Bcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated AML
NCT ID: NCT05053425
Last Updated: 2022-04-26
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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UNKNOWN
NA
30 participants
INTERVENTIONAL
2021-10-20
2023-03-18
Brief Summary
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Detailed Description
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regimen A: the first two cycles: venetoclax 400mg, d1-7/14, po; cladribine 5mg/m2, d1-3, ivgtt; cytarabine 10mg/m2, q12h, d1-10, sc; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; regimen B: the first two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 100mg/m2, d1-5/7, ivgtt; idarubicin 8mg/m2, d1-2/3, ivgtt; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; If the patient's ECOG performance status ≥2, the reduction of regimen IA(cytarabine+idarubicin)was 5+2. Maintenance therapy: azacytidine 75mg/m2, d1-7, sc.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Venetoclax group
Induction therapy: venetoclax d1 100mg, d2 200mg, d3-28 400mg, po; azacytidine 75mg/m2, d1-7, sc.
Consolidation therapy: Regimen A or B was chosen according to the wishes of the patients. In addition, venetoclax was used for 14 days for positive minimal residual disease(MRD) and 7 days for MRD negative.
regimen A: the first two cycles: venetoclax 400mg, d1-7/14, po; cladribine 5mg/m2, d1-3, ivgtt; cytarabine 10mg/m2, q12h, d1-10, sc; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; regimen B: the first two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 100mg/m2, d1-5/7, ivgtt; idarubicin 8mg/m2, d1-2/3, ivgtt; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; If the patient's ECOG performance status ≥2,the reduction of regimen IA(cytarabine+idarubicin)was 5+2.
Maintenance therapy: azacytidine 75mg/m2, d1-7, sc.
Venetoclax
given po.
Azacitidine
given sc.
Cladribine
given ivgtt.
Cytarabine
given sc or ivgtt.
Idarubicin
given ivgtt.
Interventions
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Venetoclax
given po.
Azacitidine
given sc.
Cladribine
given ivgtt.
Cytarabine
given sc or ivgtt.
Idarubicin
given ivgtt.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants are ineligible for induction regimen;
3. The Eastern Cooperative Oncology Group (ECOG) performance status is 0-3;
4. The patients and their families agree and sign the informed consent form.
Exclusion Criteria
2. Infiltration of the central nervous system;
3. Drugs use history affecting CYP3A within 7 days before enrollment;
4. participants considered by the investigator to be unsuitable for inclusion.
60 Years
ALL
No
Sponsors
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LanZhou University
OTHER
Responsible Party
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Long Zhao
Doctor-in-charge, Master of Medicine
Principal Investigators
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Long Zhao, M.M.
Role: PRINCIPAL_INVESTIGATOR
The First Hospital of Lanzhou University,Lanzhou,Gansu,China
Locations
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Long Zhao
Lanzhou, Gansu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ChiCTR2100045330
Identifier Type: REGISTRY
Identifier Source: secondary_id
CSBCL2
Identifier Type: -
Identifier Source: org_study_id
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