RecruitingPhase 1NCT03113643

SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Phase 1 Study of SL-401 in Combination With Azacitidine and Venetoclax in Relapsed/Refractory Acute Myeloid Leukemia (AML) and in Treatment-Naive Subjects With AML Not Eligible for Standard Induction and in Subjects With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) or SL-401 in Combination With Azacitidine in Subjects With High-Risk Myelodysplastic Syndrome (MDS)


Sponsor

Dana-Farber Cancer Institute

Enrollment

72 participants

Start Date

Jun 26, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

This research study is studying a drug as a possible treatment for diagnosis of AML, BPDCN and high-risk MDS. The interventions involved in this study are: * SL-401 * Azacitidine * Venetoclax


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called SL-401 combined with azacitidine (with or without venetoclax) for patients with certain blood cancers — including acute myeloid leukemia (AML), high-risk myelodysplastic syndrome (MDS), or a rare cancer called BPDCN — that have not responded to or have come back after treatment. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with AML, high-risk MDS, or BPDCN (confirmed by biopsy) - Your cancer cells show a protein called CD123 (confirmed by a lab test within the past 3 months) - For AML: your cancer came back or didn't respond to treatment, OR you are newly diagnosed but not able to handle intensive chemotherapy - For MDS: more than 10% of your bone marrow cells are abnormal blast cells - For BPDCN: your cancer came back or didn't respond to treatment - Your heart, liver, kidney, and other organ functions are in acceptable ranges **You may NOT be eligible if...** - Your cancer cells do not show the CD123 protein marker - You have serious heart problems (ejection fraction below normal) - Your liver, kidney, or albumin (blood protein) levels are outside the required ranges - You have an active, uncontrolled infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzacitidine

Chemotherapy

DRUGSL-401

SL-401 works by targeting leukemia cells (blasts), and also possibly by stopping or slowing the growth of cancer stem cells, which are the undeveloped cells which can develop into cancer cells.

DRUGVenetoclax

Venetoclax is a BH3-mimetic. Venetoclax blocks the anti-apoptotic B-cell lymphoma-2 (Bcl-2) protein, leading to programmed cell death of CLL cells. Overexpression of Bcl-2 in some lymphoid malignancies has sometimes shown to be linked with increased resistance to chemotherapy.


Locations(3)

City of Hope

Duarte, California, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT03113643


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