Status:
UNKNOWN
Combination of Sorafenib With Standard Therapy in Newly Diagnosed Adult CBF AML
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Collaborating Sponsors:
Guangzhou First People's Hospital
Guangzhou Panyu Central Hospital
Conditions:
Core Binding Factor Acute Myeloid Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Core-binding factor acute myeloid leukemia accounts for 10-15% of AML and is categorized as favorable-risk AML. However, the 5-year CIR was up to 40% in this group of patients. Emerging data show that...
Detailed Description
Core-binding factor acute myeloid leukemia is characterized by t(8;21) or inv(16) and accounts for 10-15% of AML. Because of the high CR rate of nearly 90% and a 5-year OS of almost 50%, CBF-AML is ca...
Eligibility Criteria
Inclusion
- Patients must have an unequivocal diagnosis of de novo-CBF AML, prior to start therapy, documented by rearrangement of Core Binding Factor (CBF) genes, namely RUNX1/RUNX1T1 and CBFB/MYH11.
- Age 18 to 65 years old with ECOG performance status 0-2.
- Sign informed consent form, have the ability to comply with study and follow-up procedures.
- Patients must have Total Bilirubin ≤ 1.5 x ULN, and AST or ALT ≤ 2.5 x ULN.
- Patients must have Serum Creatinine ≤ 1.5 x ULN.
- Women of child-bearing potential must have a negative pregnancy test before starting the protocol.
Exclusion
- Prior therapy for AML with the following exceptions:
- emergency leukapheresis
- emergency treatment for hyperleukocytosis with hydroxyurea for ≤ 7 days.
- Central nervous system involvement.
- Presence of any uncontrolled bacterial, viral or fungal infection.
- Known human immunodeficiency virus (HIV) positive.
- An active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection. Patients whose disease is controlled under antiviral therapy should not be excluded.
- Presence of other active malignancies.
- QTc \> 470 msec (Bazett formula) on screening ECG.
- Presence of significant uncontrolled or active cardiovascular disease, specifically including, but not restricted to:
- Myocardial infarction, unstable angina and/or congestive heart failure within 3 months prior to randomization
- History of clinically significant (as determined by the treating physician) atrial arrhythmia or any ventricular arrhythmia
- Uncontrolled hypertension
- Taking medications that are known to be associated with Torsades de Pointes.
- History of hypersensitivity to any drugs or metabolites of similar chemical classes as the study treatment.
- Intolerance to sorafenib, namely persistence of sorafenib-related adverse events despite supportive treatment, persistence or recurrence of adverse events after dose interruption or dose reduction of sorafenib, or both of these.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT05404516
Start Date
January 1 2020
End Date
December 31 2023
Last Update
June 3 2022
Active Locations (1)
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1
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515