Trial · NCT02993523
A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy
NCT02993523, Phase 3, Active not recruiting, AbbVie; results first posted 2023-01-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy. Trials, record NCT02993523. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02993523
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy
- NCT number
- NCT02993523
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 443 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Acute Myeloid Leukemia (AML)
- Interventions
- Azacitidine, Venetoclax, Placebo
- First posted
- 2016-12-15
- Last updated
- 2026-06-11
- Other registries' IDs
- eudract:2016-001466-28
- Results first posted
- 2023-01-27
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From the study start up to death or alive or lost to follow-up (up to approximately 4.8 years; data cut off date: 1 December 2021) | OS is defined as the number of days from the date of randomization to the date of death. Log rank test was used to compare the OS distribution between two treatment arms. Cox regression was used to report the hazard ratio. |
| Primary | Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi) | From the study start up to death (up to approximately 4.8 years; data cut-off date: 1 December 2021) | CR and CRi was calculated based on current International Working Group (IWG) criteria. CR is defined as absolute neutrophil count \>10\^3/ microliter (mcL), platelets \>10\^5/mcL, red cell transfusion independence, and bone marrow with \<5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophils of ≤10\^3/mcL or platelets ≤10\^5/mcL. Percentages are rounded off to whole number at the nearest decimal. |
| Secondary | Event-free Survival (EFS) | Measured up to 2 years after the last participant is randomized | EFS will be defined as the number of days from randomization to the date of progressive disease, relapse from CR or CRi, treatment failure or death from any cause. |
| Secondary | Global Health Status/Quality of Life (GHS/QoL) | Measured at participant's Day 1 of Cycle 1 (each cycle is 28 days) and at Day 1 of every Cycle thereafter for up to 2 years following the last subject last visit | Improvement in GHS/QoL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30). |
| Secondary | Percentage of Participants Achieving Composite Complete Remission (CR or CRi) | Up to 6 months after the first 225 participants are randomized | This will be calculated based on current International Working Group (IWG) criteria. CR is defined as absolute neutrophil count \> 10\^3/mcL, platelets \> 10\^5/mcL, red cell transfusion independence, and bone marrow with \< 5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophils of \<= 10\^3/mcL or platelets \<= 10\^5/mcL. |
| Secondary | Complete Remission or Complete Remission With Partial Hematologic Recovery Rate (CR+CRh) | Measured up to 2 years after the last participant is randomized | A response of CRh is defined as Bone marrow with \<5% blasts, peripheral blood neutrophil count \>0.5\*10\^3/mcL and peripheral blood platelet count \>0.5\*10\^5/mcL. |
| Secondary | Post Baseline Transfusion Independence Rate | Measured up to 2 years after the last participant is randomized | Transfusion Independence is defined as a period of 56 days with no transfusion between first dose of study drug and the last dose of study drug + 30 days. The rate of conversion for red blood cells (RBC) and platelets is defined as percentage of participants being post-baseline transfusion independent from baseline transfusion dependence. |
| Secondary | Complete Remission (CR) Rate | Measured up to 2 years after the last participant is randomized | The percentage of participants with complete remission (CR) will be calculated based on the modified IWG criteria for AML. |
| Secondary | Fatigue/Quality of Life (QoL) | Measured at participant's Day 1 of Cycle 1 (each cycle is 28 days) and at Day 1 of every Cycle thereafter for up to 2 years following the last participant last visit | Fatigue QoL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue Short Form (SF) 7a global fatigue score |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From the study start up to death or alive or lost to follow-up (up to approximately 4.8 years; data cut off date: 1 December 2021) | Full Analysis Set included all Group 2 participants randomized by IVRS/IWRS (exclude the open-label China safety cohort). | months | MEDIAN |
| PRIMARY | Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi) | From the study start up to death (up to approximately 4.8 years; data cut-off date: 1 December 2021) | Full Analysis Set included all Group 2 participants randomized by IVRS/IWRS (exclude the open-label China safety cohort). Open-Label China Safety Cohort included participants who received at least one dose of venetoclax. Data is reported for Group 2 and Open-label China Cohort. | percentage of participants | NUMBER |
| SECONDARY | Event-free Survival (EFS) | Measured up to 2 years after the last participant is randomized | |||
| SECONDARY | Global Health Status/Quality of Life (GHS/QoL) | Measured at participant's Day 1 of Cycle 1 (each cycle is 28 days) and at Day 1 of every Cycle thereafter for up to 2 years following the last subject last visit | |||
