Acute Myeloid LeukemiaNCT06362031
A Study to Explore Treatment Patterns, Treatment Outcomes, Healthcare Resource Utilization in Adult Participants With Acute Myeloid Leukemia (AML) Receiving Venetoclax Through Chart Review
An observational study of Acute Myeloid Leukemia, run by AbbVie.
Trial summary
Acute myeloid leukemia (AML), also referred to as acute myelogenous leukemia or acute non-lymphocytic leukemia, is a relatively rare, yet aggressive, type of cancer. This study will evaluate treatment patterns, treatment outcomes, healthcare resource utilization in adult participants with AML receiving venetoclax. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 30 Apr 2024
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Participants with Acute Myeloid Leukemia (AML) being treated with venetoclax.
Who may be able to join
- The participant received a diagnosis for acute myeloid leukemia (AML).
- The participant was initiated on the studied line of therapy for previously untreated AML, as noted in the protocol.
- The participant was treated with the studied line of therapy at least 28 days prior to date of data collection.
- Information on the participant's treatments, selected (or important) clinical characteristics, and outcomes is available from the start of the studied line of therapy onwards.
Who cannot join
- The participant received the studied line of therapy as part of a clinical trial.
- Participant received prior lines of therapy for AML.
- The participant has a history of malignancies within 2 years prior to the studied line of therapy, other than AML, and with the exception of what is noted in the protocol.
About this study
Official title: A Center-Based Chart Review Study to Assess Treatment Outcomes of Venetoclax for the Treatment of Acute Myeloid Leukemia (AML)
Acute myeloid leukemia (AML), also referred to as acute myelogenous leukemia or acute non-lymphocytic leukemia, is a relatively rare, yet aggressive, type of cancer. This study will evaluate treatment patterns, treatment outcomes, healthcare resource utilization in adult participants with AML receiving venetoclax.
Data from up to 700 participants will be collected. No participants will be enrolled in this study.
Read more
Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the observation period is up to 10 months.
There is no additional burden for participants in this trial. All visits must be completed prior to data extraction and participants will be followed for up to 10 months.
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, Cancer, Venetoclax: Venclyxto, ABT-199
- Medical subject headings
- Leukemia, Myeloid, Acute, Neoplasms
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 |
|---|---|---|
| Participants Receiving Venetoclax | Participants with AML receiving venetoclax undergoing chart review. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS will be measured as the number of days between the initiation of the studied line of therapy and death.
Measured: Up to 10 Months
Event-free survival (EFS)
EFS will be measured as the number of days between the initiation of the studied line of therapy and disease progression, or refractory disease, or death.
Measured: Up to 10 Months
Percentage of Participants Achieving Best Overall Response
Physician-reported best response achieved from initiation of the studied line of therapy until the earliest of disease progression, refractory disease, relapse, switch to a new line of therapy, or end of follow-up or death.
Measured: Up to 10 Months
Duration of Response (DoR)
DoR is is defined as complete remission (CR), complete remission with incomplete marrow recovery (CRi), complete remission with partial hematologic recovery (CRh), morphologic leukemia-free state (MLFS); in days.
Measured: Up to 10 Months
Percentage of Participants with Transfusion Independence (TI)
TI from initiation of the studied line of therapy until disease progression, refractory disease, relapse, or switch to a new line of therapy.
Measured: Up to 10 Months
Secondary outcomes (1)
Number of Participants with Healthcare Resource Utilization (HRU)
HRU is measured from initiation of the studied line of therapy until physician recorded disease progression, refractory disease, relapse, or switch to a new line of therapy.
Measured: Up to 10 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 Jun 2023 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Why it stopped: Strategic considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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
- Retrospective
- Enrolment
- 0 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
- NCT06362031
- Sponsor's protocol ID
- H18.Oncology.12-SR1812
- Status last verified
- Apr 2024
- First submitted
- 31 May 2023
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Center-Based Chart Review Study to Assess Treatment Outcomes of Venetoclax for the Treatment of Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT06362031
- Acronym / sponsor ID
- H18.Oncology.12-SR1812
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, Cancer, Venetoclax: Venclyxto, ABT-199
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Strategic considerations
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 12 Apr 2024 (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), also referred to as acute myelogenous leukemia or acute non-lymphocytic leukemia, is a relatively rare, yet aggressive, type of cancer. This study will evaluate treatment patterns, treatment outcomes, healthcare resource utilization in adult participants with AML receiving venetoclax.
Data from up to 700 participants will be collected. No participants will be enrolled in this study.
Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the observation period is up to 10 months.
There is no additional burden for participants in this trial. All visits must be completed prior to data extraction and participants will be followed for up to 10 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Receiving Venetoclax | – | –Participants with AML receiving venetoclax undergoing chart review. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Participants with Acute Myeloid Leukemia (AML) being treated with venetoclax.
Key inclusion criteria (4 listed)
- The participant received a diagnosis for acute myeloid leukemia (AML).
- The participant was initiated on the studied line of therapy for previously untreated AML, as noted in the protocol.
- The participant was treated with the studied line of therapy at least 28 days prior to date of data collection.
- Information on the participant's treatments, selected (or important) clinical characteristics, and outcomes is available from the start of the studied line of therapy onwards.
Key exclusion criteria (3 listed)
- The participant received the studied line of therapy as part of a clinical trial.
- Participant received prior lines of therapy for AML.
- The participant has a history of malignancies within 2 years prior to the studied line of therapy, other than AML, and with the exception of what is noted in the protocol.
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 (OS)
Time frame: Up to 10 Months
OS will be measured as the number of days between the initiation of the studied line of therapy and death.
Event-free survival (EFS)
Time frame: Up to 10 Months
EFS will be measured as the number of days between the initiation of the studied line of therapy and disease progression, or refractory disease, or death.
Percentage of Participants Achieving Best Overall Response
Time frame: Up to 10 Months
Physician-reported best response achieved from initiation of the studied line of therapy until the earliest of disease progression, refractory disease, relapse, switch to a new line of therapy, or end of follow-up or death.
Duration of Response (DoR)
Time frame: Up to 10 Months
DoR is is defined as complete remission (CR), complete remission with incomplete marrow recovery (CRi), complete remission with partial hematologic recovery (CRh), morphologic leukemia-free state (MLFS); in days.
Percentage of Participants with Transfusion Independence (TI)
Time frame: Up to 10 Months
TI from initiation of the studied line of therapy until disease progression, refractory disease, relapse, or switch to a new line of therapy.
1 secondary outcome
Number of Participants with Healthcare Resource Utilization (HRU)
Time frame: Up to 10 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by AbbVie.
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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 (OS) (time frame: Up to 10 Months). The study lists 5 primary outcomes in all. 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 12 Apr 2024.