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NCT Number: NCT06984536

Reduced ATG Plus Mini PTCy for GVHD Prophylaxis in Haplo-SCT

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is regarded as a curative therapy for a variety of hematological malignancies and nonmalignant diseases. However, donor limitations have restricted the widespread use of allo-HSCT for a long period. The development and success of haploidentical allografts worldwide makes "everyone has a donor" a reality. In the past two decades, researchers have established several haploidentical HSCT (haplo-HSCT) protocols based on different approaches to induce immune tolerance. The representative approaches for haplo-HSCT without in vitro. T cell depletion include granulocyte colony-stimulating factor (G-CSF) plus Anti-human Thymocyte Immunoglobulin (ATG) based (Beijing Protocol) and post-transplantation cyclophosphamide based (PT-Cy, Baltimore Protocol) protocols. Both of two protocols have common problems that need to be solved, including infection transplantation related mortality and disease relapse. The main aim of this study is to explore whether the combined protocol can improve the efficacy of haploidentical transplantation further.

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Key information

Conditions

Myelodysplastic Syndrome Acute Leukemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with AL - CR and/or myelodysplastic syndromes undergoing allogeneic hematopoietic stem cell transplantation for the first time;
  • No gender limit, aged 12 - 65 years;
  • Planned haploidentical donor transplantation, excluding transplantation from maternal and collateral donors;
  • Eastern Cooperative Oncology Group (ECOG) performance status score≤3 points;
  • Baseline organ function tests meet the following criteria:

(1) Left ventricular ejection fraction (LVEF) > 55%; (2) Serum creatinine ≤ 1.5 × upper limit of normal (ULN).

Exclusion criteria

  • Patients with severe dysfunction of brain, heart, kidney or liver;
  • Those in refractory malignant status;
  • Patients with other malignancies requiring treatment;
  • Presence of uncontrolled severe active infection clinically;
  • Expected survival period of less than 3 months;
  • History of severe allergic reactions;
  • Pregnant or breastfeeding women; (8)Presence of any condition deemed by the investigator as unsuitable for study enrollment.

Treatment and study plan

Reduced ATG plus mini PTCy

Drug

The conditioning protocol comprises cytarabine (Ara-C) (4 g/m2/day, days -9), busulfan (Bu) (3.2 mg/kg/day, days -8 to -6), cyclophosphamide (Cy) (1.8 g/m2/kg, days -5 and -4), simustine (250 mg/m2, day -3) and r-ATG (total 7.5mg/kg ,from days -5 to -2). Mini PTCy 14.5mg/kg/day will be given on day +3 and +4.

Primary outcomes

  1. Non-relapse mortality

    Time frame: 100 days

    None-relapse mortality within 100 days post transplantation

Secondary outcomes

  1. Regimen related toxicity

    Time frame: 30 days post transplantation

    Regimen related toxicity will be evaluated by Bearman Criteria from the begining of conditioning to 1 month post HSCT. The organ functions that need to be assessed include the heart, liver, kidneys, cystitis, oral mucositis, and the gastrointestinal tract.

  2. Engraftment

    Time frame: Within 30 days post transplant. Myeloid engraftment was defined as the first of three consecutive days with an ANC 0.5×109 /L, and platelet engraftment was defined as the day the platelet count met or exceeded 20×10^9 /L without transfusion for a week.

    Myeloid and platelet engraftment

  3. Disease relapse

    Time frame: 1 year post transplantation

    The incidence of disease relapse

  4. Disease free survival

    Time frame: 1 year post transplantation

    The time from the start of transplantation until a patient experiences leukemia relapse or death from any cause, whichever occurs first.

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Wang, M.D.

CONTACT

[email protected]

86-010-8832-6000

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

Reduced-dose Anti-thymocyte Globulin Plus Mini-dose Post-transplant Cyclophosphamide for GVHD Prevention in Haploidentical Donor HCT for Hematologic Malignancy

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 22, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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