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NCT Number: NCT06512545

Modified Second Haplo-transplantation for Graft Failure

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.

Recruiting

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Key information

Conditions

Graft Failure Stem Cell Transplant Complications

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

Yu-qian Sun, M.D.

CONTACT

[email protected]

+86-10-88324577

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

second allogeneic stem cell transplantation

Other
  • Change another donor if possible
  • 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)
  • 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 outcomes

  1. Engraftment of neutrophils

    Time frame: 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.

Secondary outcomes

  1. Engraftment of Platelet

    Time frame: 100 days after second transplantation

    Platelet engraftment was defined as the first of 7 consecutive days that platelet counts ≥20 × 10^9/L in the absence of platelet transfusion

  2. TRM at 28 day

    Time frame: 28 days after second transplantation

    treatment-related mortality(TRM) was defined as death from any cause other than relapse.

  3. TRM at 100 day

    Time frame: 100 days after second transplantation

    treatment-related mortality (TRM) was defined as death from any cause other than relapse

  4. GVHD

    Time frame: Participants will be followed for an expected average of 1 year

    Both acute and chronic GVHD was diagnosed and graded according to international criteria.

  5. OS

    Time frame: Participants will be followed for an expected average of 1 year

    Overall survival (OS)

  6. LFS

    Time frame: Participants will be followed for an expected average of 1 year

    Leukemia-free survival (LFS) was defined as the survival period with continuous CR.

  7. CIR

    Time frame: Participants will be followed for an expected average of 1 year

    The cumulative incidence of relapse (CIR)

Study contacts

Contact information is provided by the study sponsor or research team.

Yu-qian Sun, M.D.

CONTACT

[email protected]

+86-10-88324577

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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