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Trial of Revumenib Plus FLA Chemotherapy for Children With Relapsed or Refractory NUP98-rearranged AML."

NCT07686107 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-07-22

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if Revumenib in combination with Fludarabine and Cytarabine can treat children with NUP98-rearranged relapsed or refractory Acute Myeloid Leukemia. The main question it aims to answer is:

What is the Best Overall Response Rate by morphologic response criteria after up to two cycles of revumenib in combination with fludarabine and cytarabine (FLA) chemotherapy?

Participants will receive up to two cycles of Revumenib in combination with fludarabine and cytarabine with intrathecal triple therapy. Participant may also receive a stem cell transplant followed by Revumenib monotherapy if it is necessary.

Up to 27 children and young adults will be enrolled.

Conditions

  • Leukemia, Myeloid, Acute

Interventions

DRUG

Revumenib

Patients under 40 kg, and those unable to swallow pills, must receive oral suspension (40 mg/mL): * \< 40 kg: 95 mg/m2 (max 160 mg/dose) orally twice daily * ≥ 40 kg (flat-dose): 160 mg orally twice daily * Round to the nearest markings on the syringe, within 10% of the calculated dose Patients ≥ 40 kg that are able to swallow pills: \- 160 mg orally twice daily

DRUG

Fludarabine

* 5 mg for patients with BSA 0.25-0.29 * 6.25 mg for patients with BSA 0.3-0.34 * 8.75 mg for patients with BSA 0.35-0.39 * 10 mg for patients with BSA 0.4-0.44 * 12.5 mg for patients with BSA 0.45-0.49 * 15 mg for patients with BSA 0.5-0.54 * 16.25 mg for patients with BSA 0.55-0.59 * 30 mg/m2/dose for patients with BSA \> 0.6

DRUG

Cytarabine (Ara-C)

* 300 mg for patients with BSA 0.25-0.29 * 420 mg for patients with BSA 0.3-0.34 * 560 mg for patients with BSA 0.35-0.39 * 680 mg for patients with BSA 0.4-0.44 * 820 mg for patients with BSA 0.45-0.49 * 960 mg for patients with BSA 0.5-0.54 * 1100 mg for patients with BSA 0.55-0.59 * 2000 mg/m2/dose for patients with BSA \> 0.6

DRUG

Methotrexate (IT)

Given intrathecally * 6 mg for patients \> 30 days - \< 1 year * 8 mg for patients \> 1 - \< 2 years * 10 mg for patients \> 2 - \< 3 years * 12 mg for patients \> 3 years

DRUG

Hydrocortisone (intrathecal)

Given intrathecally * 12 mg for patients \> 30 days - \< 1 year * 16 mg for patients \> 1 - \< 2 years * 20 mg for patients \> 2 - \< 3 years * 24 mg for patients \> 3 years

DRUG

Cytarabine (intrathecal)

Given intrathecally * 18 mg for patients \> 30 days - \< 1 year * 24 mg for patients \> 1 - \< 2 years * 30 mg for patients \> 2 - \< 3 years * 36 mg for patients \> 3 years

Sponsors & Collaborators

  • Therapeutic Advances in Childhood Leukemia Consortium

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2029-12-31
Completion
2030-12-31
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07686107 on ClinicalTrials.gov