| SECONDARY | Percentage of Participants Achieving Composite Complete Remission (CR or CRi) | Up to 6 months after the first 225 participants are randomized | |||
| SECONDARY | Complete Remission or Complete Remission With Partial Hematologic Recovery Rate (CR+CRh) | Measured up to 2 years after the last participant is randomized | |||
| SECONDARY | Post Baseline Transfusion Independence Rate | Measured up to 2 years after the last participant is randomized | |||
| SECONDARY | Complete Remission (CR) Rate | Measured up to 2 years after the last participant is randomized | |||
| SECONDARY | Fatigue/Quality of Life (QoL) | Measured at participant's Day 1 of Cycle 1 (each cycle is 28 days) and at Day 1 of every Cycle thereafter for up to 2 years following the last participant last visit |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Group 2: Placebo + Azacitidine 75 mg/m^2 | 9.6 | 95% Confidence Interval 7.4 to 12.7 | months | |
| Overall Survival (OS) | Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2 | 14.7 | 95% Confidence Interval 12.1 to 18.7 | months | |
| Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi) | Group 2: Placebo + Azacitidine 75 mg/m^2 | CR | 17.9 | 95% Confidence Interval 12.1 to 25.2 | percentage of participants |
| Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi) | Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2 | CR | 38.8 | 95% Confidence Interval 33.1 to 44.7 | percentage of participants |
| Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi) | Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2 | CR | 60.0 | 95% Confidence Interval 26.2 to 87.8 | percentage of participants |
| Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi) | Group 2: Placebo + Azacitidine 75 mg/m^2 | CRi | 11.0 | 95% Confidence Interval 6.4 to 17.3 | percentage of participants |
| Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi) | Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2 | CRi | 28.0 | 95% Confidence Interval 22.8 to 33.6 | percentage of participants |
| Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi) | Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2 | CRi | 20.0 | 95% Confidence Interval 2.5 to 55.6 | percentage of participants |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: Placebo + Azacitidine 75 mg/m^2 | 1 | |
| Overall Study | STARTED | Group 1: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2 | 1 | |
| Overall Study | STARTED | Group 2: Placebo + Azacitidine 75 mg/m^2 | 145 | |
| Overall Study | STARTED | Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2 | 286 | |
| Overall Study | STARTED | Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2 | 10 | |
| Overall Study | COMPLETED | Group 1: Placebo + Azacitidine 75 mg/m^2 | 0 | |
| Overall Study | COMPLETED | Group 1: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2 | 0 | |
| Overall Study | COMPLETED | Group 2: Placebo + Azacitidine 75 mg/m^2 | 1 | |
| Overall Study | COMPLETED | Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2 | 48 | |
| Overall Study | COMPLETED | Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2 | 4 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events1,383
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2 | 24 | 144 | 30 |
| other | ANAEMIA | Blood and lymphatic system disorders | Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2 | 68 | 283 | 102 |
| other | ANAEMIA | Blood and lymphatic system disorders | Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2 | 6 | 10 | 11 |
| other | FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2 | 12 | 144 | 16 |
| other | FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2 | 33 | 283 | 44 |
| other | FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2 | 3 | 10 | 3 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2 | 20 | 144 | 46 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2 | 54 | 283 | 133 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2 | 10 | 10 | 20 |
| other | LYMPHADENOPATHY | Blood and lymphatic system disorders | Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2 | 2 | 144 | 2 |
1 to 10 of 1,383Source ClinicalTrials.gov
See all 1,383 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2 | 140 | 144 |
| Total, all-cause mortality | Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2 | 226 | 283 |
| Total, all-cause mortality | Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2 | 6 | 10 |
| Total, other adverse events | Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2 | 137 | 144 |
| Total, other adverse events | Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2 | 279 | 283 |
| Total, other adverse events | Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2 | 10 | 10 |
| Total, serious adverse events | Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2 | 111 | 144 |
| Total, serious adverse events | Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2 | 242 | 283 |
| Total, serious adverse events | Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2 | 7 | 10 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02993523
GET https://conductscience.org/api/trials/v1/NCT02993523/events?page=2