Trial · NCT03613532
Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN
NCT03613532, Phase 1, Active not recruiting, Jacqueline Garcia, MD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN. Trials, record NCT03613532. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03613532
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN
- NCT number
- NCT03613532
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 102 participants, actual
- Lead sponsor
- Jacqueline Garcia, MD
- Conditions
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), MDS/Myeloproliferative Neoplasm-unclassifiable (MDS/MPN-unclassifiable), Hematopoietic Stem Cell Transplant
- Interventions
- Venetoclax, Fludarabine, Busulfan, Venetoclax, Azacitidine, Decitabine/cedazuridine
- First posted
- 2018-08-03
- Last updated
- 2026-05-20
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MTD of Venetoclax with Busulfan and Fludarabine | 37 Days | Determine safe dose and schedule of venetoclax |
| Primary | MTD of Venetoclax with Azacitidine as Maintenance Therapy | 28 Days from Maintenance Therapy Start | Determine safe dose and schedule of venetoclax |
| Primary | MTD of Venetoclax with Decitabine/cedazuridine as Maintenance Therapy | 28 Days from Maintenance Therapy Start | Determine safe dose and schedule of venetoclax |
| Secondary | Overall Survival | 12 Months | Time from treatment start until death |
| Secondary | Progression Free Survival | 12 Months | Time from treatment start until relapse |
| Secondary | Overall Response Rate | At day 100, 6 months and 12 months | IWG response criteria |
| Secondary | Remission Duration Rate | from start of the treatment until disease relapse (assessed at day 100, 6 months and 12 months) | Duration of remission from treatment start until relapse |
| Secondary | Rate of Disease Relapse | 12 Months | Frequency of disease recurrence on trial |
| Secondary | Rate of Non-Relapse Mortality | 12 Months | Frequency of death that is not due to disease recurrence on trial |
| Secondary | Donor granulocyte chimerism percentage | 28 Days Post-Transplant | Percentage of donor blood cells |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
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.
Papers4
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/NCT03613532
GET https://conductscience.org/api/trials/v1/NCT03613532/registered