RecruitingPhase 2NCT07078591

Venetoclax-containing Therapy Combined With Microtransplant for Newly Diagnosed AML

Phase 2 Study of Venetoclax-containing Therapy in Combination With HLA-mismatched Mobilized Peripheral Blood Mononuclear Cell Infusion for Newly Diagnosed Acute Myeloid Leukemia


Sponsor

Beijing 302 Hospital

Enrollment

50 participants

Start Date

Jun 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate whether HLA-mismatched donor G-CSF mobilized peripheral blood mononuclear cell (GPBMC) infusion with venetoclax-containing regimens (microtransplant, MST) could improve survival in adult patients with newly diagnosed acute myeloid leukemia (AML).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment for people newly diagnosed with a type of blood cancer called acute myeloid leukemia (AML). The treatment combines a drug called venetoclax with a technique called microtransplant, where donor stem cells are used to help the immune system fight the cancer — without a full stem cell transplant. **You may be eligible if...** - You are 18 or older and have been newly diagnosed with AML - You have not received prior treatment for leukemia (except hydroxyurea or a blood-filtering procedure) - Your heart, liver, and kidneys are functioning well enough for treatment - You have a willing donor (at least 18 years old) who partially matches your immune system **You may NOT be eligible if...** - You have a specific subtype of leukemia called acute promyelocytic leukemia, or certain other related conditions - You have an uncontrolled infection or active bleeding - You have serious heart disease, an uncontrolled autoimmune condition, or a severe psychiatric disorder - You are pregnant, breastfeeding, or not willing to use contraception - You have had major surgery in the past 4 weeks 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

DRUGVenetoclax

Given PO

DRUGAzacitidine (AZA)

Given SC

DRUGDaunorubicin

Given IV

DRUGIdarubicin(IDA)

Given IV

DRUGCytarabine (Ara-C)

Given IV

BIOLOGICALGPBMC infusion

HLA-mismatched donor GPBMC infusion


Locations(1)

Department of Hematology, the Fifth Medical Center of Chinese PLA General Hospital

Beijing, China

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NCT07078591


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