Trial · NCT05854966
CPI-613 Given With Metformin in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
NCT05854966, Phase 2, Withdrawn, Wake Forest University Health Sciences
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. CPI-613 Given With Metformin in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML). Trials, record NCT05854966. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05854966
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CPI-613 Given With Metformin in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
- NCT number
- NCT05854966
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
- Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory, Granulocytic Sarcoma
- Interventions
- CPI 613, Metformin, Blood draws, Bone marrow biopsy
- First posted
- 2023-05-11
- Last updated
- 2024-09-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants to Receive at Least One Cycle of Maintenance Therapy - Feasibility | After the completion of cycle 1 of maintenance therapy (maintenance cycle is 21 days) | Feasibility is defined as the ability to deliver at least 1 cycle of maintenance therapy in 50% or more of patients who complete induction therapy. |
| Secondary | Response Rate - Efficacy (Acute Myeloid Leukemia European LeukemiaNet 2022) | After the completion of cycle 2 (each cycle is 14 days), then every three months up to 12 months | Efficacy will be assessed in the first 9 evaluable participants using a Simon's two-stage design to examine efficacy in terms of response where response is defined as: * Complete remission (CR) (Bone marrow blasts, 5%; absence of circulating blasts; absence of extramedullary disease; ANC ≤ 1.0 × 109/L (1,000/μL); plate) or * Complete remission with incomplete count recovery (CRi) (All CR criteria except for residual neutropenia \< 1.0 × 109/L (1,000/μL) or thrombocytopenia \< 100 × 109/L (100,000/μL) or * Morphologically leukemia free state (MLFS) (Bone marrow blasts \< 5%; absence of circulating blasts; absence of extramedullary disease; no hematologic recovery required). |
| Secondary | Overall Survival | Every 3 months after last dose of study treatment, up to 2 years | Overall survival is calculated in days from date of study treatment initiation to date of death due to any cause. Patients last known to be alive are censored at date of last contact. |
| Secondary | Number of Reported Adverse Events - Safety | Up to 30 days after last dose of study treatment | Safety will be evaluated by describing the nature and frequency of adverse events as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
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.
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 |
|---|---|---|---|---|---|
| P30CA012197 | Cancer Center Support Grant | MESA, RUBEN A. | WAKE FOREST UNIVERSITY HEALTH SCIENCES | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
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/NCT05854966
GET https://conductscience.org/api/trials/v1/NCT05854966/registered