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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Avapritinib, azacitidine, Venetoclax

Treatment groups

20 Participants
are divided into 1 treatment group