Acute Myeloid Leukemia (AML)INNOVATENCT04253314
A Study of the Effectiveness of Venetoclax Tablets in Adult Acute Myeloid Leukemia Participants Ineligible for Standard Induction Therapy in Russian Federation
An observational study of Acute Myeloid Leukemia (AML), run by AbbVie at 10 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- How many people
- 51 participants
- Where
- 10 sitesRussia
- Study dates
- 13 Mar 2020to 16 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with acute myeloid leukemia (AML) treated with Venetoclax per approved local label in Russian Federation.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Russia10 sites
Regional Clinical Hospital of Irkutsk /ID# 218570
Irkutsk, 664049
Moscow State budget healthcare /ID# 218569
Moscow, Moscow, 125284
Clinical Medico-Sanitary Unit #1 /ID# 222502
Perm, 614077
Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 229812
Saint Petersburg, 191024
R.M.Gorbacheva Research Institute of Paediatric Oncology, Haematology and Transp /ID# 224831
Saint Petersburg, 197101
Almazov National Medical Research Centre /ID# 218571
Saint Petersburg, 197341
Saratov State Medical University n.a. V.I. Razumovskiy /ID# 226059
Saratov, Saratov Oblast, 410012
Hematology department State budgetary health care institution Volgograd region /ID# 229813
Volgograd, Volgograd Oblast, 400138
Republican Hospital #1 - National Center of Medicine of Sakha (Yakutia) /ID# 224830
Yakutsk, 677008
Sakhalin Regional Clinical Hospital /ID# 222501
Yuzhno-Sakhalinsk, 693004
About this study
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)
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.
Read more
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.
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- Acute Myeloid Leukemia (AML), Venetoclax, Venclexta
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Defined as the time (in days) between the date of first Venetoclax intake to date of death.
Measured: Approximately 18 months
Secondary outcomes (16)
Overall Response Rate
Defined as the percentage of participants with either complete response (CR) or complete response with incomplete hematological recovery (CRi) according to physician's assessment.
Measured: Approximately 18 months
Best Overall Response Rate
Defined as the percentage of participants with either CR or CRi according to physician's assessment during Venetoclax treatment.
Measured: Approximately 18 months
Best complete Remission
Defined as the percentage of participants with CR according to physician's assessment during Venetoclax treatment.
Measured: Approximately 18 months
Time to First Response
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).
Measured: Approximately 18 months
Time to Best Response to Treatment
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.
Measured: Approximately 18 months
Duration of Response (DOR)
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.
Measured: Approximately 18 months
Event-Free Survival (EFS)
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).
Measured: Approximately 18 months
Relapse-Free Survival (RFS)
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.
Measured: Approximately 18 months
Time to Transfusion Independence
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.
Measured: Approximately 18 months
Percentage of participants treated with Venetoclax in combination with hypomethylating agents (HMAs)
Defined as the percentage of participants treated with Venetoclax in combination with hypomethylating agents (HMAs).
Measured: Approximately 18 months
Percentage of participants treated with Venetoclax in combination with low dose cytarabine (LDAC)
Defined as the percentage of participants treated with Venetoclax in combination with low dose cytarabine (LDAC).
Measured: Approximately 18 months
Percentage of participants treated with Venetoclax in combination with other therapeutic agents
Defined as the percentage of participants treated with Venetoclax in combination with other therapeutic agents
Measured: Approximately 18 months
Percentage of participants with dose modifications
Percentage of participants with dose modifications.
Measured: Approximately 18 months
Percentage of participants with dose interruptions
Percentage of participants with dose interruptions
Measured: Approximately 18 months
Percentage of participants taking concimtant CYP3A medications
Percentage of participants taking concimtant CYP3A medications while treated with Venetoclax.
Measured: Approximately 18 months
Number of participants with adverse events
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.
Measured: Approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start13 Mar 2020
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253314
- Sponsor's protocol ID
- P20-147
- Acronym
- INNOVATE
- Status last verified
- Nov 2024
- First submitted
- 31 Jan 2020
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04253314
- Acronym / sponsor ID
- INNOVATE / P20-147
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- Acute Myeloid Leukemia (AML), Venetoclax, Venclexta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with acute myeloid leukemia (AML) treated with Venetoclax per approved local label in Russian Federation.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival
Time frame: Approximately 18 months
Defined as the time (in days) between the date of first Venetoclax intake to date of death.
16 secondary outcomes
Overall Response Rate
Time frame: Approximately 18 months
Best Overall Response Rate
Time frame: Approximately 18 months
Best complete Remission
Time frame: Approximately 18 months
Time to First Response
Time frame: Approximately 18 months
Time to Best Response to Treatment
Time frame: Approximately 18 months
Duration of Response (DOR)
Time frame: Approximately 18 months
Event-Free Survival (EFS)
Time frame: Approximately 18 months
Relapse-Free Survival (RFS)
Time frame: Approximately 18 months
Time to Transfusion Independence
Time frame: Approximately 18 months
Percentage of participants treated with Venetoclax in combination with hypomethylating agents (HMAs)
Time frame: Approximately 18 months
Percentage of participants treated with Venetoclax in combination with low dose cytarabine (LDAC)
Time frame: Approximately 18 months
Percentage of participants treated with Venetoclax in combination with other therapeutic agents
Time frame: Approximately 18 months
Percentage of participants with dose modifications
Time frame: Approximately 18 months
Percentage of participants with dose interruptions
Time frame: Approximately 18 months
Percentage of participants taking concimtant CYP3A medications
Time frame: Approximately 18 months
Number of participants with adverse events
Time frame: Approximately 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia (AML), run by AbbVie at 10 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Approximately 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.