RecruitingPhase 2NCT06783790

Avapritinib Combined With Azacitidine and Venetoclax in the Treatment of Relapsed AML After Allo-HSCT

An Exploratory Clinical Study of the Safety and Efficacy of Avapritinib Combined With Azacitidine and Venetoclax in the Treatment of Relapsed Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

20 participants

Start Date

Jan 20, 2025

Study Type

INTERVENTIONAL

Conditions

AML (Acute Myelogenous Leukemia)

Summary

This is a single-center, prospective, single-arm, exploratory clinical study. To explore the efficacy and safety of avapritinib in patients with recurrent acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation with C-KIT mutation RUNX1::RUNX1T1 or CBFB::MYH11.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three cancer drugs — avapritinib, azacitidine, and venetoclax — for people with acute myeloid leukemia (AML, a blood cancer) that has come back after a bone marrow transplant. Researchers are looking for a treatment that can help when the cancer returns. **You may be eligible if...** - Your AML has relapsed (come back) after a bone marrow transplant - Your cancer has a specific gene mutation called C-KIT D816, C-KIT N822, or certain gene fusions (CBFB::MYH11 or RUNX1::RUNX1T1) - You are physically well enough to tolerate treatment (good performance status) - You are 18 years or older **You may NOT be eligible if...** - You do not have the required genetic mutations - You have severe organ dysfunction that prevents you from receiving treatment - You are not a candidate for further cancer therapy 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAvapritinib, azacitidine, Venetoclax

A: Induction therapy period: After patients were screened and enrolled, they began to receive 1-2 cycles of induction therapy, and the specific administration regimen was as follows: Avapritinib 100mg po qd D1-D14, azacitidine 35mg/m2 ih D1-D5, Venetoclax 100mg po qd D1-D14. The 28-day cycle was followed by curative effect evaluation at the end of each cycle. Patients who achieved complete remission entered the consolidation treatment stage. B: Consolidation therapy period: Patients who achieved complete remission after 1-2 cycles of induction therapy continued to receive avapritinib 100mg/d po. monotherapy for consolidation therapy, with a cycle of 28 days and a total of 4 cycles

Locations(1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06783790

Related Trials

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

NCT0685942413 locations

A Phase 1 Study of CG009301 for Injection in Adult Subjects With Recurrent or Refractory Haematological Malignancies

NCT073471713 locations

The Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia

NCT072321341 location

The Efficacy and Safety Assessment of Allogeneic γδ T Cells in Patients With MRD-positive AML After Allo-HSCT

NCT071267821 location

The Application of CAR-T Cell Therapy in Relapsed and Refractory Malignant Hematologic Tumors

NCT069117101 location