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SNDX-5613 + Chemotherapy for Leukemia
Study Summary
This trial is testing a new drug, SNDX-5613, to see if it is safe and effective when given with chemotherapy to people with leukemia that has come back or does not respond to treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My leukemia has returned or didn't respond to treatment and has specific genetic changes.I don't have lasting side effects from cancer treatment, except for hair loss or mild nerve issues.I have a stomach or upper GI issue that could affect how I absorb pills.I haven't had serious heart issues like a heart attack or stroke in the last 6 months.I haven't had any cancer except for some skin cancers or early-stage cancers treated successfully in the last 2 years.I haven't had severe GVHD symptoms or been on strong immune-suppressing drugs recently.I am currently taking an antifungal medication like itraconazole.I have a genetic condition known to cause bone marrow failure.I haven't had biologic therapy for at least 28 days or 5 half-lives, whichever is longer.I have Down Syndrome.My liver, kidneys, and heart are working well.My liver disease is severe, with a Child-Pugh score of B or C.I have not had major radiation therapy in the last 2 months or small area radiation in the last 2 weeks.My white blood cell count is below 25,000 before starting SNDX-5613 treatment.I received immunotherapy less than 42 days ago for vaccines and checkpoint inhibitors, or less than 21 days for CAR-T or modified T-cell therapy.I had a stem cell transplant within the last 60 days or a donor lymphocyte infusion within the last 28 days without prior conditioning.I can take care of myself and perform daily activities.I have Hepatitis B.I haven't used short-acting blood cell boosters in the last 7 days or long-acting ones in the last 14 days.I agree to use effective birth control during and up to 120 days after the study.I have Hepatitis C.I am a man who can father a child and will use condoms during the study and for 120 days after.
- Group 1: SNDX-5613 and Chemotherapy Regimen 2
- Group 2: SNDX-5613 and Chemotherapy Regimen 1
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants are engaged in this clinical experimentation?
"Affirmative. According to the information found on clinicaltrials.gov, recruitment for this medical trial is ongoing since its initial posting date of March 9th 2022 and last updated on July 18th 2022. Currently, 54 participants are being sought from 2 participating facilities."
Has the FDA sanctioned SNDX-5613 for use?
"Our team at Power scored SNDX-5613 with a 1 on the safety scale as this is an early Phase 1 trial, so there are limited published data to demonstrate its efficacy and security."
Are there still vacancies available for volunteers in this clinical trial?
"Clinicaltrials.gov states that the study is actively searching for participants, with its initial posting being made on March 9th 2022 and a subsequent update occurring on July 18th 2022."
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