Modified Second Haplo-transplantation for Graft Failure

NCT06512545 · tracked via the Priya Life Science China tracker

Sponsor

Peking University People's Hospital

Phase

Not applicable

Started

2024-07-01

Last updated

2024-11-29

Condition(s) studied

Graft FailureStem Cell Transplant Complications

Investigational drug(s) / intervention(s)

second allogeneic stem cell transplantation

second allogeneic stem cell transplantation: 1. Change another donor if possible 2. Conditioning regimen: fludarabine (30mg/m2/day, days -6 to -2 )/cyclophosphamide (1g/m2/day, days -5 to -4)/rabbit antithymocyte globulin (1.5mg/kg/day, days -4 to -2) 3. GVHD prophylaxis: cyclosporine A (concentration 150-250ng/ml), mycophenolate mofetil (0.5g bid -3d to neutrophil engraftment)+anti CD25 monoAb (20mg, +1d, +8d, +15d)

Study summary

Graft failure is a fatal complication following allogeneic stem cell transplantation where a second transplantation is usually required for salvage. We previously reported encouraging results with a novel Flu/Cy regimen. However, there are still around 20% patients developed delayed platelet recovery. We designed a modified regimen to further improve the hematopoietic reconstitution after second transplantation. This prospective, single-arm study aims to investigate the safety and efficacy of this modified regimen.

Eligibility

Sex

ALL

Min age

14 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 1.Primary disease: hematological malignancies(AML, CML, MDS, lymphoma, etc.); 2.Graft failure after first allogeneic stem cell transplantation; 3.Time from the first transplantation to the second transplantation is less than 180 days; 4. Age≥14 years. Exclusion Criteria: * 1\. Active infections; 2. Active GVHD; 3. Organ dysfunction: hepatic injury (Tbil≥2ULN), renal injury (Cr≥1.5ULN), heart injury (EF%\<50% or symptomatic heart failure); 4. Eastern Cooperative Oncology Group (ECOG) score\>2; 5. Expected life time\<30 days; 5. Patients could not cooperate; 6. Other situations that are considered inappropriate for enrollment by the investigators,

Primary outcome measure(s)

Engraftment of neutrophils — 28 days after second transplantation
Engraftment of neutrophils was defined as the first of 3 consecutive days when the absolute neutrophil count achieved 500/uL.

Trial sites (1)

Facility	City	Region	Status
Peking University People's Hospital	Beijing	Beijing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06512545 on ClinicalTrials.gov ↗ ← All trials in China