Open trial map for KMT2A-rearranged and infant acute leukemia, September 2026 — what a clinician can actually enrol into today
also called open trials KMT2A · recruiting trials infant leukemia 2026 · menin inhibitor trial landscape
This is the list of clinical trials that are actually open right now for children with KMT2A-rearranged leukemia, marked clearly for which ones accept babies and children. It is the page to look at when a family asks what is available.
The same thing, for a scientist
A ClinicalTrials.gov sweep on 2026-09-18 across KMT2A-rearranged and infant acute leukemia and across all menin inhibitors. Every NCT identifier below was returned by the registry API in that sweep. The landscape has three distinct layers: frontline infant protocols (Interfant-21, NCT06317662, TINI 2), paediatric menin-inhibitor combination phase 1/2 studies, and a large adult phase 3 menin programme (over 3,000 planned patients across four trials) whose results will set practice long before any paediatric randomised data exist. The single most important structural gap: no trial anywhere randomises a menin inhibitor in frontline infant ALL.
PAEDIATRIC-ELIGIBLE AND OPEN NOW — the actionable list2 deeper
| NCT | What it is | Phase | n | Status | Notes |
|---|---|---|---|---|---|
| NCT05327894 | Interfant-21, blinatumomab, infants <1 y with KMT2A-r ALL or MPAL | 3 | 160 | RECRUITING | 124 sites. The randomised successor protocol. |
| NCT06317662 | Blinatumomab + chemo for newly diagnosed infants, KMT2A-r randomised to venetoclax | 2 | 153 | RECRUITING | NCI/COG, 115 sites. Opened June 2025. |
| NCT05848687 | TINI 2, total therapy for infants, includes blinatumomab and ziftomenib | 1/2 | 90 | RECRUITING | 24 sites. The only frontline infant protocol containing a menin inhibitor. |
| NCT04276870 | CART19 with an explicit cohort for infants with very high risk KMT2A B-ALL | 2 | 133 | RECRUITING | CHOP, single site. |
| NCT06376162 | Ziftomenib + fludarabine/cytarabine, children with R/R KMT2A-r, NUP98-r or NPM1-m | 1 | 20 | RECRUITING | PedAL, 20 sites. |
| NCT06177067 | Revumenib + azacitidine + venetoclax, paediatric/young adult R/R AML | 1 | 24 | RECRUITING | St. Jude, 10 sites. |
| NCT06397027 | Ziftomenib + venetoclax + azacitidine, paediatric R/R acute leukemia | 1 | 22 | RECRUITING | MD Anderson, single site. |
| NCT06448013 | Ziftomenib + venetoclax + gemtuzumab, paediatric AML | 1 | 22 | RECRUITING | MD Anderson, single site. |
| NCT06575296 | Revumenib as post-transplant maintenance, KMT2A-r or NPM1-m; childhood cohorts listed | 1 | 27 | RECRUITING | City of Hope, single site. |
| NCT04065399 | AUGMENT-101, revumenib in R/R leukemia; eligibility from age 30 days | 1/2 | 447 | RECRUITING | 57 sites. The registration trial, still open. |
| NCT04811560 | cAMeLot-1, bleximenib first-in-human in acute leukemia | 1/2 | 420 | RECRUITING | 102 sites. Confirm paediatric eligibility per protocol. |
| NCT04988555 | Horizen-1, enzomenib (DSP-5336) | 1/2 | 606 | RECRUITING | 104 sites. Confirm paediatric eligibility per protocol. |
| NCT07155226 | AZD3632, a new menin-pathway agent for KMT2Ar/NPM1m/HOX-high | 1/2 | 84 | RECRUITING | AstraZeneca, 30 sites. Includes ALL. |
All of the above were returned as RECRUITING by the registry on 2026-09-18 12.
Paediatric, open, but NOT YET RECRUITING or closed to accrual
- NCT05761171 — revumenib + chemotherapy for relapsed/refractory KMT2A-rearranged INFANT leukemia, COG, phase 2, n=78, 84 sites: ACTIVE, NOT RECRUITING. This is the most directly relevant paediatric menin trial ever run and it has stopped enrolling; its readout matters enormously.
- NCT07283640 — subcutaneous blinatumomab + revumenib in KMT2A-rearranged ALL, MD Anderson, phase 1b, n=20: NOT YET RECRUITING (planned start November 2026).
