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)

Part of paid clinical trials in Duarte, California.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03113643
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine — DRUG
    Chemotherapy
  • SL-401 — DRUG
    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.
  • Venetoclax — DRUG
    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.

Study Details

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

Key Dates

Start date
Jun 26, 2017
Status verified
Nov 2025
Primary completion
May 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SL-401+ Azacitidine
    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
  • Experimental: SL-401+ Azacitidine + Venetoclax
    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

Primary Outcome Measure

Maximum Tolerated Dose [ Time Frame: 2 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Anthony Stein, MD
[email protected]
626-359-8111
Anthony Stein, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Andrew Lane, MD, PhD
[email protected]
Veronica Zehnder
[email protected]
Andrew Lane, MD, PhD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Naveen Pemmaraju, MD
[email protected]
713-792-4956
Naveen Pemmaraju, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
City of Hope· Duarte, CADana Farber Cancer Institute· Boston, MAMD Anderson Cancer Center· Houston, TX

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