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

Status
Closed
Cancer Type
Leukemia
Trial Phase
Phase I
Eligibility
30 Days and older, Male and Female
Study Type
Treatment
NCT ID
NCT05326516
Protocol IDs
SNDX-5613-0702 (primary)
NCI-2022-04065
Study Sponsor
Syndax Pharmaceuticals

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 acute leukemias harboring KMT2A rearrangement, KMT2A amplification,
NPM1c, or NUP98r.

Eligibility

  1. 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.
  2. 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.
  3. 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).
  4. Adequate liver, kidney, and cardiac function
  5. Participant must be taking 1 of the following medications for antifungal prophylaxis: itraconazole, ketoconazole, posaconazole, or voriconazole.
  6. 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.
  7. 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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.