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Modified Second Haplo-transplantation for Graft Failure

NCT ID: NCT06512545

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Graft Failure Stem Cell Transplant Complications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intervention arm

second haploidentical stem cell transplantation

Group Type EXPERIMENTAL

second allogeneic stem cell transplantation

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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,
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiao-Jun Huang

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiao-Jun Huang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology, Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yu-qian Sun, M.D.

Role: CONTACT

[email protected]
+86-10-88324577

Facility Contacts

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Yu-qian Sun, M.D.

Role: primary

[email protected]
+86-10-88324577

Other Identifiers

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2024PHB181-001

Identifier Type: -

Identifier Source: org_study_id