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this study will explore the efficacy of maintenance SC cytarabine + venetoclax therapy as regard disease free survival (DFS) in AML fit patients who achieved CR after highly aggressive chemotherapy as bridge for BMT or if BMT will be delayed or canceled due to any other reason.
this study is a prospective,phase III , randomized ,open , interventional study include young fit patients who will receive maintenance venetoclax +subcutaneous cytarabine as bridge for BMT or if BMT will be delayed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | will receive SC cytarabine + venetoclax till bone marrow transplantation or for 12 cycles for patient will not undergo BMT , SC Cytarabine (20 mg) administrated on days 1-7 , Venetoclax (100 mg ) administrated on days 1-7 , Voriconazole 200 mg 1x2 administrated on days 1-7 + best supportive care BSC |
|
| Arm B | No Intervention | Patients Will receive Best supportive care( BSC )only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SC cytarabine +Venetoclax | Drug | SC Cytarabine (20 mg) administrated on days 1-7 ,,Venetoclax (100 mg ) administrated on days 1-7,,Voriconazole 200 mg 1x2 administrated on days , Best supportive care as needed . Up to 12 cycles or until patients undergo bone marrow transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival DFS | time from complet remission to relapse or death from any cause in AML fit patients receiving maintenance SC cytarabine plus venetoclax after intensive chemotherapy | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eman I Abdelshakour, Asst lect | Contact | +201063901450 | +201122103385 | Eman011065@med.sohag.edu.eg |
| Walaa G Mohamed, Lecturer | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Elsayed M Ali, Professor | Faculty of medicine sohag university | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sohag university hospital | Recruiting | Sohag | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 1. Papaemmanuil E, Gerstung M, Bullinger L, Gaidzik VI, Paschka P, Roberts ND, et al. Genomic classification and prognosis in acute myeloid leukemia. N Engl J Med. 2016;374:2209-21. 2. DiNardo CD, Erba HP, Freeman SD, Wei AH. Acute myeloid leukaemia. Lancet. 2023;401:2073-86. 3. Miranda-Filho A, Piñeros M, Ferlay J, et al: Epidemiological patterns of leukaemia in 184 countries: A population-based study. Lancet Haematol 5:e14-e24, 2018 |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
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this study is a prospective,phase III , randomized ,open , interventional study. double blind, placebo control clinical trial . Evaluating efficacy of maintenance venetoclax based therapy in Acute meyloid leukemia fit patients who acheived complete remission after standard induction and consolidation therapy.
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| Sohag university | Recruiting | Sohag | Egypt |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |