Palbociclib, All-Trans Retinoic Acid, and Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia
NCT07926607, Phase 1, Phase 2, Not yet recruiting, Second Affiliated Hospital of Nanchang University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Palbociclib, All-Trans Retinoic Acid, and Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia | ClinicalTrials.gov |
| NCT number | NCT07926607 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1, Phase 2 | ClinicalTrials.gov |
| Enrollment | 55 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Second Affiliated Hospital of Nanchang University | ClinicalTrials.gov |
| Conditions | Acute Myeloblastic Leukemia | ClinicalTrials.gov |
| Interventions | Palbociclib, All-trans retinoic acid, Venetoclax | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of Dose-Limiting Toxicities (DLTs) During Phase Ib | During the first 28-day treatment cycle (Days 1-28) | The proportion of participants experiencing dose-limiting toxicities (DLTs) during the first 28-day treatment cycle in Phase Ib. DLTs will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0, and include Grade 4 or higher hematologic toxicity lasting more than 7 days with bone marrow hypoplasia or Grade 3 or higher nonhematologic toxicity that does not resolve with optimal supportive care. | ClinicalTrials.gov |
| Primary | Overall Response Rate (ORR) During Phase II | At the end of each 28-day treatment cycle, until disease progression or treatment discontinuation | The proportion of participants in Phase II who achieve complete remission (CR), complete remission with incomplete hematologic recovery (CRi), or partial remission (PR). Treatment response will be assessed by bone marrow examination according to the response criteria specified in the study protocol. | ClinicalTrials.gov |
| Secondary | Maximum Tolerated Dose (MTD) During Phase Ib | During the first 28-day treatment cycle (Days 1-28) | The highest evaluated dose level of palbociclib in combination with all-trans retinoic acid and venetoclax that is considered tolerable based on dose-limiting toxicities observed during the Phase Ib 3+3 dose-escalation stage. | ClinicalTrials.gov |
| Secondary | Recommended Phase II Dose (RP2D) | From initiation of study treatment through completion of the Phase Ib dose-escalation stage, assessed up to 6 months. | The recommended Phase II dose of palbociclib in combination with all-trans retinoic acid and venetoclax, determined based on the dose-limiting toxicity findings and overall safety and tolerability during Phase Ib. | ClinicalTrials.gov |
| Secondary | Incidence and Severity of Adverse Events (AEs) | From the first dose of study treatment through 30 days after the last dose, assessed up to 12 months. | The number and percentage of participants experiencing adverse events (AEs) and serious adverse events (SAEs), including their severity and relationship to study treatment. Adverse events will be graded according to NCI CTCAE version 5.0. | ClinicalTrials.gov |
| Secondary | Complete Remission (CR) and Complete Remission With Incomplete Hematologic Recovery (CRi) Rate | At the end of each 28-day treatment cycle, until disease progression or treatment discontinuation | The proportion of participants achieving CR or CRi. CR is defined as bone marrow blasts below 5%, absence of peripheral blood blasts and extramedullary disease, absolute neutrophil count above 1.0 × 10\^9/L, and platelet count above 100 × 10\^9/L. CRi meets the bone marrow criteria for CR but with incomplete neutrophil or platelet recovery. | ClinicalTrials.gov |
| Secondary | Measurable Residual Disease (MRD) Negativity Rate | At the end of each 28-day treatment cycle in participants achieving CR or CRi | The proportion of participants achieving MRD negativity among those with CR or CRi. MRD will be assessed by multiparameter flow cytometry, with MRD negativity defined as a level below 0.1%. | ClinicalTrials.gov |
| Secondary | Event-Free Survival (EFS) | From the date of study enrollment to the first occurrence of disease progression, relapse, or death from any cause, whichever occurs first, assessed up to 24 months. | Time from study enrollment to the first occurrence of disease progression, relapse, or death from any cause. Participants without an event will be censored at the date of their last disease assessment. | ClinicalTrials.gov |
| Secondary | Overall Survival (OS) | From the date of study enrollment to death from any cause, assessed up to 24 months. | Time from study enrollment to death from any cause. Participants who are alive at the time of analysis will be censored at the date they were last known to be alive. | ClinicalTrials.gov |
| Secondary | Duration of Response (DOR) | From the date of first documented CR or CRi to disease relapse or death from any cause, whichever occurs first, assessed up to 24 months. | Time from the first documented CR or CRi to disease relapse or death from any cause, whichever occurs first, among participants achieving CR or CRi. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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 | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)