- NCT07636564 — SWOG, blinatumomab ± revumenib in KMT2A-translocated B-ALL/ALAL with persistent MRD, phase 2, n=90: NOT YET RECRUITING (planned October 2026).
- NCT07686107 — revumenib + FLA for children with R/R NUP98-rearranged AML, TACL, n=24: NOT YET RECRUITING.
Two paediatric trials were WITHDRAWN before enrolling anyone, which is a finding in itself:
- NCT07498465 — COG, revumenib as post-HSCT maintenance in paediatric ALL, AML and MPAL: WITHDRAWN, enrolment 0.
- NCT07052994 — MD Anderson, revumenib + cytarabine/daunorubicin/gemtuzumab in frontline and R/R paediatric acute leukemia: WITHDRAWN, enrolment 0.
The withdrawal of the COG paediatric post-transplant maintenance study is particularly consequential: post-transplant maintenance is where long-duration menin exposure would first be characterised in children, including the endocrine safety question that the adult labels raise. That study not opening leaves a real hole.
Adult phase 3 menin programme — over 3,000 planned patients
These will define practice, including for children, long before any paediatric randomised data exist:
- NCT07007312 — KOMET-017, ziftomenib + venetoclax/azacitidine (non-intensive) or 7+3 (intensive), untreated NPM1m or KMT2Ar AML. Phase 3, n=1300, recruiting, 115 sites.
- NCT07223814 — bleximenib or placebo + intensive induction/consolidation/maintenance, newly diagnosed KMT2Ar or NPM1m AML. Phase 3, n=875, recruiting, 82 sites (HOVON).
- NCT06652438 — revumenib + azacitidine/venetoclax versus placebo, untreated NPM1m or KMT2Ar AML unfit for intensive chemotherapy. Phase 3, n=448, recruiting, 201 sites (HOVON).
- NCT07211958 — revumenib + intensive chemotherapy, newly diagnosed NPM1-mutant AML. Phase 3, n=468, recruiting, 109 sites (Syndax).
Post-transplant maintenance is being pursued separately: NCT06440135 (ziftomenib, phase 1, recruiting), NCT07563010 (revumenib vs placebo, CIBMTR, phase 2, n=146, not yet recruiting), NCT07101497 and NCT07559695 (BN104 and real-world, Soochow).
The three things a clinician should take from this map
- A newly diagnosed infant has protocol options today — Interfant-21, NCT06317662 or TINI 2 — and TINI 2 is the only one of the three that includes a menin inhibitor.
- A relapsed child with KMT2A-rearranged disease has several menin-combination phase 1 options open, but the dedicated COG infant relapse study (NCT05761171) has closed to accrual, so availability now depends on reaching one of a small number of single-site studies.
- The evidence that will actually change practice is being generated in adults. Over 3,000 patients are enrolled in phase 3 menin trials, none of them infants. When those read out, menin inhibitors will become standard in adult AML on randomised evidence, and will be used in infants on extrapolation. That asymmetry is the defining structural feature of this field in 2026 and it is worth naming.
| snapshot date | 2026-09-18 |
|---|---|
| adult phase3 total planned | 3091 |
| structural gap | No trial randomises a menin inhibitor in frontline infant ALL. Over 3,000 adults are randomised; zero infants. |
pediatric eligible and recruiting — the numbers behind the chart
[
{
"nct": "NCT05327894",
"name": "Interfant-21",
"phase": "3",
"n": 160,
"population": "infants <1y KMT2A-r ALL/MPAL, frontline",
"sites": 124
},
{
"nct": "NCT06317662",
"name": "NCI/COG infant blinatumomab ± venetoclax",
"phase": "2",
"n": 153,
"population": "newly diagnosed infant ALL",
"sites": 115
},
{
"nct": "NCT05848687",
"name": "TINI 2",
"phase": "1/2",
"n": 90,
"population": "infant ALL total therapy, includes ziftomenib",
"sites": 24
},
{
"nct": "NCT04276870",
"name": "CART19 orphan indications",
"phase": "2",
"n": 133,
"population": "includes infants with VHR KMT2A B-ALL",
"sites": 1
},
{
