RECRUITINGPhase 3INTERVENTIONAL
HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML
HEC73543 Versus Salvage Chemotherapy in Relapsed or Refractory FLT3-ITD Acute Myeloid Leukemia: a Multicenter, Open-label, Randomized Phase 3 Trial
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Subject is ≥ 18 years of age at the time of obtaining willing to sign a consent form.
- 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
Who Should NOT Join This Trial:
- 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 weakened immune system virus infection
- Subject has any condition which, in the investigator's opinion, makes the subject unsuitable for study participation
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Clifutinib
tablet, oral
DRUG
LoDAC
subcutaneous (SC) or intravenous (IV) injection
DRUG
Azacitidine
SC or IV
DRUG
Decitabine
IV
DRUG
Ara-C±IDA
SC and IV
DRUG
FLAG-IDA
SC and IV
Locations (1)
the First Affiliated Hospital,College of Medicine,Zhejiang University
Hanzhou, China