Age-Stratified Conditioning Regimen Efficacy for MDS Haplo-HSCT

Peking University

Status and phase: Enrolling; Phase 2

Conditions: Myelodysplastic Syndromes

Treatments: Drug: RTC conditioning regimen and Modified Bu/Cy conditioning regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT07677306

RTC Haplo-MDS

Details and patient eligibility

About

This study plan aims to enroll adult patients diagnosed with myelodysplastic syndrome (MDS) who are scheduled to receive T-cell-replete haploidentical hematopoietic stem cell transplantation. After obtaining written informed consent, participants will receive either reduced-toxicity Bu/Flu/Cy/ATG conditioning regimen (for patients aged ≥55 years) or standard myeloablative modified Bu/Cy+ATG conditioning regimen (for patients aged <55 years) followed by unified post-transplant immunosuppression and supportive care. The objective is to prospectively characterize the 1-year transplant-related mortality and comprehensively evaluate hematopoietic engraftment, graft-versus-host disease, infection, relapse, survival outcomes and conditioning-related organ toxicity among all enrolled patients undergoing haploidentical transplantation.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who had low- and intermediate-risk MDS without ISD nor URD receiving haploidentical hematopoietic stem cell transplantation

Exclusion criteria

• Patients having ISD or URD; patients having high-risk MDS; patients with active infection; patients with poor compliance; patients with organ failure

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Age-Stratified Conditioning Regimen

Other group

Description:

MDS patients without identical sibling donor or unrelated donor would receive haplo-HSCT. Participants will receive either reduced-toxicity Bu/Flu/Cy/ATG conditioning regimen (for patients aged ≥55 years) or standard myeloablative modified Bu/Cy+ATG conditioning regimen (for patients aged \<55 years) followed by unified post-transplant immunosuppression and supportive care.

Treatment:

Drug: RTC conditioning regimen and Modified Bu/Cy conditioning regimen