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SL-401 + Azacitidine/Venetoclax for AML and MDS
Study Summary
This trial is studying how well SL-401, azacitidine, and venetoclax work in treating patients with acute myeloid leukemia, blastic plasmacytoid dendritic cell neoplasm, or high-risk myelodysplastic syndrome.
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?
Media Library
- I am 18 or older with BPDCN that has come back or didn't respond to treatment, excluding hydroxyurea.I am 18 or older with AML that has come back or didn’t respond to treatment, excluding hydroxyurea.I am 18 or older with AML and have not had intensive chemotherapy due to health reasons.I have been diagnosed with acute promyelocytic leukemia.I haven't had cancer treatment in the last 14 days, except for intrathecal chemotherapy or hydroxyurea.I had a stem cell transplant less than 2 months ago or have ongoing graft versus host disease.I have HIV, hepatitis B, or hepatitis C.My cancer has spread to my brain or spinal cord, and I've had the necessary tests to confirm.I do not have severe heart or lung conditions that are not under control.I do not have any active advanced cancer except for certain skin cancers or cancers that are contained within the place they started.I am not pregnant or breastfeeding.I can take pills and do not have serious digestive issues affecting absorption.I am over 18 and have MDS with more than 10% myeloblasts in my bone marrow.My blood tests show my organs are functioning well.I agree to use contraception during and for 2 months after the study.I haven't taken strong CYP3A inducers in the last 7 days.I have been diagnosed with AML, MDS, or BPDCN according to WHO criteria.My infection is under control and I am receiving treatment for it.I last took venetoclax more than 2 months ago, if at all.My cancer cells tested positive for CD123/IL3RA within the last 3 months.
- Group 1: SL-401+ Azacitidine
- Group 2: SL-401+ Azacitidine + Venetoclax
- 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
What safety precautions have been taken to ensure SL-401 is secure for patients?
"The safety of SL-401 is assessed at a 1 due to the limited amount of data pertaining to its efficacy and safety as this is only Phase 1."
Is participation in this experiment still accessible to individuals?
"Clinicaltrials.gov attests to this clinical trial's active recruitment status, which was initiated on June 26th 2017 and revised most recently on June 13th 2022."
Could you please enumerate any prior experiments involving SL-401?
"Presently, 345 experiments with SL-401 are underway; 54 of these trials have reached phase three. The majority of the studies for this drug are centered in Edmonton, Alberta and there are 11,210 sites across the world running related tests."
What indications is SL-401 typically used to treat?
"SL-401 is a popular choice for induction chemotherapy, and it has proven effective in managing refractory anemias, leukemia, myelocytic disorders, acute diseases, and multilineage dysplasia."
How many participants are being recruited for this experiment?
"This clinical trial necessitates 72 patients who meet the criteria of admission. Patients can take part in this investigation from Dana Farber Cancer Institute and MD Anderson Cancer Center, both located within state borders of Massachusetts and Texas respectively."
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