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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]

Must not have

Diagnosis of acute promyelocytic leukemia

Hematopoietic stem cell transplantation (HSCT) within 60 days of screening or active graft versus-host-disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 and 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am 18 or older with BPDCN that has come back or didn't respond to treatment, excluding hydroxyurea.

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I am 18 or older with AML that has come back or didn’t respond to treatment, excluding hydroxyurea.

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I am over 18 and have MDS with more than 10% myeloblasts in my bone marrow.

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I have been diagnosed with AML, MDS, or BPDCN according to WHO criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with acute promyelocytic leukemia.

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I had a stem cell transplant less than 2 months ago or have ongoing graft versus host disease.

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My cancer has spread to my brain or spinal cord, and I've had the necessary tests to confirm.

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I have HIV, hepatitis B, or hepatitis C.

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I do not have severe heart or lung conditions that are not under control.

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I do not have any active advanced cancer except for certain skin cancers or cancers that are contained within the place they started.

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I am not pregnant or breastfeeding.

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I haven't taken strong CYP3A inducers in the last 7 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 and 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 and 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose

Secondary study objectives

Complete Response Rate

Duration of remission

Overall Survival

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~2200

Azacitidine

2012

Completed Phase 3