Trial · NCT03471260
Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies
NCT03471260, Phase 1, Phase 2, Recruiting, M.D. Anderson Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies. Trials, record NCT03471260. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03471260
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies
- NCT number
- NCT03471260
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 96 participants, estimated
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Acute Myeloid Leukemia, Hematopoietic and Lymphoid System Neoplasm, Myelodysplastic Syndrome, Myeloproliferative Neoplasm, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
- Interventions
- Azacitidine, Ivosidenib, Venetoclax
- First posted
- 2018-03-20
- Last updated
- 2026-09-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall response rate (ORR) | Up to 3 years | Defined as complete response (CR), CR with incomplete blood count recovery (CRi), morphologic leukemia-free state (MLFS), and partial response (PR) based on revised International Working Group (IWG) response criteria. Analysis will be performed for enrolled subjects. |
| Primary | Incidence of adverse events | Up to 3 years | Will be collected using leukemia adverse event guidelines. |
| Primary | Dose-limiting toxicity | Up to 56 days | Defined as any grade 3 or 4, clinically significant non-hematologic adverse event or abnormal laboratory value. |
| Secondary | Response to therapy | Up to 3 years | Will be calculated. |
| Secondary | Duration of response | From the date of initial response to first documented disease progression/relapse or death, assessed up to 3 years | Will be calculated. |
| Secondary | Event-free survival | From treatment initiation to date of documented treatment failure, relapse, or death from any cause, assessed up to 3 years | Will be calculated. |
| Secondary | Overall survival | Up to 3 years | Will be calculated. |
| Other | Plasma concentrations and pharmacokinetic parameter | Up to 3 years | Will be tabulated for each subject, visit, and dose level, and summary statistics will be computed for each sampling time and each parameter. |
| Other | Peripheral blood and bone marrow aspirate samples | Up to 3 years | Biomarker assays may include, but are not limited to, BH3 profiling and characterization of BCL-2 and related proteins, IDH1 mutant status, serum R-2HG analysis, and assessment of the depth of response and monitoring of disease recurrence by assessment of minimal residual disease in the bone marrow. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
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/NCT03471260
GET https://conductscience.org/api/trials/v1/NCT03471260/registered