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NCT05586074 | RECRUITING | Leukemia, Acute Myeloid (AML)

HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML
Sponsor:

Sunshine Lake Pharma Co., Ltd.

Brief Summary:

A randomized，multicenter, open-label Phase III, clinical study is conducted to evaluate the clinical benefit Clifutinib in Chinese patients with relapsed/ refractory (R/R) FLT3-mutated AML as shown with overall survival compared to salvage chemotherapy, and also to investigate the efficacy of Clifutinib as assessed by CR/CRh rate in these subjects.

Condition or disease

Leukemia, Acute Myeloid (AML)

Intervention/treatment

Clifutinib

LoDAC

Azacitidine

Decitabine

Ara-C±IDA

FLAG-IDA

Phase

PHASE3

Detailed Description:

Subjects who are at least 18 years and above at the time of signing informed consent may participate in this study. Subjects will be randomized in a 2:1 ratio to receive Clifutinib or salvage chemotherapy. Subjects will enter the screening period up to 28 days prior to the start of treatment. Prior to randomization, a salvage chemotherapy regimen will be pre-selected for each subjects; options will include low-dose cytarabine (LoDAC), azacitidine, decitabine, Ara-C±IDA or FLAG±IDA. The randomization will be stratified by response to first-line therapy and pre-selected salvage chemotherapy. Participants will be administered treatment over continuous 28-day cycles. After treatment discontinuation, participants will have a end-of-treatment visit within 7 days after treatment discontinuation, followed by a 30-day follow-up for safety. After that, long term follow-up will be done every 90 days.

Study Type : INTERVENTIONAL
Estimated Enrollment : 324 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : HEC73543 Versus Salvage Chemotherapy in Relapsed or Refractory FLT3-ITD Acute Myeloid Leukemia: a Multicenter, Open-label, Randomized Phase 3 Trial
Actual Study Start Date : 2023-03-03
Estimated Primary Completion Date : 2026-03-10
Estimated Study Completion Date : 2027-06-14

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Subject is ≥ 18 years of age at the time of obtaining informed consent.
  • * Subject has a diagnosis of primary acute myeloid leukemia (AML) or AML secondary to myelodysplastic syndrome (MDS) according to WHO classification;
  • * Subject is refractory to or relapsed after first-line AML therapy (with or without hematopoietic stem cell transplant )
  • * Subject is positive for FLT3 mutation in bone marrow or whole blood as determined by the central lab
  • * Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • * Subject is eligible for pre-selected salvage chemotherapy at the investigator's discretion
Exclusion Criteria
  • * Subject has received prior treatment with other FLT3 inhibitors
  • * Subject has AML that has relapsed after or is refractory to more than 1 line of therapy
  • * Subject has an active uncontrolled infection
  • * Subject is known to have human immunodeficiency virus infection
  • * Subject has any condition which, in the investigator's opinion, makes the subject unsuitable for study participation
HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML

Location Details

NCT05586074

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

China,

the First Affiliated Hospital,College of Medicine,Zhejiang University

Han Zhou, China,