Trial · NCT05455294
Combination Navitoclax, Venetoclax and Decitabine for Advanced Myeloid Neoplasms
NCT05455294, Phase 1, Active not recruiting, Jacqueline Garcia, MD
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Combination Navitoclax, Venetoclax and Decitabine for Advanced Myeloid Neoplasms. Trials, record NCT05455294. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05455294
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Navitoclax, Venetoclax and Decitabine for Advanced Myeloid Neoplasms
- NCT number
- NCT05455294
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 16 participants, actual
- Lead sponsor
- Jacqueline Garcia, MD
- Conditions
- Myeloid Malignancy, Myelodysplastic Syndromes, Myelofibrosis, Acute Myeloid Leukemia, Myeloproliferative Neoplasm
- Interventions
- Navitoclax, Venetoclax, Decitabine
- First posted
- 2022-07-13
- Last updated
- 2026-01-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended Phase 2 Dose (RP2D) | The observation period for RP2D evaluation was the first 28 days (cycle 1) of treatment. | The RP2D is the minimally safe and biologically effective dose. The minimally safe dose is the highest dose level at which \<2 of 6 participants experience a dose limiting toxicity (DLT). See subsequent primary outcome for the DLT definition. With respect to safety, the RP2D will also consider laboratory evidence of platelet recovery. Evaluation of efficacy will be done in real time prioritizing full complete response (see subsequent secondary outcome for the objective response criteria) when possible for AML/MDS/MDS-MPN and transfusion independence/blast reduction/TSS improvement/splenic reduction for myelofibrosis. |
| Primary | Dose Limiting Toxicity (DLT) | The observation period for DLT evaluation was the first 28 days (cycle 1) of treatment. | DLT is defined by hematologic or non-hematologic adverse event (AE) per protocol (section 5.4); A treatment-related death is a DLT; AEs are graded based on NCI CTCAE v5.0 and must be considered unrelated to the underlying disease or co-morbidity to be a DLT. |
| Secondary | Objective Response Rate (ORR) | Bone marrow evaluation for disease response is performed end of C1, C2, every 2 cycles until CR/CRi and then every 3 cycles. Each cycle is 28 days. Time frame is indefinite as based on maximum treatment duration which is not fixed. | Response criteria follows consensus guidelines set forth by international working groups for MF, MDS (MDS: CR, marrow CR, PR, HI), MDS/MPN overlap syndromes, and AML. ORR, evaluated by disease type, is defined as the proportion of participants achieving objective response per protocol (section 11.1) on treatment: * AP/BP-MF: CR, PR, Clinical Improvement * MDS: CR, marrow CR, PR, HI * CMML: CR, PR, marrow CR * s-AML: CR, CRi, CRp |
| Secondary | Median Progression-Free Survival (PFS) | Bone marrow evaluation for disease response is performed days 22-28 of C1, end of C2, every 2 cycles (cycle end) until CR/CRi and then every 3 cycles. Off treatment, disease is assessed every 4 months up to 2 years. | Progression-free survival based on the Kaplan-Meier method is defined as the time from study treatment to evidence of progression (for MDS per IWG 2006 criteria; for AML per ELN 2017 criteria; for MF per IWG criteria, defined per protocol section 11.1) or at death due to any cause including underlying disease. Participants alive without disease progression are censored at date of last follow up. |
| Secondary | Overall Survival (OS) | Survival is assessed in long-term follow-up every 4 months up to 2 years. | OS based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive. |
| Other | Navitoclax Target Dose Rate | While on study treatment for up 1 year | The navitoclax target dose rate is the proportion of participants without navitoclax dose modifications on treatment per protocol. |
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.
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/NCT05455294
GET https://conductscience.org/api/trials/v1/NCT05455294/registered