Expanded Access Program for SNDX-5613

Sponsor

Syndax Pharmaceuticals (Industry)

Overall Status

Available

CT.gov ID

NCT05918913

Collaborator

(none)

Study Details

Study Description

Brief Summary

This expanded access program will provide an investigational treatment option in a controlled clinical setting for patients who are not otherwise eligible to participate in a clinical study and have no approved treatment options.

Condition or Disease	Intervention/Treatment	Phase
Relapsed/Refractory Acute Leukemia	Drug: SNDX-5613

Study Design

Study Type:

Expanded Access

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Days and Older

Sexes Eligible for Study:

All

Key Inclusion Criteria:

Male or female participant aged ≥30 days.
Not eligible for participation in an ongoing clinical study.
Participant or participant's health care proxy is able and willing to provide written informed consent and able to follow study instructions.
Diagnosed with relapsed/refractory acute leukemia harboring a mixed lineage leukemia rearrangement, 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 method of contraception.

For participants currently being treated with SNDX-5613 in a Syndax-sponsored clinical study 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 to be 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 patients 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.