Clinical trial NCT04253314: A Study of the Effectiveness of Venetoclax Tablets in Adult Acute Myeloid Leukemia Participants Ineligible for Standard Induction Therapy in Russian Federation
Official title: Prospective Multi-Center Observational Study to Assess Effectiveness of Venclexta (Venetoclax) in Acute Myeloid Leukemia (AML) Patients Ineligible for Standard Induction Therapy in Routine Clinical Practice in Russian Federation (INNOVATE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia (AML)
Keywords: Acute Myeloid Leukemia (AML)
Venetoclax
Venclexta
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with acute myeloid leukemia (AML) treated with Venetoclax per approved local label in Russian Federation.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Overall Survival
timeFrame: Approximately 18 months
Secondary outcomes:
measure: Overall Response Rate
timeFrame: Approximately 18 months
measure: Best Overall Response Rate
timeFrame: Approximately 18 months
measure: Best complete Remission
timeFrame: Approximately 18 months
measure: Time to First Response
timeFrame: Approximately 18 months
measure: Time to Best Response to Treatment
timeFrame: Approximately 18 months
measure: Duration of Response (DOR)
timeFrame: Approximately 18 months
measure: Event-Free Survival (EFS)
timeFrame: Approximately 18 months
measure: Relapse-Free Survival (RFS)
timeFrame: Approximately 18 months
measure: Time to Transfusion Independence
timeFrame: Approximately 18 months
measure: Percentage of participants treated with Venetoclax in combination with hypomethylating agents (HMAs)
timeFrame: Approximately 18 months
measure: Percentage of participants treated with Venetoclax in combination with low dose cytarabine (LDAC)
timeFrame: Approximately 18 months
measure: Percentage of participants treated with Venetoclax in combination with other therapeutic agents
timeFrame: Approximately 18 months
measure: Percentage of participants with dose modifications
timeFrame: Approximately 18 months
measure: Percentage of participants with dose interruptions
timeFrame: Approximately 18 months
measure: Percentage of participants taking concimtant CYP3A medications
timeFrame: Approximately 18 months
measure: Number of participants with adverse events
timeFrame: Approximately 18 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow State budget healthcare /ID# 218569
state: Moskva
city: Saratov
country: Russian Federation
facility: Saratov State Medical University n.a. V.I. Razumovskiy /ID# 226059
state: Saratovskaya Oblast
city: Volgograd
country: Russian Federation
facility: Hematology department State budgetary health care institution Volgograd region /ID# 229813
state: Volgogradskaya Oblast
city: Irkutsk
country: Russian Federation
facility: Regional Clinical Hospital of Irkutsk /ID# 218570
city: Perm
country: Russian Federation
facility: Clinical Medico-Sanitary Unit #1 /ID# 222502
city: Sankt-Peterburg
country: Russian Federation
facility: Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 229812
city: Sankt-Peterburg
country: Russian Federation
facility: Almazov National Medical Research Centre /ID# 218571
city: St. Petersburg
country: Russian Federation
facility: R.M.Gorbacheva Research Institute of Paediatric Oncology, Haematology and Transp /ID# 224831
city: Yakutsk
country: Russian Federation
facility: Republican Hospital #1 - National Center of Medicine of Sakha (Yakutia) /ID# 224830
city: Yuzhno-Sakhalinsk
country: Russian Federation
facility: Sakhalin Regional Clinical Hospital /ID# 222501
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: