Trial · NCT05761171
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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. |
| Other | PK of calaspargase pegol and the associated toxicities for patients with R/R KMT2A-R ALL | Up to 5 years from enrollment | Analyses will be conducted for lymphoid and myeloid blocks separately and then combined and will be restricted to patients who receive calaspargase-pegol. These analyses will be exploratory and descriptive. |
| Other | Anti-cancer therapies received before and after administration of revumenib by patients with R/R KMT2A-R ALL | Up to 5 years from enrollment | The types of anti-cancer therapies received by patients before or after administration of revumenib will be described. The association between the anti-cancer therapies patients received prior to enrollment and response may also be assessed. The association between the anti-cancer therapies received after revumenib and EFS or OS may be assessed. These analyses will be exploratory and descriptive. |
| Other | MRD negative remission rate in patients with R/R infant KMT2A-R ALL among patients < 6 months at enrollment | Up to 3 cycles of combination therapy (each cycle is a minimum of 29 days) | The overall MRD negative remission rate after treatment with revumenib in combination with chemotherapy will be described among patients \< 6 months at enrollment. The MRD negative remission rate will be described by dose level. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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