Revumenib in Acute Myeloid Leukemia: NCT07498465 Clinical Landscape Report 2026

18 September 2026
9 min read

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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.

Data snapshot: 18 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.

Phase 1

Clinical phase

Withdrawn

Recruitment status

0

Planned enrollment

2028-11-12

Primary-completion proxy

Executive view

NCT07498465 evaluates Revumenib in Acute Myeloid Leukemia. The disclosed sponsor is The Children's Oncology Group Foundation, Inc., the design is Interventional, and the geographic footprint is Geography not reported. The first listed primary endpoint is Maximum tolerated dose (MTD), assessed over During cycles 1 and 2 (cycle length = 28 days).

The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.

PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.

How the MCP evidence stack was assembled

Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07498465 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Acute Myeloid Leukemia landscape. Drug & Asset MCP drug_fetch was queried for Revumenib, while Company & Deal Intelligence MCP organization_fetch was queried for The Children's Oncology Group Foundation, Inc..

This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.

Trial landscape table

TrialAsset / interventionPhase / statusSponsorGeographyPrimary endpointReadout proxy
NCT07498465RevumenibPhase 1 / WithdrawnThe Children's Oncology Group Foundation, Inc.Geography not reportedMaximum tolerated dose (MTD)
During cycles 1 and 2 (cycle length = 28 days)
2028-11-12
NCT07597941LisaftoclaxPhase 2/3 / Not yet recruitingSponsor not reportedGeography not reportedthe rate of Differentiation Syndrom
the induction regimen (21 days to 28 days)
2028-06-01
NCT07591649Fludarabine PhosphatePhase 1/2 / RecruitingUniversity of Minnesota Masonic Cancer CenterUnited StatesMaximum tolerated dose (MTD)
1 year
2030-03-01
NCT07588360BusulfanNot Applicable / RecruitingFujian Medical University Union HospitalChinaOverall Survival (OS)
3 years after transplantation
2028-10-20
NCT07583303Fludarabine PhosphatePhase 1 / Not yet recruitingCity of Hope National Medical CenterUnited StatesIncidence of dose-limiting toxicity
From the start of the infusion on day 0 through day 28
2027-04-16

The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.

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Protocol design and endpoint interpretation

NCT07498465 is a Phase 1, withdrawn study with 0 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.

The primary endpoint is “Maximum tolerated dose (MTD)” over “During cycles 1 and 2 (cycle length = 28 days).” The retrieved endpoint description is: Will use the Bayesian Optimal Interval (BOIN) design to estimate the MTD. The BOIN design with up to three pre-defined dose levels will estimate the MTD..

Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 0 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.

No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.

Indexed readouts in the surrounding landscape

5 recent result records were selected as contextual evidence for Acute Myeloid Leukemia. These records do not establish direct evidence for NCT07498465 unless the registration number matches.

Vyxeos for Induction of Newly Diagnosed Low- or Intermediate-risk AML Patients, Age 18-70. A Pilot Study

Phase 2; n=20; Response Rate for Low/Intermediate Risk Acute Myeloid Leukemia (AML) After Induction With Vyxeos With or Without Mylotarg. = 6 Participants ; Response Rate for Low/Intermediate Risk Acute Myeloid Leukemia (AML) After Induction With Vyxeos With or Without Mylotarg. = 13 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT05599360

Dordaviprone Maintenance After Allogeneic HCT for High‐Risk Acute Myeloid Leukemia and Myelodysplastic Neoplasm

Phase 1; n=20; AE(Grade ≥ 3) = 45.0 % Source: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/42359621/

A Phase II Study of CPX-351 in Younger Patients < 60 Years Old With Secondary Acute Myeloid Leukemia

Phase 2; n=21; CR = 8 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT04269213

Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.

Asset and sponsor context

Revumenib is indexed as Small molecule drug with menin biology and a global stage of Approved. The asset profile lists Syndax Pharmaceuticals, Inc. as an originator or developer.

The Children's Oncology Group Foundation, Inc. is indexed in United States with the website https://childrensoncologygroup.org. Children’s Oncology Group specializes in childhood and adolescent cancer research. The record lists 13 development-stage drug assets.

For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.

Development white space

  1. Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
  2. Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
  3. Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
  4. Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
  5. Sequencing white space. Clarify whether Revumenib is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.

White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.

Strategic implications and next readouts

For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.

For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.

Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.

Source trail and bottom line

Anchor trial: NCT07498465
Protocol source: https://clinicaltrials.gov/study/NCT07498465
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 18 September 2026.

Revumenib in Acute Myeloid Leukemia is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Maximum tolerated dose (MTD) and 2028-11-12 the leading decision points.

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