Expanded Access Program for SNDX-5613 in Patients With Relapsed/Refractory Acute Leukemias With Genetic Alterations Associated With HOXA Overexpression REVUMENIB EXPANDED ACCESS PROGRAM

What's the purpose of this trial?

This expanded access program will provide an investigational treatment option in a controlled clinical setting for participants who are not otherwise eligible to participate in other Syndax-sponsored clinical studies and have no approved treatment options.

This trial is currently open and accepting patients.


You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Key Inclusion Criteria:

* Male or female participant aged ≥30 days.
* Not eligible for participation in an ongoing clinical study and have no approved treatment options.
* Participant or participant's health care proxy is able and willing to provide written informed consent and able to follow study instructions.
* Relapsed or refractory (R/R) acute leukemia, as defined by standardized criteria, after standard of care therapy, including but not limited to 1 or 2 cycles of intensive chemotherapy, or venetoclax combinations:

1. R/R leukemia is defined by the presence of ≥5% blasts in the bone marrow and/or persistence or reappearance of peripheral blasts.
2. Participants with persistent leukemia after initial therapy or recurrence of leukemia at any time after achieving a response during or after the course of treatment (including allogeneic hematopoietic stem cell transplant \[HSCT\]) are eligible.
3. Participants with isolated extra medullary disease are allowed if extramedullary disease was confirmed with biopsy.
4. Participants previously treated on a revumenib clinical trial who are entering the expanded access program for post-transplant maintenance because they are not eligible to receive revumenib on trial or because the trial is closed are not required to meet the relapse/refractory status. Participants who underwent HSCT and are eligible to resume treatment with revumenib will be dosed with the last revumenib tolerated dose prior to transplant.
* Acute leukemia harboring a lysine (K) methyltransferase 2A gene rearrangement (KMT2Ar), nucleoporin 98 rearrangement, nucleophosmin 1 mutation (or mutated) mutation or any other genetic alteration with overexpression of HOXA genes predicted to potentially respond to menin inhibitors.
* Adequate liver, renal, and cardiac function.
* Adequate methods of contraception are required during childbearing age from the time of enrollment through 120 days following the last study drug dose. Barrier contraception in males and double barrier in females or other highly effective methods of contraception.

For participants currently being treated with revumenib in a Syndax-sponsored clinical study or Syndax investigator-sponsored trial, the following criteria must be met:

* In the opinion of the Investigator, participant demonstrated acceptable benefit from and tolerability of the study drug.
* Participant is considered compliant with study drug and procedures.
* Participant does not meet any criteria for study drug discontinuation.
* Investigator and participant agree to continue study drug treatment.

Key Exclusion Criteria:

* Evidence of uncontrolled infection.
* Pregnant or nursing women.
* Cardiac or gastrointestinal disease.
* Graft-Versus-Host Disease (GVHD): Signs or symptoms of acute or chronic GVHD \>Grade 1 within 4 weeks of enrollment. All transplant participants must have been off all systemic immunosuppressive therapy for at least 1 week prior to enrollment and calcineurin inhibitors for at least 1 week, with the exception of steroids.
* History of or any concurrent condition, therapy, laboratory abnormality, or allergy to excipients that, in the Investigator's opinion, either may interfere with the participant's participation or results in the conclusion that it is not in the best interest of the participant to participate.

Additional Trial Information

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

Phoenix Children's Hospital

Phoenix, AZ

Open and Accepting

California

City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting

Stanford Univ Med Ctr. / Lucile Packard Children's Hosp

Palo Alto, CA

Open and Accepting

Colorado

The Children's Hospital of Colorado

Aurora, CO

Open and Accepting

University of Colorado Cancer Center Anschutz Cancer Pavilion

Aurora, CO

Open and Accepting

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Open and Accepting

Children's Healthcare of Atlanta Egleston Hospital

Atlanta, GA

Open and Accepting

Illinois

University of Chicago Medicine Comprehensive Cancer Center

Chicago, IL

Open and Accepting

Iowa

Massachusetts

Dana-Farber Cancer Institute

Boston, MA

Open and Accepting

Missouri

Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Open and Accepting

Children's Mercy Hospitals and Clinics

Kansas City, MO

Open and Accepting

New Jersey

Memorial Sloan Kettering Basking Ridge

Basking Ridge, NJ

Open and Accepting

Memorial Sloan Kettering Monmouth

Middletown, NJ

Open and Accepting

Memorial Sloan Kettering Bergen

Montvale, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Memorial Sloan Kettering Commack

Commack, NY

Open and Accepting

Memorial Sloan Kettering Nassau

Uniondale, NY

Open and Accepting

Memorial Sloan Kettering Westchester

West Harrison, NY

Open and Accepting

Ohio

Cincinnati Children's Hospital Medical Center

Cincinnati, OH

Open and Accepting

Oregon

Oregon Health and Science University OHSU Knight Cancer Institute

Portland, OR

Open and Accepting

Pennsylvania

Children's Hospital of Philadelphia

Philadelphia, PA

Open and Accepting

Tennessee

St. Jude Children's Research Center

Memphis, TN

Open and Accepting

Texas

Texas Children's Cancer Center

Houston, TX

Open and Accepting

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting

Utah

Huntsman Cancer Institute University of Utah

Salt Lake City, UT

Open and Accepting

Washington

Seattle Children's Hospital

Seattle, WA

Open and Accepting
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