RecruitingPhase 2NCT06130579

Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT

Interferon-α for Preventing Relapse in TP53+ Myeloid Malignancy Post Allo-HSCT


Sponsor

Peking University People's Hospital

Enrollment

35 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To investigate the efficacy of interferon-α prophylaxis in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) with TP53 mutation who were negative for minimal residual disease (MRD) by flow cytometry within 2 months after allogeneic hematopoietic stem cell transplantation. To explore the efficacy of interferon-α in reducing the relapse rate of AML/MDS patients with TP53 mutation after allogeneic hematopoietic stem cell transplantation (allo-HSCT).


Eligibility

Min Age: 12 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial studies whether interferon-alpha, a type of immune-stimulating drug, can help prevent relapse in people with blood cancers (myelodysplastic syndrome or acute myeloid leukemia) that have a TP53 gene mutation after they have received a bone marrow transplant from a donor. TP53 mutations are associated with higher relapse risk, and this study aims to use interferon to keep the cancer from coming back. **You may be eligible if...** - You are 12 to 65 years old - You have been diagnosed with MDS or AML with a TP53 mutation - You have recently received your first allogeneic (donor) stem cell/bone marrow transplant - Your MRD (minimal residual disease) testing was negative within 2 months after transplant - Your general health (Karnofsky score) and organ function are adequate - You have no history of severe graft-versus-host disease (GVHD) **You may NOT be eligible if...** - You have severe heart, kidney, or liver disease - You have another active cancer requiring treatment - You have a serious mental illness that prevents you from following the study protocol - You have a life-threatening infection - You are enrolled in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIFN-Α

Leukemia-associated immunophenotyping (LAIPs) was performed by flow cytometry at +1 month and +2 month after HSCT. If MRD was negative on two consecutive flow cytometry assays, interferon-α prophylaxis was initiated on day +75 after transplantation, and cyclosporine was tapered on day +100 after transplantation. The dose of interferon-α was 3 million units/time, subcutaneously injected twice a week. Cycles were given every 4 weeks until hematologic relapse or up to 6 cycles.


Locations(1)

Deparment of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT06130579


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