Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2025-09-01
2027-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm A
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
SC cytarabine +Venetoclax
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
Arm B
Patients Will receive Best supportive care( BSC )only
No interventions assigned to this group
Interventions
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SC cytarabine +Venetoclax
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
60 Years
ALL
No
Sponsors
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Sohag University
OTHER
Responsible Party
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Eman Ibrahim Abdelshakour
Assistant lecturer
Principal Investigators
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Elsayed M Ali, Professor
Role: STUDY_DIRECTOR
Faculty of medicine sohag university
Locations
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Sohag university hospital
Sohag, , Egypt
Sohag university
Sohag, , Egypt
Countries
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Central Contacts
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Walaa G Mohamed, Lecturer
Role: CONTACT
Facility Contacts
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References
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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
Other Identifiers
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Soh-Med-25-9---3MD
Identifier Type: -
Identifier Source: org_study_id
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