Acute Myeloid Leukemia Clinical Trial
Official title:
Combination of Brutons Tyrosine Kinase (BTK) Inhibitor Overcomes Drug-resistance in Refractory/Relapsed FLT3 Mutant Acute Myeloid Leukemia (AML)
Verified date | August 2018 |
Source | Nanfang Hospital of Southern Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Clinical efficacy of FLT3 inhibitors combining with chemotherapy is usually transient and followed by emergence of drug-resistance in FLT3-ITD mutant AML. BTK is reported to be a therapeutic target in this subtype leukemia. Our previous study showed inhibition of BTK onvercome drug-resistance to FLT3 inhibitors/chemotherapy in refractory/relapsed FLT3 mutant AML. In this prospective randomized controlled study, the efficacy and safety of combination of BTK inhibitor with chemotherapy with/without FLT3 inhibitor in refractory/relapsed FLT3 mutant AML are evaluated.
Status | Enrolling by invitation |
Enrollment | 122 |
Est. completion date | September 2023 |
Est. primary completion date | August 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 60 Years |
Eligibility |
Inclusion Criteria: Refractoty/relapsed FLT3-ITD mutation AML Age 14-60 Exclusion Criteria: Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) Patients with any conditions not suitable for the trial (investigators' decision) |
Country | Name | City | State |
---|---|---|---|
China | Department of Hematology,Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Nanfang Hospital of Southern Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CR rate | After the first and second cycle induction | ||
Primary | OS | 2 years | ||
Primary | DFS | 2 years |
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