A Study of the Effectiveness of Venetoclax Tablets in Adult Acute Myeloid Leukemia Participants Ineligible for Standard Induction Therapy in Russian Federation
- Conditions
- Acute Myeloid Leukemia (AML)
- Registration Number
- NCT04253314
- Lead Sponsor
- AbbVie
- Brief Summary
Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well Venetoclax works to treat AML in adult participants who are ineligible for standard induction therapy in Russian Federation.
Venetoclax is a drug approved to treat Acute Myeloid Leukemia. All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a diagnosis of AML who are ineligible for standard induction therapy will be enrolled. Around 50 participants will be enrolled in the study in approximately 15 sites in Russian Federation.
Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 18 months.
There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice (approximately every 3 months) and participants will be followed for 18 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- Newly diagnosed acute myeloid leukemia (AML) (de novo or secondary) and eligible to receive Venetoclax as per Russian Ministry of Health label
- Ineligible for standard induction therapy with cytarabine and anthracycline
- Eastern Cooperative Oncology Group (ECOG) score >2
- White blood cell counts <25 x 109 per liter
- Started Venetoclax within 4 weeks of enrolling in study
- Acute promyelocytic leukemia
- Contraindications to Venetoclax as listed on the approved local label in Russian Federation
- Neuroleukemia - active central nervous system (CNS) involvement
- Participation in a clinical trial with an investigational drug for AML within 30 days prior to Venetoclax treatment initiation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival Approximately 18 months Defined as the time (in days) between the date of first Venetoclax intake to date of death.
- Secondary Outcome Measures
Name Time Method Percentage of participants with dose interruptions Approximately 18 months Percentage of participants with dose interruptions
Best Overall Response Rate Approximately 18 months Defined as the percentage of participants with either CR or CRi according to physician's assessment during Venetoclax treatment.
Best complete Remission Approximately 18 months Defined as the percentage of participants with CR according to physician's assessment during Venetoclax treatment.
Time to Best Response to Treatment Approximately 18 months Defined as the time (in weeks) between the date of first Venetoclax intake and the date of hte assessment having documented the best response among CR, CRi, and MLSF.
Time to First Response Approximately 18 months Defined as the time (in weeks) between the date of first Venetoclax intake to first response, among CR, CRi, and morphologic leukemia free state (MLSF).
Relapse-Free Survival (RFS) Approximately 18 months Defined as the time between the date of CR and the date of the first assessment having documented disease progression or death from any cause.
Time to Transfusion Independence Approximately 18 months Defined as the time (in weeks) between the date of first Venetoclax intake and the absence of any red blood cell (RBC) or platelet transfusion during any consecutive 8 weeks during the treatment period.
Percentage of participants treated with Venetoclax in combination with low dose cytarabine (LDAC) Approximately 18 months Defined as the percentage of participants treated with Venetoclax in combination with low dose cytarabine (LDAC).
Percentage of participants taking concimtant CYP3A medications Approximately 18 months Percentage of participants taking concimtant CYP3A medications while treated with Venetoclax.
Duration of Response (DOR) Approximately 18 months Defined as the time (in weeks) between the date of the first assessment documenting the response to Venetoclax (either CR, CRi, or MLSF) and the date of the first assessment having documented the progression.
Event-Free Survival (EFS) Approximately 18 months Defined as the time (in weeks) between the date of first Venetoclax intake and the date of the first assessment having documented disease progression (primary refractory disease, or relapse from CR, CRi, or death from any cause).
Percentage of participants treated with Venetoclax in combination with hypomethylating agents (HMAs) Approximately 18 months Defined as the percentage of participants treated with Venetoclax in combination with hypomethylating agents (HMAs).
Percentage of participants treated with Venetoclax in combination with other therapeutic agents Approximately 18 months Defined as the percentage of participants treated with Venetoclax in combination with other therapeutic agents
Percentage of participants with dose modifications Approximately 18 months Percentage of participants with dose modifications.
Number of participants with adverse events Approximately 18 months An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Overall Response Rate Approximately 18 months Defined as the percentage of participants with either complete response (CR) or complete response with incomplete hematological recovery (CRi) according to physician's assessment.
Trial Locations
- Locations (10)
Hematology department State budgetary health care institution Volgograd region /ID# 229813
🇷🇺Volgograd, Volgogradskaya Oblast, Russian Federation
Regional Clinical Hospital of Irkutsk /ID# 218570
🇷🇺Irkutsk, Russian Federation
Clinical Medico-Sanitary Unit #1 /ID# 222502
🇷🇺Perm, Russian Federation
Almazov National Medical Research Centre /ID# 218571
🇷🇺Sankt-Peterburg, Russian Federation
Moscow State budget healthcare /ID# 218569
🇷🇺Moscow, Moskva, Russian Federation
Saratov State Medical University n.a. V.I. Razumovskiy /ID# 226059
🇷🇺Saratov, Saratovskaya Oblast, Russian Federation
R.M.Gorbacheva Research Institute of Paediatric Oncology, Haematology and Transp /ID# 224831
🇷🇺St. Petersburg, Russian Federation
Republican Hospital #1 - National Center of Medicine of Sakha (Yakutia) /ID# 224830
🇷🇺Yakutsk, Russian Federation
Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 229812
🇷🇺Sankt-Peterburg, Russian Federation
Sakhalin Regional Clinical Hospital /ID# 222501
🇷🇺Yuzhno-Sakhalinsk, Russian Federation