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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05326516
Recruitment Status : Recruiting
First Posted : April 13, 2022
Last Update Posted : April 24, 2023
Sponsor:
Information provided by (Responsible Party):
Syndax Pharmaceuticals

Study Description
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Brief 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), mNPM1, or NUP98.

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Leukemias Acute Lymphoblastic Leukemia Acute Lymphocytic Leukemia Mixed Phenotype Acute Leukemia Acute Myeloid Leukemia Drug: SNDX-5613 Drug: Chemotherapy Regimen 1 Drug: Chemotherapy Regimen 2 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will use a Bayesian optimal interval (BOIN) design to evaluate the doses and determine the maximum tolerated dose.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AUGMENT-102: A Phase 1, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability and Preliminary Anti-Leukemic Activity of SNDX-5613 in Combination With Chemotherapy in Patients With Relapsed/Refractory Leukemias Harboring Alterations in KMT2A/MLL, Nucleophosmin 1 (NPM1), and Nucleoporin 98 (NUP98) Genes
Actual Study Start Date : March 9, 2022
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: SNDX-5613 and Chemotherapy Regimen 1
Participants with acute lymphoblastic leukemia/mixed phenotype acute leukemia (ALL/MPAL) will receive SNDX-5613 every 12 hours in combination with 2 treatment cycles of Chemotherapy Regimen 1.
 Drug: SNDX-5613
Participants will receive SNDX-5613 until meeting criteria for discontinuation.

Drug: Chemotherapy Regimen 1
Participants will receive 2 treatment cycles of chemotherapy. During Cycle 1, participants will receive prednisone, vincristine, pegaspargase, and daunorubicin. During Cycle 2, participants will receive etoposide and cyclophosphamide.
Experimental: SNDX-5613 and Chemotherapy Regimen 2
Participants with ALL/MPAL or acute myeloid leukemia (AML) will receive SNDX-5613 every 12 hours in combination with 2 treatment cycles of Chemotherapy Regimen 2.
 Drug: SNDX-5613
Participants will receive SNDX-5613 until meeting criteria for discontinuation.

Drug: Chemotherapy Regimen 2
Participants will receive 2 treatment cycles of chemotherapy. During Cycles 1 and 2, participants will receive fludarabine and cytarabine.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Dose Limiting Toxicities From SNDX-5613 [ Time Frame: Day 1 through up to 30 days after last dose of study intervention ]
  2. Number of Participants With Treatment-emergent Adverse Events [ Time Frame: Day 1 through up to 30 days after last dose of study intervention ]

Secondary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) Of SNDX-5613 [ Time Frame: Predose through up to 6 hours post dose ]
  2. Area Under The Plasma Concentration Versus Time Curve From Time 0 To t (AUC0-t) Of SNDX-5613 [ Time Frame: Predose through up to 6 hours post dose ]
  3. Area Under The Concentration Versus Time Curve From Time 0 To 24 Hours (AUC0-24) Of SNDX-5613 [ Time Frame: Predose through up to 6 hours post dose ]

Eligibility Criteria
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Ages Eligible for Study:   30 Days and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 NUP98.
  • 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 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: within 60 days from hematopoietic stem cell transplantation and within 28 days from donor lymphocyte infusion without conditioning.
  • Biologics (for example, monoclonal antibody therapy, antibody-drug conjugates): within 28 days or 5 half-lives, whichever is shorter, 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05326516


Contacts
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Contact: Syndax Pharmaceuticals 781-419-1400 clinicaltrials@syndax.com

Locations
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United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Felicia Frank    602-933-5004    ffrank@phoenixchildrens.org   
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Debra Schissel       debra.schissel@childrenscolorado.org   
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Amber Jenkins    816-302-6891    anjenkins@cmh.edu   
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Madeline Stowe       mstowe@wustl.edu   
United States, New York
David H Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Daisy Rodriguez       rodrigd@mskcc.org   
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Lori Backus    513-636-2047    lori.backus@cchmc.org   
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Tasleema Patel       patelt6@chop.edu   
United States, Tennessee
St. Jude Children's Research Hospital, Inc Recruiting
Memphis, Tennessee, United States, 38105
Contact: Emily Montgomery       Emily.montgomery@stjude.org   
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Allison Pike       apike@mdanderson.org   
Texas Children's Cancer and Hematology Center Recruiting
Houston, Texas, United States, 77030
Contact: Kathy McCarthy       ksmccart@texaschildrens.org   
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Megan Eyre       megan.eyre@seattlechildrens.org   
Sponsors and Collaborators
Syndax Pharmaceuticals
Investigators
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Study Director: Nicole McNeer, MD, PhD Syndax Pharmaceuticals
More Information
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Responsible Party: Syndax Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05326516    
Other Study ID Numbers: SNDX-5613-0702
First Posted: April 13, 2022    Key Record Dates
Last Update Posted: April 24, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Syndax Pharmaceuticals:
SNDX-5613
AUGMENT
KMT2A/MLL Gene Rearrangement
Nucleophosmin 1 Mutation
 NPM1
Nucleoporin 98
NUP98
Menin
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases