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NCT Number: NCT04253314

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Moscow State budget healthcare /ID# 218569, Moscow, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall Survival

    Time frame: Approximately 18 months

    Defined as the time (in days) between the date of first Venetoclax intake to date of death.

Secondary outcomes

  1. Overall Response Rate

    Time frame: 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.

  2. Best Overall Response Rate

    Time frame: Approximately 18 months

    Defined as the percentage of participants with either CR or CRi according to physician's assessment during Venetoclax treatment.

  3. Best complete Remission

    Time frame: Approximately 18 months

    Defined as the percentage of participants with CR according to physician's assessment during Venetoclax treatment.

  4. Time to First Response

    Time frame: 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).

  5. Time to Best Response to Treatment

    Time frame: 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.

  6. Duration of Response (DOR)

    Time frame: 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.

  7. Event-Free Survival (EFS)

    Time frame: 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).

  8. Relapse-Free Survival (RFS)

    Time frame: 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.

  9. Time to Transfusion Independence

    Time frame: 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.

  10. Percentage of participants treated with Venetoclax in combination with hypomethylating agents (HMAs)

    Time frame: Approximately 18 months

    Defined as the percentage of participants treated with Venetoclax in combination with hypomethylating agents (HMAs).

  11. Percentage of participants treated with Venetoclax in combination with low dose cytarabine (LDAC)

    Time frame: Approximately 18 months

    Defined as the percentage of participants treated with Venetoclax in combination with low dose cytarabine (LDAC).

  12. Percentage of participants treated with Venetoclax in combination with other therapeutic agents

    Time frame: Approximately 18 months

    Defined as the percentage of participants treated with Venetoclax in combination with other therapeutic agents

  13. Percentage of participants with dose modifications

    Time frame: Approximately 18 months

    Percentage of participants with dose modifications.

  14. Percentage of participants with dose interruptions

    Time frame: Approximately 18 months

    Percentage of participants with dose interruptions

  15. Percentage of participants taking concimtant CYP3A medications

    Time frame: Approximately 18 months

    Percentage of participants taking concimtant CYP3A medications while treated with Venetoclax.

  16. Number of participants with adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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)

Acronym: INNOVATE

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2020
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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