Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253314
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Acute Myeloid Leukemia (AML)

Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 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 : March 13, 2020
Estimated Primary Completion Date : October 17, 2023
Estimated Study Completion Date : October 17, 2023


Group/Cohort
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 concomitant CYP3A medications [ Time Frame: Approximately 18 months ]
    Percentage of participants taking concomitant 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult participants with acute myeloid leukemia (AML) treated with Venetoclax per approved local label in Russian Federation.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253314


Contacts
Layout table for location contacts
Contact: Kseniya Arkhipova +7 495 258 4270 ksenia.arkhipova@abbvie.com

Locations
Layout table for location information
Russian Federation
Moscow State budget healthcare institution City Clinical Hospital n.a. Botkin /ID# 218569 Recruiting
Moscow, Moskva, Russian Federation, 125284
Almazov National Medical Research Centre /ID# 218571 Not yet recruiting
Saint Petersburg, Sankt-Peterburg, Russian Federation, 197341
GBUZ, Irkutsk Regional Clinic Hospital /ID# 218570 Recruiting
Irkutsk, Russian Federation, 664003
Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
Study Director: AbbVie Inc. AbbVie
Additional Information:
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04253314    
Other Study ID Numbers: P20-147
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Acute Myeloid Leukemia (AML)
Venetoclax
Venclexta
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms