INNOVATE: A Study of the Effectiveness of Venetoclax Tablets in Adult Acute Myeloid Leukemia Participants Ineligible for Standard Induction Therapy in Russian Federation

Sponsor

AbbVie (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04253314

Collaborator

(none)

Enrollment

Locations

37.2

Anticipated Duration (Months)

5.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia (AML)

Study Design

Study Type:

Observational

Actual Enrollment :

51 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Actual Study Start Date :

Mar 13, 2020

Anticipated Primary Completion Date :

Apr 20, 2023

Anticipated Study Completion Date :

Apr 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Venetoclax Participants Participants treated with Venetoclax in accordance with approved local label. Decision to treat with Venetoclax was made prior to offering participation in this study.

Outcome Measures

Primary Outcome Measures

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

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.
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 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).
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.
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).
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 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 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 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.
Percentage of participants with dose interruptions [Approximately 18 months]
Percentage of participants with dose interruptions
Percentage of participants taking concimtant CYP3A medications [Approximately 18 months]
Percentage of participants taking concimtant CYP3A medications while treated with Venetoclax.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moscow State budget healthcare /ID# 218569	Moscow	Moskva	Russian Federation	125284
2	Saratov State Medical University n.a. V.I. Razumovskiy /ID# 226059	Saratov	Saratovskaya Oblast	Russian Federation	410012
3	Hematology department State budgetary health care institution Volgograd region /ID# 229813	Volgograd	Volgogradskaya Oblast	Russian Federation	400138
4	Regional Clinical Hospital of Irkutsk /ID# 218570	Irkutsk		Russian Federation	664049
5	Clinical Medico-Sanitary Unit #1 /ID# 222502	Perm		Russian Federation	614077
6	Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 229812	Sankt-Peterburg		Russian Federation	191024
7	Almazov National Medical Research Centre /ID# 218571	Sankt-Peterburg		Russian Federation	197341
8	R.M.Gorbacheva Research Institute of Paediatric Oncology, Haematology and Transp /ID# 224831	St. Petersburg		Russian Federation	197101
9	Republican Hospital #1 - National Center of Medicine of Sakha (Yakutia) /ID# 224830	Yakutsk		Russian Federation	677008
10	Sakhalin Regional Clinical Hospital /ID# 222501	Yuzhno-Sakhalinsk		Russian Federation	693004