Menu
Recruiting NCT06984536

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

Phase II Interventional Myelodysplastic Syndrome Acute Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Reduced ATG plus mini PTCy.
Who it may be relevant to
Registry conditions: Myelodysplastic Syndrome, Acute Leukemia. Basic parameters: 12 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Reduced ATG plus mini PTCy
    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 outcome measures

  • Non-relapse mortality [Time frame: 100 days]
Secondary outcome measures (4)
  • Regimen related toxicity [Time frame: 30 days post transplantation]
  • 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.]
  • Disease relapse [Time frame: 1 year post transplantation]
  • Disease free survival [Time frame: 1 year post transplantation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • Peking University People'S Hospital — Beijing

Identifiers

NCT: NCT06984536 · Lower ATG plus miniPTCy

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