"nct": "NCT06376162",
"name": "PedAL ziftomenib + FLA",
"phase": "1",
"n": 20,
"population": "children R/R KMT2A-r / NUP98-r / NPM1-m",
"sites": 20
},
{
"nct": "NCT06177067",
"name": "St. Jude revumenib + aza + ven",
"phase": "1",
"n": 24,
"population": "paediatric R/R AML",
"sites": 10
},
{
"nct": "NCT06397027",
"name": "MDACC ziftomenib + ven + aza",
"phase": "1",
"n": 22,
"population": "paediatric R/R acute leukemia",
"sites": 1
},
{
"nct": "NCT06448013",
"name": "MDACC ziftomenib + ven + gemtuzumab",
"phase": "1",
"n": 22,
"population": "paediatric AML",
"sites": 1
},
{
"nct": "NCT06575296",
"name": "City of Hope revumenib post-HSCT maintenance",
"phase": "1",
"n": 27,
"population": "KMT2A-r or NPM1-m, childhood cohorts listed",
"sites": 1
},
{
"nct": "NCT04065399",
"name": "AUGMENT-101",
"phase": "1/2",
"n": 447,
"population": "R/R leukemia, eligibility from age 30 days",
"sites": 57
}
]pediatric closed or pending
[
{
"nct": "NCT05761171",
"status": "ACTIVE_NOT_RECRUITING",
"note": "COG revumenib + chemo for R/R KMT2A-r INFANT leukemia, n=78 — the most directly relevant paediatric menin trial"
},
{
"nct": "NCT07283640",
"status": "NOT_YET_RECRUITING",
"note": "SC blinatumomab + revumenib, KMT2A-r ALL"
},
{
"nct": "NCT07636564",
"status": "NOT_YET_RECRUITING",
"note": "SWOG blinatumomab ± revumenib for persistent MRD"
},
{
"nct": "NCT07686107",
"status": "NOT_YET_RECRUITING",
"note": "TACL revumenib + FLA, paediatric NUP98-r AML"
},
{
"nct": "NCT07498465",
"status": "WITHDRAWN",
"note": "COG revumenib post-HSCT maintenance in children — enrolment 0"
},
{
"nct": "NCT07052994",
"status": "WITHDRAWN",
"note": "MDACC revumenib + 7+3 + gemtuzumab paediatric — enrolment 0"
}
]adult phase3 menin — the numbers behind the chart
[
{
"nct": "NCT07007312",
"n": 1300,
"name": "KOMET-017 ziftomenib"
},
{
"nct": "NCT07223814",
"n": 875,
"name": "HOVON bleximenib intensive"
},
{
"nct": "NCT06652438",
"n": 448,
"name": "HOVON revumenib + aza/ven"
},
{
"nct": "NCT07211958",
"n": 468,
"name": "Syndax revumenib + IC, NPM1m"
}
]- This page decays. Registry snapshots are wrong within weeks; anyone using it for a real patient must re-run the search.
- Registry status is not site activation: a trial listed as recruiting at 115 sites may be open at very few, and for an infant who cannot travel that distinction is everything.
- Trial availability drives treatment choice more than evidence does. A child gets the menin inhibitor whose trial happens to be open at their centre, which quietly makes the comparative-effectiveness question unanswerable.
- The adult-first structure of the evidence means that the toxicities most specific to infants — growth, neurocognition, endocrine development, vaccine responses — will be discovered after the drugs are already in routine paediatric use, not before.
- Why were both paediatric post-transplant and frontline revumenib studies (NCT07498465, NCT07052994) withdrawn with zero enrolment? Understanding whether this was funding, competing accrual or a safety concern is directly decision-relevant.
- What did NCT05761171 (COG revumenib in R/R infant KMT2A-r leukemia, n=78) show? It has closed to accrual and its readout is the best paediatric menin dataset that will exist for years.
- Should the field accept that menin inhibitors will enter infant practice on adult extrapolation? Over 3,000 adults are randomised and no infants are. If the answer is no, the time to insist on an infant randomisation is while Interfant-21 is still enrolling.
- Are the adult first-in-human menin studies (bleximenib cAMeLot-1, enzomenib Horizen-1, AZD3632) actually enrolling children? Their registry entries are ambiguous and the protocols should be checked, because they represent significant unused paediatric capacity.
