A Phase 2/3 interventional study of Venetoclax and Homoharringtonine in Acute Myeloid Leukemia, sponsored by The First Affiliated Hospital of Soochow University. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-04-07.
Sponsored by The First Affiliated Hospital of Soochow University · Phase 2/3, Interventional, and Treatment
This study aims to evaluate the efficacy and safety of venetoclax combined with homoharringtonine and cytarabine in the treatment of newly diagnosed acute myeloid leukemia.
This is a phase II/III study that seeks to treat patients ages 18-60 who have acute myeloid leukemia but have never been treated before. In order to improve the outcome of patients with primary AML, venetoclax combined with homoharringtonine and cytarabine was applied in the treatment of primary AML. This study aims to evaluate the efficacy and safety of venetoclax in combination with homoharringtonine and cytarabine in newly diagnosed subjects with AML.Depending on the level of recovery, patients will either be forced to come off study or have the option to continue the medication, receive maintenance therapy, or pursue an allogeneic stem cell transplant. After completion of study treatment, participants are followed up every 3 to 6 months for up to 2 years.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 60 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.
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Exclusion Criteria:
All recipients in this arm received Venetoclax, Homoharringtonine and Cytarabine. Venetoclax was uesd as 100 mg on day 1, 200 mg on day 2, 400mg from day-3 to day-28. Homoharringtonine was uesd as 1 mg/m2 qd from day-1 to day-5. Cytarabine was uesd as 100 mg/m2 qd from day-1 to day-5.
Drug: Venetoclax · Drug: Homoharringtonine · Drug: Cytarabine
Starting on day 1, venetoclax will be dose escalated to a target dose of 600 mg in the following manner: 100 mg on day 1, 200 mg on day 2 and 400 mg on day 3. The patient then continues to take the 400mg dose for the remainder of the 28 day cycle. Each dose of venetoclax will be self-administered with approximately 240 mL of water within 30 minutes after the completion of a meal, preferably breakfast. The dose should be administered at the same time each day.
Also known as: VEN
On day 1, homoharringtonine 1 mg/m2 IV will be given, and will continue for 5 days.
Also known as: HHT
On day 1, cytarabine 100 mg/m2 IV will be given, and will continue for 5 days.
Overall response rate (ORR)
Defined as complete response (CR) + CR with incomplete blood count recovery (CRi) + morphologic leukemia-free state (MLFS) + partial response (PR).
Time frame: 28 days after study treatment
Rate of Participants With Adverse Events
Percentage of Participants with 3 or 4 grade Adverse Events reported through 28 days post study medication administration.
Time frame: Through 28 days post study medication administration
Event-free survival
Defined as the number of days from the date of treatment initiation (i.e., course 1 day 1) to the date of documented treatment failure, relapses from CR, or death from any cause, whichever occurs first. Will be calculated for all patients. Estimated using Kaplan-Meier method. Log-rank tests will be used to compare among subgroups of patients.
Time frame: Through study completion, up to 3 years
Overall survival
Estimated using Kaplan-Meier method. Log-rank tests will be used to compare among subgroups of patients.
Time frame: Through study completion, up to 3 years
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The First Affiliated Hospital of Soochow University