Acute Myeloid Leukemia Clinical Trial
Official title:
Sorafenib for Prophylaxis of Leukemia Relapse in Allogeneic Hematopoietic Stem Cell Transplant Recipients With FLT3-ITD Positive Acute Myeloid Leukemia
Verified date | June 2015 |
Source | Nanfang Hospital of Southern Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the efficacy of sorafenib for prophylaxis of leukemia relapse in allogeneic stem cell transplant (Allo-HSCT) recipients with FLT3-ITD positive acute myeloid leukemia (AML).
Status | Completed |
Enrollment | 202 |
Est. completion date | August 10, 2019 |
Est. primary completion date | July 21, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - FLT3-ITD Positive AML - Allo-HSCT Recipients Exclusion Criteria: - cardiac dysfunction (particularly congestive heart failure) - hepatic abnormalities (bilirubin = 3 mg/dL, aminotransferase> 2 times the upper limit of normal) - renal dysfunction (creatinine clearance rate < 30 mL/min) - 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 | First People's Hospital of Chenzhou, Peking University People's Hospital, The First Affiliated Hospital of Guangzhou Medical University, Third Affiliated Hospital, Sun Yat-Sen University, Xiangya Hospital of Central South University, Zhujiang Hospital |
China,
Metzelder SK, Schroeder T, Finck A, Scholl S, Fey M, Götze K, Linn YC, Kröger M, Reiter A, Salih HR, Heinicke T, Stuhlmann R, Müller L, Giagounidis A, Meyer RG, Brugger W, Vöhringer M, Dreger P, Mori M, Basara N, Schäfer-Eckart K, Schultheis B, Baldus C, Neubauer A, Burchert A. High activity of sorafenib in FLT3-ITD-positive acute myeloid leukemia synergizes with allo-immune effects to induce sustained responses. Leukemia. 2012 Nov;26(11):2353-9. doi: 10.1038/leu.2012.105. Epub 2012 Apr 16. — View Citation
Ravandi F, Cortes JE, Jones D, Faderl S, Garcia-Manero G, Konopleva MY, O'Brien S, Estrov Z, Borthakur G, Thomas D, Pierce SR, Brandt M, Byrd A, Bekele BN, Pratz K, Luthra R, Levis M, Andreeff M, Kantarjian HM. Phase I/II study of combination therapy with sorafenib, idarubicin, and cytarabine in younger patients with acute myeloid leukemia. J Clin Oncol. 2010 Apr 10;28(11):1856-62. doi: 10.1200/JCO.2009.25.4888. Epub 2010 Mar 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of leukemia relapse | 1 year | ||
Secondary | Overall survival | 3 year | ||
Secondary | leukemia-free survival | 3 year | ||
Secondary | Incidence of side effect of sorafenib | 6 months |
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