
Progression-free survival
Time frame: 1-year
Graft-versus-host disease (GVHD)-free, relapse-free survival (GRFS)
Time frame: 1-year
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 9 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Busulfan (Busulfex), Cyclophosphamide (CTX) and Fludarabine (Fludara) in people with Hematologic Disease, run by He Huang at 1 site in 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yishan Ye, MD., PhD (+8618268068056, yeyishan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 1-year). 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 9 Jun 2026.