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Modified Second Haplo-transplantation for Graft Failure | Clinical Trials | Clareo Health

RECRUITINGNA

Modified Second Haplo-transplantation for Graft Failure

Second Haploidentical Transplantation with Modified Regimen for Graft Failure After the First Allogeneic Stem Cell Transplantation

NCT06512545•Peking University People's Hospital

View on ClinicalTrials.gov

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

Age

14 - No limit years

Sex

ALL

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,

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

July 1, 2024

Primary Completion Date

June 30, 2026

Completion Date

June 30, 2026

Last Updated

November 29, 2024

Enrollment

ESTIMATED participants

Conditions

Graft FailureStem Cell Transplant Complications

Interventions

second allogeneic stem cell transplantation

OTHER

Contacts

Yu-qian Sun, M.D.

CONTACT

+86-10-88324577 sunyuqian83@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 29, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Modified Second Haplo-transplantation for Graft Failure

Inclusion Criteria

Exclusion Criteria

REVEAL Biomarkers of Engraftment After Alternative Donor HSCT

A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy

Prevention of Graft Rejection in Hematopoietic Stem Cell Transplant (HSCT) Recipients

Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haplo-HSCT

Beijing Protocol in Patients Receiving More Than 5/10 HLA-mismatched Allo-HSCT

Delirium in Children Undergoing Stem Cell Transplantation