← Back to Search

Small Molecule

Revumenib + Chemotherapy for Relapsed/Refractory Leukemia

Phase 2

Recruiting

Led By Kelly E Faulk

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years from enrollment

Awards & highlights

Study Summary

This trial tests a new drug's safety and best dose when combined with chemo to treat leukemia in children that has come back or doesn't respond to treatment.

Who is the study for?

This trial is for infants and young children aged 1 month to under 6 years, diagnosed with KMT2A-rearranged leukemia that's either relapsed or unresponsive to treatment. They should have a white blood cell count below 50,000/uL and be mostly recovered from previous treatments' side effects. Kids over a year old need to be at least half as active as usual (Lansky Scale >= 50%). Those with severe brain involvement by leukemia must improve before joining.Check my eligibility

What is being tested?

The study tests Revumenib combined with chemotherapy in kids who have specific gene changes in their leukemia cells. The goal is to see if this mix works better than standard treatments alone. It includes drugs like vincristine, prednisone, asparaginase, fludarabine, and cytarabine which stop cancer cells from growing or kill them.See study design

What are the potential side effects?

Revumenib might cause stomach issues, fatigue or liver problems since it targets certain cell changes. Chemotherapy can lead to hair loss, nausea/vomiting, increased infection risk due to low blood counts and potential damage to organs like the heart or kidneys.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years from enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years from enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years from enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of dose-limiting toxicities (DLTs) for lymphoid directed chemotherapy block (Safety Phase)

Incidence of dose-limiting toxicities (DLTs) for myeloid directed chemotherapy block (Safety Phase)

Minimal residual disease (MRD) negative remission rate in patients with relapsed/refractory (R/R) infant KMT2A-R ALL (Expansion Phase)

Secondary outcome measures

Characterization of tolerability of SNDX-5613 given as monotherapy in patients with R/R infant KMT2A-R ALL

Estimation of 18-month event-free survival (EFS) rate in patients with R/R infant KMT2A-R ALL

Estimation of 18-month overall survival (OS) rate in patients with R/R infant KMT2A-R ALL

+1 more

Other outcome measures

Anti-cancer therapies received before and after administration of SNDX-5613 by patients with R/R KMT2A-R ALL

Changes in KMT2A-R transcriptional program

Changes to menin displacement

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Regimen B (revumenib, FLA)Experimental Treatment10 Interventions

COMBINATION CYCLES 1-2: Patients receive revumenib PO or via NG, ND, NJ, or G-tube every 12 hours continuously, "FLA" IV on days 1-5, MTX IT, hydrocortisone IT, and cytarabine IT on day 0 and optionally on days 8, 15, and 22 of each cycle. Cycles repeat every 28 days for 2 cycles. MONOTHERAPY: Patients receive revumenib PO or via NG, ND, NJ, or G-tube every 12 hours continuously. Treatment repeats every 28 days for up to 12 cycles on study in the absence of disease progression or unacceptable toxicity. Patients may also receive MTX IT, hydrocortisone IT, and cytarabine IT on days 0, 8, 15 and 22 as clinically indicated. All patients also undergo ECHO or MUGA, collection of blood and CSF samples, lumbar puncture, and bone marrow aspiration throughout the trial.

Group II: Regimen A (revumenib, 3-drug re-induction, FLA)Experimental Treatment14 Interventions

See Detailed Description.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Lumbar Puncture

2016

Completed Phase 3

~510

Biospecimen Collection

2004

Completed Phase 2

~1700

Prednisolone

2005

Completed Phase 4

~2720

Cytarabine

2016

Completed Phase 3

~3310

Echocardiography

2013

Completed Phase 4

~11670

Fludarabine Phosphate

1997

Completed Phase 3

~2390

Hydrocortisone Sodium Succinate

2008

Completed Phase 3

~70

Methotrexate

2013

Completed Phase 4

~3800

Prednisone

2014

Completed Phase 4

~2370

Vincristine Sulfate

2005

Completed Phase 3

~10150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor

454 Previous Clinical Trials

237,862 Total Patients Enrolled

Kelly E FaulkPrincipal InvestigatorChildren's Oncology Group

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies available for participants in this clinical test?

"The clinical research hosted on clinicialtrials.gov conveys that this trial is presently accepting participants, the initial posting of which occurred in November 20th 2023 with an update taking place four weeks later."

Answered by AI

Is eligibility for this research restricted to persons aged 45 or younger?

"For this particular trial, individuals aged between 1 month and 6 years old are eligible to apply. Moreover, there is a plethora of clinical trials dedicated for those below 18 (606) or above 65 (1986)."

Answered by AI

What is the upper limit for participants in this investigation?

"This clinical trial necessitates the participation of 78 patients who meet its pre-established inclusion criteria. Patients have two locations from which to choose: Golisano Children's Hospital of Southwest Florida in Fort Myers, FL or Cincinnati Children’s Hospital Medical Center in Ohio."

Answered by AI

What positive developments is it hoped that this trial will yield?

"The main metric of success for this clinical trial, which will be monitored during Cycles 1 and 2 for Regimen A and Cycle 1 for Regimen B, is the rate of Minimal Residual Disease (MRD) negative remission. Secondary objectives include estimating 18-month overall survival rate utilizing Kaplan-Meier method; assessing if 90% or more patients achieve desired pharmacokinetics in expansion phase; and characterizing tolerability of SNDX-5613 given as monotherapy by measuring Grade 3+ adverse events."

Answered by AI

What adverse effects could be expected from utilizing revumenib, 3-drug re-induction, and FLA (Regimen A)?

"Our team at Power has assigned a safety score of 2 to the Regimen A intervention (revumenib, 3-drug re-induction, FLA), which is currently in Phase 2 trials. While there are some preliminary data supporting its security profile, no clinical evidence exists yet that corroborates efficacy."

Answered by AI

Am I qualified to participate in this research project?

"This medical trial is accepting participants aged 1 month to 6 years old that have been diagnosed with acute leukemia. Thus far, 78 patients have enrolled in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of SNDX-5613 in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia

2024. "A Study of SNDX-5613 in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05761171.