Avapritinib Maintenance for AML With KIT Mutations

NCT06765915 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: RJ-BMT-011
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, single-arm clinical study of evaluate the efficacy and safety of avapritinib as maintenance therapy following allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia patients with KIT mutation.

Conditions

AML, Adult

Keywords

AML; KIT mutation; avapritinib

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of relapse

  disease relapse

  through study completion, an average of 2 year

Secondary Outcomes (2)

• Overall survival

  through study completion, an average of 2 year

• Non relapse mortality

  through study completion, an average of 2 year

Study Arms (1)

Experimental arm

EXPERIMENTAL

Allo-HSCT recipients will begin maintenance therapy with oral Avapritinib tablets at a dose of 100 mg/day, starting 2-4 months post-transplantation. Each treatment cycle lasts 28 days, and therapy will continue for up to 2 years or until disease progression or unacceptable toxicity occurs.

Drug: Avapritinib

Interventions

Avapritinib DRUG

After allo-HSCT, CBF-AML patients who have kit mutation would receive avapritinib for maintenance therapy.

Also known as: KIT inhibitor

Experimental arm

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥ 14 years old;
• First allo-HSCT for AML (including secondary AML) ;
• KIT mutation at diagnosis (no restriction on locus for kit mutation
• CR and negative MFC-MRD prior to initiation of maintenance therapy;
• Absolute neutrophil count ≥ 1.0 x 109 /L, platelets ≥ 75 x 109 /L, hemoglobin ≥ 80 g/L before maintenance;
• Normal functioning of major organs and laboratory findings in accordance with the following criteria:AST and ALT) ≤ 3x ULN; Total serum bilirubin ≤ 1.5x ULN unless the patient has Gilbert syndrome; patients with Gilbert-Meulengracht syndrome with bilirubin ≤ 3.0 times the upper limit of normal and direct bilirubin ≤ 1.5 times the upper limit of normal may be included; HB ≥ 70 g/L (had not received a red blood cell transfusion within 1 week prior to administration); ANC ≥ 0.8 x 10\^9/L (had not received long-acting colony-stimulating factor (LACSF) within 1 week prior to administration and short-acting colony-stimulating factor (SACSF) within 3 days prior to administration); Platelet count ≥ 20 x 10\^9/L (had not received a platelet transfusion within 1 week prior to administration); serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 60 mL/min; Coagulation function: International Normalized Ratio (INR) ≤1.5×ULN, Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN; Left ventricular ejection fraction (LVEF) ≥45%;
• ECOG PS 0-2 points;
• Expected survival ≥ 3 months;
• Patient consent

You may not qualify if:

• concurrently receiving other targeted therapies for AML;
• Prior treatment with a TKI inhibitor that proved ineffective;
• with concurrent FLT3-ITD mutations at enrollment;
• Acute/chronic graft-versus-host disease requiring systemic immunosuppressive therapy prior to maintenance therapy;
• Accompanied by other malignant tumors requiring treatment;
• Have important organ-based diseases: e.g., myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal failure;
• Active, uncontrolled infection;
• HIV-positive, active hepatitis B (HBV) or active hepatitis C (HCV) requiring antiviral therapy;
• Other interventional clinical studies have been enrolled;
• Men and women of childbearing potential are unwilling to use contraception during and for 12 months after treatment;
• The investigator believes that there are other conditions that make the patient unsuitable for participation in this study.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital of Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

avapritinib

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xiaoxia HU, Doctor

CONTACT

02164370045; hxx12276@rjh.com.cn

Xiaoxia HU

CONTACT

02164370045; hu_xiaoxia@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: January 9, 2025
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2028
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

CN (1)