Using ATG and low-dose cyclophosphamide to prevent GVHD in transplant patients

Randomized Trial of Anti-thymocyte Globulin Plus Low-dose Post-transplant Cyclophosphamide for GVHD Prevention in Haploidentical Donor HCT

This study is testing if a combination of two medications can help prevent graft versus host disease in patients with acute leukemia or myelodysplastic syndrome who are getting their first stem cell transplant from a partially matched donor.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 196 (estimated)
• Ages: 12 Years to 55 Years
• Sex: All
• Sponsor: Peking University People's Hospital (Academic / other)
• Drugs / interventions: cyclophosphamide
• Locations: 1 site (Beijing)
• Trial ID: NCT06108739 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the combined use of anti-thymocyte globulin (ATG) and low-dose post-transplant cyclophosphamide (PTCy) to reduce the incidence of graft versus host disease (GVHD) in patients undergoing haploidentical hematopoietic stem cell transplantation. The study aims to improve long-term outcomes and decrease non-relapse mortality associated with severe GVHD. Eligible participants include patients with acute leukemia or myelodysplastic syndrome who are receiving their first transplant from a haploidentical donor. The trial will assess the effectiveness of this regimen in maintaining engraftment and minimizing disease relapse.

Who should consider this trial

Good fit: Ideal candidates are patients aged 12-55 with acute leukemia or myelodysplastic syndrome undergoing their first haploidentical stem cell transplantation.

Not a fit: Patients with severe organ dysfunction, refractory malignancies, or other active malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly lower the risk of GVHD and improve survival rates for patients undergoing haploidentical transplants.

How similar studies have performed: Previous studies have shown promising results with similar approaches using ATG and PTCy, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Patients with acute leukemia and/or myelodysplastic syndrome undergoing their first allogeneic hematopoietic stem cell transplantation;
2. Male or female , aged 12-55 years;
3. Haploidentical donor transplantation;
4. ECOG score ≤3; The basic organ function tests met the following standards;

1) Cardiac ejection index \>55% 2) Creatinine ≤1.5 times the highest normal value (ULN)

Exclusion Criteria:

1. Severe brain, heart, kidney or liver dysfunction;
2. Refractory malignant state;
3. Patients with other malignant tumors requiring treatment;
4. Clinically uncontrolled severe active infection;
5. The expected survival time was less than 3 months.
6. A history of severe anaphylaxis.
7. Pregnant or lactating women;
8. Any condition considered by the investigators to be unsuitable for enrollment.

Where this trial is running

Beijing

• Peking University People's Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Yu Wang, M.D.

Conditions Hematologic Malignancy