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

NCT06783790 | Recruiting Phase 2

• 1 other identifier: IIT2024097
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

AML (Acute Myelogenous Leukemia)

Outcome Measures

Primary Outcomes (1)

• 2-month ORR after induction therapy

  2-month objective remission rate after induction therapy

  2 months after induction therapy

Secondary Outcomes (4)

• CR rate after induction therapy

  2 months after induction therapy

• MRD negative rate after induction therapy

  2 months after induction therapy

• Response rate after Consolidation treatment

  6 months after Consolidation treatment

• Safety

  2 years

Study Arms (1)

Arm 1

EXPERIMENTAL

Avapritinib combined with Azacitidine and Venetoclax

Drug: Avapritinib, azacitidine, Venetoclax

Interventions

Avapritinib, azacitidine, Venetoclax DRUG

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

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects met the criteria for recurrence after allogeneic transplantation: re-emergence of leukemia cells or bone marrow original cells in peripheral blood \>5% (except for other causes such as bone marrow recovery period) or extramedullary leukemia cell infiltration or molecular or cytogenetic recurrence.
• Bone marrow molecular biology detected C-KIT D816 or C-KIT N822 mutations
• Patients with CBFB::MYH11 gene or RUNX1::RUNX1T1 fusion gene detected.
• Eastern Cancer Collaboration Group (ECOG) physical status score 0-2 points.
• Liver, kidney and cardiopulmonary functions met the following requirements: Within 2 weeks before enrollment ① creatinine ≤1.5 upper limit of normal value; ② Left ventricular ejection fraction ≥50%; ③ Blood oxygen saturation \>91%; ④ Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; Myocardial enzymes \< 2 times the upper limit of normal (for the same age)
• Volunteer to participate in clinical studies and sign informed consent, willing to follow and able to complete all trial procedures.

You may not qualify if:

• Known allergy to KIT inhibitor drug analogues.
• Patients who have received previous treatment with Midostaurin.
• Patients who have previously been treated with mutation-specific C-KIT inhibitors and have developed disease progression during treatment.
• FLT3-ITD mutation in patients with recurrent/refractory disease (except low gene ratio).
• HIV infected persons, HBV, HCV active infected persons.
• Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases.
• With uncontrolled active GVHD (NIH for GVHD diagnosis and classification standards, aGVHD classification refer to the improved Glucksberg standard).
• Central nervous system leukemia.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

avapritinib; Azacitidine; venetoclax

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Erlie Jiang

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erlie Jiang

CONTACT

15122538107; jiangerlie@ihcams.ac.cn

Yigeng Cao

CONTACT

18622477067; caoyigeng@ams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: January 20, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 20, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)