Trial · NCT05761171
A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia
NCT05761171, Phase 2, Active not recruiting, Children's Oncology Group
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia. Trials, record NCT05761171. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05761171
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia
- NCT number
- NCT05761171
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 78 participants, estimated
- Lead sponsor
- Children's Oncology Group
- Conditions
Recurrent Acute Leukemia of Ambiguous Lineage, Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia Due to Lineage Switch From Acute Leukemia of Ambiguous Lineage, Recurrent Acute Myeloid Leukemia Due to Lineage Switch From B Acute Lymphoblastic Leukemia, KMT2A-Rearranged, Recurrent Acute Myeloid Leukemia Due to Lineage Switch From Mixed Phenotype Acute Leukemia, Recurrent Mixed Phenotype Acute Leukemia, Refractory Acute Leukemia of Ambiguous Lineage, Refractory Acute Lymphoblastic Leukemia, Refractory Acute Myeloid Leukemia Due to Lineage Switch From Acute Leukemia of Ambiguous Lineage, Refractory Acute Myeloid Leukemia Due to Lineage Switch From B Acute Lymphoblastic Leukemia, KMT2A-Rearranged, Refractory Acute Myeloid Leukemia Due to Lineage Switch From Mixed Phenotype Acute Leukemia, Refractory Mixed Phenotype Acute Leukemia
- Interventions
Biospecimen Collection, Bone Marrow Aspiration, Calaspargase Pegol, Cytarabine, Echocardiography Test, Electrocardiogram, Fludarabine Phosphate, Hydrocortisone Sodium Succinate, Lumbar Puncture, Methotrexate, Multigated Acquisition Scan, Prednisolone, Prednisone, Revumenib, Vincristine Sulfate
- First posted
- 2023-03-09
- Last updated
- 2026-08-25
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of dose-limiting toxicities (DLTs) for lymphoid directed chemotherapy block (Safety Phase) | At the end of Cycle 1 of Regimen A (each cycle is a minimum of 29 days) | Regimen A Cycle 1 will be used for determination of recommended phase 2 dose (RP2D)-lymphoid (L) directed chemotherapy block. A patient will be considered as being evaluable for DLT if: (1) the patient receives at least 44 doses of the first planned 28 days (56 doses) of revumenib for cycle 1 (for patients with delayed revumenib shipment, will count 28 days from the start of revumenib); or (2) the patient experiences a DLT after the start of revumenib in that cycle. |
| Primary | Incidence of dose-limiting toxicities (DLTs) for myeloid directed chemotherapy block (Safety Phase) | At the end of Cycle 1 of Regimen B and at the end of Cycle 2 of Regimen A (each cycle is a minimum of 29 days) | Regimen B Cycle 1 and Regimen A Cycle 2 will be used for determination of RP2D-myeloid (M) directed chemotherapy block. For each cycle mentioned above, a patient will be considered as being evaluable for DLT if: (1) the patient receives at least 44 doses of the first planned 28 days (56 doses) of revumenib for the cycle (for patients with delayed revumenib shipment, will count 28 days from the start of revumenib); or (2) the patient experiences a DLT after the start of revumenib in that cycle. For determination of RP2D-M, patients in Regimen A who have experienced a DLT in Cycle 1 or who have been evaluated as having Early Progressive Disease in Cycle 1 are excluded. |
| Primary | Minimal residual disease (MRD) negative remission rate in patients with relapsed/refractory (R/R) infant KMT2A-R ALL among patients >= 6 months at enrollment (Expansion Phase) | Up to 3 cycles of combination therapy (each cycle is a minimum of 29 days) | A patient with R/R infant KMT2A-R ALL will be included in the primary analysis of MRD negative remission rate if the patient is enrolled at RP2D-L and RP2D-M (in the safety phase or the expansion phase) and receives at least one dose of protocol treatment. This response rate will be estimated using the approach of Jung and Kim. The corresponding 95% confidence interval will be calculated using the approach of Koyama and Chen. |
| Secondary | Proportion of patients achieving desired SNDX-5613 pharmacokinetics (PK) | Up to 2 years from enrollment | Analyses will be conducted for lymphoid and myeloid blocks separately and then combined. Will monitor if there is evidence that the proportion of patients achieving desired PK is considerably lower than 90% using the Pocock stopping boundaries. |
| Secondary | Estimation of 18-month event-free survival (EFS) rate in patients with R/R infant KMT2A-R ALL | Time from date of enrollment to date of treatment failure, relapse, second or secondary malignancy (SMN), or death due to any cause, whichever occurs first, assessed up to 18 months | Will be estimated using the Kaplan-Meier method. Cumulative incidence rates of each EFS event type (relapse, SMN and death) will be estimated and be presented with cumulative incidence curves. |
| Secondary | Estimation of 18-month overall survival (OS) rate in patients with R/R infant KMT2A-R ALL | Time from date of enrollment to death due to any cause, assessed up to 18 months | Will be estimated using the Kaplan-Meier method. |
| Secondary | Characterization of tolerability of revumenib given as monotherapy in patients with R/R infant KMT2A-R ALL | Up to 2 years from enrollment | Grade 3+ adverse events (AEs) will be summarized among patients receiving monotherapy, by cycles, and the proportion of patients having grade 3+ AEs will be estimated. |
| Other | Changes in KMT2A-R transcriptional program | Up to 5 years from enrollment | Ribonucleic acid (RNA) will be isolated from cryopreserved leukemic cell suspensions and exploratory analysis of RNA sequencing (Seq) will be performed. Principal component analysis and gene set enrichments will be used to compare overall transcriptional signatures, and specifically the reported KMT2A-R dependent gene sets, comparing paired pre-treatment and post-treatment samples. Correlations between changes in RNA-Seq and patient's clinical response to SNDX-5613 as well as pharmacokinetic parameters and menin displacement will be described. |
| Other | Changes to menin displacement | Up to 5 years from enrollment | Pre-treatment and post-treatment paired samples will be tested for menin occupancy by CUT\&RUN, and changes to informative histone modifications/protein complexes evaluated by CUT\&Tag. The degree of reduction in menin binding to specific target genes will be correlated with clinical response and pharmacokinetic parameters, as well as biologic transcriptional changes. |
| Other | MRD negative remission rates in patients with R/R non-infant KMT2A-R ALL | Up to 3 cycles of combination therapy (each cycle is a minimum of 29 days) | MRD negative remission rates will be summarized. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 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.
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 |
|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
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/NCT05761171
GET https://conductscience.org/api/trials/v1/NCT05761171/registered