- E1strong confidence 4 of 5: Replicated in peer-reviewed work by more than one group.trial_registry
A ClinicalTrials.gov search for recruiting and not-yet-recruiting trials in KMT2A-rearranged acute leukemia or infant acute lymphoblastic leukemia on 2026-09-18 returned 23 studies, including Interfant-21 (NCT05327894, recruiting, phase 3, n=160, 124 sites), NCT06317662 (recruiting, phase 2, n=153, 115 sites), TINI 2 (NCT05848687, recruiting, phase 1/2, n=90), NCT04276870 (recruiting, phase 2, n=133, with an infant very-high-risk KMT2A B-ALL cohort) and NCT05761171 (COG, active not recruiting, phase 2, n=78).
ClinicalTrials.gov API v2 search, condition 'KMT2A rearranged acute leukemia OR infant acute lymphoblastic leukemia', status RECRUITING or NOT_YET_RECRUITING, retrieved 2026-09-18 · US National Library of Medicine, ClinicalTrials.gov · ClinicalTrials.gov 2026What this evidence cannot show
Registry records are sponsor-maintained and update irregularly; a study listed as recruiting may have closed, and site-level activation varies within a multicentre trial. Condition-based search misses trials that do not name the genotype. THIS SNAPSHOT DECAYS: it is accurate as of 2026-09-18 and should be re-run before any clinical use. Paediatric eligibility in the adult-led first-in-human studies (NCT04811560, NCT04988555, NCT07155226) must be confirmed against the protocol, not inferred from the registry summary.
Evidence that argues against this (1)
- A dated registry snapshot degrades fastest in exactly the way that matters to the family reading it. Recruiting status is sponsor-maintained and updated at sponsor discretion, so a study listed as recruiting on 2026-09-18 may have closed, paused or filled without the record changing. This entry is a pointer to search again, not a list that can be relied on later. ClinicalTrials.gov 2025
- E2strong confidence 4 of 5: Replicated in peer-reviewed work by more than one group.trial_registry
A ClinicalTrials.gov search across revumenib, ziftomenib, bleximenib, enzomenib, icovamenib and 'menin inhibitor' on 2026-09-18 returned 65 studies, including four recruiting phase 3 trials with a combined planned enrolment of 3,091 adults (NCT07007312 n=1300, NCT07223814 n=875, NCT06652438 n=448, NCT07211958 n=468), multiple recruiting paediatric phase 1 combinations (NCT06376162, NCT06177067, NCT06397027, NCT06448013), post-transplant maintenance studies (NCT06575296, NCT06440135, NCT07563010), and two withdrawn paediatric studies with zero enrolment (NCT07498465, NCT07052994).
ClinicalTrials.gov API v2 search, intervention 'revumenib OR ziftomenib OR bleximenib OR enzomenib OR icovamenib OR menin inhibitor', retrieved 2026-09-18 · US National Library of Medicine, ClinicalTrials.gov · ClinicalTrials.gov 2026What this evidence cannot show
The search returned 65 total records of which 60 were retrieved; five were not paginated through, so this list is near-complete rather than exhaustive. Planned enrolment figures are targets, not accrual. Withdrawn status means no participants were enrolled, but the registry does not always state why. Some non-leukemia menin-inhibitor trials (type 2 diabetes, solid tumours) are excluded from this node as out of scope.
Evidence that argues against this (1)
- Registry records state status without reason, which this project has already been caught by: COVALENT-101 is listed TERMINATED with no stated cause, and the termination is equally consistent with futility, toxicity or portfolio reprioritisation. A trial map built from status fields therefore conveys availability and nothing about why an option disappeared - the question a family asks first. ClinicalTrials.gov 2025
- ← refutesThe counter-argument: the menin field is an adult field, and the infant studies were withdrawn
Counter-evidence (whyStopped fields read 2026-09-18): NCT07052994 is MD Anderson with whyStopped 'PI requested' and NCT07498465 is the Children's Oncology Group with whyStopped 'Other - Protocol moved to Withdrawn'. Two of the three withdrawals are academic, not commercial, so the three-withdrawal pattern over-attributes to adult commercial gravity.
- ← depends onThe counter-argument: the menin field is an adult field, and the infant studies were withdrawn
withdrawn paediatric studies recorded in the 2026 trial map
which trials a child could actually enter right now
- related to →Interfant-21 (NCT05327894) — the randomised test of blinatumomab in infant KMT2A-rearranged ALL, open now
listed as recruiting, phase 3, n=160, 124 sites
listed as recruiting, eligibility from 30 days of age
five post-transplant menin maintenance studies registered; the paediatric one was withdrawn with zero enrolment
over 3,000 adults randomised to frontline menin inhibitors and zero infants