Trial · NCT05564650
Navitoclax in Relapsed or Refractory High-Risk Myelodysplastic Syndrome
NCT05564650, Phase 1, Completed, Thomas Jefferson University
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Navitoclax in Relapsed or Refractory High-Risk Myelodysplastic Syndrome. Trials, record NCT05564650. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05564650
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Navitoclax in Relapsed or Refractory High-Risk Myelodysplastic Syndrome
- NCT number
- NCT05564650
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 6 participants, actual
- Lead sponsor
- Thomas Jefferson University
- Conditions
- Myelodysplastic Syndrome, Recurrent Myelodysplastic Syndrome, Refractory Myelodysplastic Syndrome
- Interventions
- Navitoclax, Venetoclax, Decitabine, Bone Marrow Biopsy, Biospecimen Collection, Laboratory Biomarker Analysis, Quality-of-Life Assessment
- First posted
- 2022-10-03
- Last updated
- 2026-05-19
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximally Tolerated Dose (MTD) of Navitoclax in Combination with Venetoclax and Decitabine (Phase I) | Within 30 days of the first dose of study treatment | The Bayesian optimal interval (BOIN) design will be employed to find the MTD. The BOIN design is implemented in a simple way. It is more flexible and possesses superior operating characteristics that are comparable to those of the more complex model based designs. |
| Primary | Complete Response (CR) Rate (Phase II) | Up to cycle 4, an average of 4 months | A 90% confidence interval will be computed for the CR rate by cycle 4. |
| Secondary | Number of Dose-Limiting Toxicities (Phase I) | Within 30 days of the first dose of study treatment | Number of dose-limiting toxicities (Phase I) |
| Secondary | Marrow Complete Response Rate (mCR) (Phase II) | Up to 2 years from enrollment of the last patient | Defined as per International Working Group (IWG) criteria. |
| Secondary | Hematologic Improvement (HI) rate (Phase II) | Up to 2 years from enrollment of the last patient | Defined as per IWG criteria. |
| Secondary | Leukemia Free Survival (LFS) (Phase II) | Up to 2 years from enrollment of the last patient | LFS defined as the time from the date of randomization to the date of diagnosis of AML or death from any cause, whichever came first. |
| Secondary | Overall survival (OS) (Phase II) | Up to 2 years from enrollment of the last patient | Will be estimated using the Kaplan-Meier method, and the median OS along with its corresponding 95% confidence interval will be reported. |
| Secondary | Change in quality of life (QOL) (Phase II) | At baseline | Will be assessed by European Organization for Research and Treatment of Cancer (EORTC Quality of Life Questionnaire \[EORTC QLQ-C30\]. |
| Secondary | Change in quality of life (QOL) (Phase II) | At 4 months | Will be assessed by European Organization for Research and Treatment of Cancer (EORTC Quality of Life Questionnaire \[EORTC QLQ-C30\] |
| Secondary | Change in quality of life (QOL) (Phase II) | Up to 2 years from enrollment of the last patient | Will be assessed by European Organization for Research and Treatment of Cancer (EORTC Quality of Life Questionnaire \[EORTC QLQ-C30\] |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT05564650
GET https://conductscience.org/api/trials/v1/NCT05564650/registered