Trial · NCT04655391
Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation
NCT04655391, Phase 1, Withdrawn, City of Hope Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation. Trials, record NCT04655391. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04655391
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation
- NCT number
- NCT04655391
- Status
- Withdrawn
- Phases
- Phase 1
- Enrollment
- 0 participants, actual
- Lead sponsor
- City of Hope Medical Center
- Conditions
- Recurrent Acute Myeloid Leukemia
- Interventions
- Bosutinib Monohydrate, Decitabine, Enasidenib Mesylate, Gilteritinib Fumarate, Glasdegib Maleate, Ivosidenib, Venetoclax
- First posted
- 2020-12-07
- Last updated
- 2022-06-09
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ability to obtain a molecular diagnosis (Molecular Diagnosis Segment) | From study enrollment to return of Molecular Diagnosis Report, assessed up to 30 days | Outcome will be dichotomized based on return in =\< 10 calendar days (Yes/No). Assessed by the proportion of successful participants. |
| Primary | Ability to make a treatment arm assignment by the Treatment Assignment Committee (TAC) (Molecular Diagnosis Segment) | From enrollment to treatment arm assignment by the TAC, assessed up to 30 days | Outcome will be dichotomized based on return in =\< 14 calendar days (Yes/No). Assessed by the proportion of participants who receive treatment assignment from TAC. |
| Primary | Incidence of adverse events (Treatment Segment) | Up to 30 days | Toxicity will be graded according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Safety will be based on the assessment of dose limiting toxicity during cycle 1 and cycle 2. Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome. |
| Secondary | Proportion of patients with successful sequencing (Molecular Diagnosis Segment) | Up to 30 days | Successful sequencing is defined as passing quality control, and will be determined by City of Hope pathology among those with less than 20% blasts in the marrow aspirate. |
| Secondary | Proportion of patients with successful treatment arm registration (Molecular Diagnosis Segment) | Up to 30 days | Successful placement defined as the enrollment of a participant into one of the treatment arms. |
| Secondary | Incidence of adverse events (Molecular Diagnosis Segment) | Up to 30 days | Toxicity will be graded according to the NCI-CTCAE version 5.0. Safety will be based on the assessment of unacceptable toxicity during glasdegib monotherapy. Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome. |
| Secondary | Overall response (Treatment Segment) | Up to the date of the first of 2 successive bone marrows showing said response, assessed up to 30 days | Response will be based on Dohner et al., 2017 criteria. Response dates recorded will be the date of the first of 2 successive bone marrows showing said response. For this trial, will assess the complete remission rate calculated as the percent of evaluable patients that have confirmed complete response (CR) or incomplete blood count recovery (CRi). 95% Clopper Pearson binomial confidence interval will be calculated. Response rates will also be explored based on number/type of prior therapy(ies). |
| Secondary | Duration of remission (Treatment Segment) | Time from the first of two consecutive bone marrow aspirates showing CR or CRi until such time as the bone marrow or peripheral blood mononuclear cells shows signs of relapse, assessed up to 30 days | |
| Other | Change in leukemia stem cell (LSC) burden (Treatment Segment) | Baseline up to post-treatment (2 cycles) (each cycle = 28 days) | Measured by limiting dilution and engraftment into non-obese diabetic severe combined immunodeficiency gamma severely immunocompromised mice. Graphical statistics will be used. To assess the association between the LSC reduction and the response to the treatment, the median change from baseline to post-treatment (2 cycles) in engraftment levels of secondary mice recipients (n=12 mice/patient, 6 females and 6 males) will be compared by two-sample t test between response and non-response patient groups as LSC donors, across all treatment arms. The effect of treatment on the target genes will be assessed for each arm by linear mixed models (pre- versus multiple post-treatment time points) as well. |
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 |
|---|---|---|---|---|---|
| P30CA033572 | Cancer Center Support Grant | CARPTEN, JOHN D. | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | 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/NCT04655391
GET https://conductscience.org/api/trials/v1/NCT04655391/registered