Modified Second Haplo-transplantation for Graft Failure
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: second allogeneic stem cell transplantation.
- Who it may be relevant to
- Registry conditions: Graft Failure, Stem Cell Transplant Complications. Basic parameters: from 14 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 →
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Official title
Second Haploidentical Transplantation with Modified Regimen for Graft Failure After the First Allogeneic Stem Cell Transplantation
Overview
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.
Interventions
- Other 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)
Primary outcome measures
- Engraftment of neutrophils [Time frame: 28 days after second transplantation]
Secondary outcome measures (7)
- Engraftment of Platelet [Time frame: 100 days after second transplantation]
- TRM at 28 day [Time frame: 28 days after second transplantation]
- TRM at 100 day [Time frame: 100 days after second transplantation]
- GVHD [Time frame: Participants will be followed for an expected average of 1 year]
- OS [Time frame: Participants will be followed for an expected average of 1 year]
- LFS [Time frame: Participants will be followed for an expected average of 1 year]
- CIR [Time frame: Participants will be followed for an expected average of 1 year]
Eligibility criteria
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,
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
- Treatment
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT06512545 · 2024PHB181-001