Human Leukocyte Antigen (HLA) Mismatched Related Allogeneic Hematopoietic Stem Cell Transplantation
NCT ID: NCT06809699
Last Updated: 2025-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
29 participants
INTERVENTIONAL
2022-08-04
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HLA-mismatch related
The myeloablative conditioning is used when the patient is below 50 and with an HCT-CI\<2. The reduced intensity conditioning is used when the patient is over 50 or with an HCT-CI≥2.
Busulfan (Busulfex)
For myeloablative conditioning: Busulfan (Bu，3.2 mg/kg/d IV -8d \~-6d) For reduced intensity conditioning: (Bu，3.2 mg/kg/d IV -7d\~-5d)
Cyclophosphamide (CTX)
Cyclophosphamide is only used in myeloablative conditioning (Cy，1.8g/m2, -5d, -4d)
Fludarabine (Fludara)
For myeloablative conditioning: Fludarabine (Flu，30 mg/m2/d IV -6d \~ -2d) For reduced intensity conditioning: Fludarabine（Flu，30mg/m2 /d IV -10d\~-5d）
Semustine (MeCCNU)
For both myeloablative and reduced intensity conditioning: Semustine (MECCNU，250 mg/m2 orally-3d).
Interventions
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Busulfan (Busulfex)
For myeloablative conditioning: Busulfan (Bu，3.2 mg/kg/d IV -8d \~-6d) For reduced intensity conditioning: (Bu，3.2 mg/kg/d IV -7d\~-5d)
Cyclophosphamide (CTX)
Cyclophosphamide is only used in myeloablative conditioning (Cy，1.8g/m2, -5d, -4d)
Fludarabine (Fludara)
For myeloablative conditioning: Fludarabine (Flu，30 mg/m2/d IV -6d \~ -2d) For reduced intensity conditioning: Fludarabine（Flu，30mg/m2 /d IV -10d\~-5d）
Semustine (MeCCNU)
For both myeloablative and reduced intensity conditioning: Semustine (MECCNU，250 mg/m2 orally-3d).
Eligibility Criteria
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Inclusion Criteria
* No available donor with HLA high-resolution typing ≥ 9/10 or those who have difficulty finding donors due to urgent medical conditions;
* No suitable HLA matching haploidentical donor available;
* There is a suitable donor with mismatched HLA typing;
* The subjects or their legal representatives shall sign an informed consent form before the start of the clinical study.
Exclusion Criteria
* Merge active infections;
* Eastern Cooperative Oncology Group (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 HSCT contraindications.
18 Years
60 Years
ALL
No
Sponsors
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He Huang
OTHER
Responsible Party
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He Huang
Professor, Director of the Bone Marrow Transplantation Center, The First Affiliated Hospital, Zhejiang University School of Medicine
Locations
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The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MMR-001
Identifier Type: -
Identifier Source: org_study_id
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