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Chemotherapy
SL-401 + Azacitidine/Venetoclax for AML and MDS
Phase 1
Recruiting
Led By Andrew Lane, MD, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years with relapsed or refractory BPDCN (hydroxyurea is not considered a prior treatment regimen) [Cohort C]
Age >= 18 years with relapsed or refractory AML (hydroxyurea is not considered a prior treatment regimen) [Cohort B]
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 and 2 years
Awards & highlights
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.
Who is the study for?
Adults with confirmed diagnoses of AML, high-risk MDS, or BPDCN who have adequate organ function and can consent to the study. They must not be pregnant, breastfeeding, have active CNS involvement by their disease, known HIV/Hepatitis B/C infections, other advanced malignancies needing treatment or gastrointestinal conditions affecting medication absorption.Check my eligibility
What is being tested?
The trial is testing SL-401 in combination with Azacitidine alone or with Venetoclax for treating AML, high-risk MDS, and BPDCN. It aims to evaluate the effectiveness and safety of these drug combinations in different patient cohorts based on their specific conditions.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, nausea and vomiting. There could also be liver function abnormalities and potential heart issues like irregular heartbeat.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older with BPDCN that has come back or didn't respond to treatment, excluding hydroxyurea.
Select...
I am 18 or older with AML that has come back or didn’t respond to treatment, excluding hydroxyurea.
Select...
I am over 18 and have MDS with more than 10% myeloblasts in my bone marrow.
Select...
I have been diagnosed with AML, MDS, or BPDCN according to WHO criteria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 and 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 and 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose
Secondary outcome measures
Complete Response Rate
Duration of remission
Overall Survival
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: SL-401+ Azacitidine + VenetoclaxExperimental Treatment3 Interventions
SL-401 will be administered every 4 weeks, on a 28 day cycle; SL-401 will be given intravenously; Azacitidine will be administered every 4 weeks, on a 28 day cycle; Azacitidine will be given intravenously or subcutaneously; Venetoclax will be administered for 21 days on a 28 day cycle; Venetoclax will be taken orally
Group II: SL-401+ AzacitidineExperimental Treatment2 Interventions
SL-401 will be administered every 4 weeks, on a 28 day cycle; SL-401 will be given intravenously; Azacitidine will be administered every 4 weeks, on a 28 day cycle; Azacitidine will be given intravenously or subcutaneously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Azacitidine
2012
Completed Phase 3
~1440
SL-401
2014
Completed Phase 2
~220
Find a Location
Who is running the clinical trial?
Stemline Therapeutics, Inc.OTHER
18 Previous Clinical Trials
1,813 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,876 Total Patients Enrolled
Andrew Lane, MD, PhDPrincipal Investigator - Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: SL-401+ Azacitidine
- Group 2: SL-401+ Azacitidine + Venetoclax
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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