Acute Myeloid Leukemia Clinical Trial

A Study of SNDX-5613 in Combination With Chemotherapy in Participants With R/R Acute Leukemia

Summary

The purpose of this study is to determine the safety and tolerability of SNDX-5613 when given in combination with 2 different chemotherapy regimens in participants with relapsed/refractory leukemias harboring lysine methyltransferase 2A (KMT2A) or mNPM1.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Participants must have documented relapsed or refractory (R/R) AML, ALL, or acute leukemias of ambiguous lineage (ALAL) including MPAL and acute undifferentiated leukemia (AUL) harboring KMT2A rearrangement, KMT2A amplification, NPM1c, or NUP98r.
White blood count must be <25,000/microliter prior to the first dose of SNDX-5613. Participants may receive cytoreduction per protocol prior to beginning SNDX-5613.
Eastern Cooperative Oncology Group performance status score 0-2 (if aged ≥18 years); Karnofsky Performance Scale of ≥50 (if aged ≥16 years and <18 years); Lansky Performance Score of ≥50 (if aged <16 years).
Adequate liver, kidney, and cardiac function
Participant must be taking 1 of the following medications for antifungal prophylaxis: itraconazole, ketoconazole, posaconazole, or voriconazole.

A female of childbearing potential must agree to use a highly effective method of contraception or double barrier method from the time of enrollment through 120 days following the last study drug dose.

A male of childbearing potential must agree to use barrier contraception from the time of enrollment through 120 days following the last study drug dose.

Key Exclusion Criteria:

Any unresolved ≥Grade 2 reversible toxicity from previous anticancer therapy except alopecia or Grade 2 neuropathy
Graft-Versus-Host Disease (GVHD): Signs or symptoms of acute or chronic GVHD >Grade 0 within 4 weeks of enrollment. All transplant participants must have discontinued all systemic immunosuppressive therapy for at least 2 weeks and calcineurin inhibitors for at least 4 weeks prior to enrollment. Participants may be on physiological doses of steroids.
Concurrent malignancy in the previous 2 years, with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (for example, breast carcinoma, cervical cancer in situ, melanoma in situ) treated with potentially curative therapy. Concurrent malignancy must be in complete remission or no evidence of disease during this timeframe. For participants with therapy-related leukemia, primary disease must be in remission for 1-year following completion of therapy.
If the participant is known to be human immunodeficiency virus (HIV)-positive, the participant must have undetectable HIV viral load within the previous 6 months.
Hepatitis B
Hepatitis C

Cardiac Disease:

Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), life-threatening uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.
QTcF interval >450 milliseconds
Any gastrointestinal (GI) issue of the upper GI tract that might affect oral drug absorption or ingestion (for example, gastric bypass, gastroparesis).
Cirrhosis with a Child-Pugh score of B or C
Down Syndrome
Genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome.
Participation in another therapeutic interventional clinical study within 28 days of starting SNDX-5613.
Radiation Therapy: within 60 days from prior total body irradiation, craniospinal radiation and/or ≥50% radiation of the pelvis, or within 14 days from local palliative radiation therapy (small port).
Stem Cell Infusion or Donor Lymphocyte Infusion: within 60 days from hematopoietic stem cell transplantation and within 28 days from donor lymphocyte infusion without conditioning.
Biologics (for example, monoclonal antibody therapy, bispecific antibodies, and antibody-drug conjugates): within 28 days or 5 half-lives, whichever is longer, since the completion of therapy with a biologic agent.
Immunotherapy: within 42 days since tumor vaccines and checkpoint inhibitors, and within 21 days since receipt of chimeric antigen receptor therapy or other modified T-cell therapy.
Hematopoietic Growth Factors: within 7 days since the completion of therapy with short-acting hematopoietic growth factors and within 14 days with long-acting growth factors.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

54

Study ID:

NCT05326516

Recruitment Status:

Recruiting

Sponsor:

Syndax Pharmaceuticals

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There are 17 Locations for this study

See Locations Near You

Phoenix Children's Hospital
Phoenix Arizona, 85016, United States More Info
Felicia Frank
Contact
602-933-5004
[email protected]
University of California, San Francisco (UCSF) - Benioff Children's Hospital - Oakland
Oakland California, 94609, United States More Info
Emily Theobald
Contact
[email protected]
Children's Hospital Colorado
Aurora Colorado, 80045, United States More Info
Debra Schissel
Contact
[email protected]
Children's Healthcare of Atlanta
Atlanta Georgia, 30303, United States More Info
Amber Kaminski
Contact
[email protected]
Children's Healthcare of Atlanta
Atlanta Georgia, 30322, United States More Info
Amber Kaminski
Contact
[email protected]
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States More Info
Jaimie Pheneger
Contact
[email protected]
Children's Mercy Hospital
Kansas City Missouri, 64108, United States More Info
Emily Salata
Contact
816-302-6798
[email protected]
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Madeline Stowe
Contact
[email protected]
David H Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York New York, 10021, United States More Info
Daisy Rodriguez
Contact
[email protected]
Cincinnati Children's Hospital Medical Center
Cincinnati Ohio, 45229, United States More Info
Lori Backus
Contact
513-636-2047
[email protected]
Nationwide Children's Hospital
Columbus Ohio, 43205, United States More Info
Trittnee Robinson
Contact
[email protected]
Oregon Health & Science University (OHSU)
Portland Oregon, 97239, United States More Info
Emma Solanki
Contact
[email protected]
The Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19104, United States More Info
Tasleema Patel
Contact
[email protected]
St. Jude Children's Research Hospital, Inc
Memphis Tennessee, 38105, United States More Info
Emily Montgomery
Contact
[email protected]
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Allison Pike
Contact
[email protected]
Texas Children's Cancer and Hematology Center
Houston Texas, 77030, United States More Info
Kathy McCarthy
Contact
[email protected]
Seattle Children's Hospital
Seattle Washington, 98105, United States More Info
Megan Eyre
Contact
[email protected]
Jewish General Hospital
Québec Montreal, QC H3, Canada More Info
Adele Cascini
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

54

Study ID:

NCT05326516

Recruitment Status:

Recruiting

Sponsor:


Syndax Pharmaceuticals

How clear is this clinincal trial information?

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