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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)

ConditionsAcute Myeloid LeukemiaMyelodysplastic SyndromeBlastic Plasmacytoid Dendritic Cell Neoplasm
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: SL-401+ AzacitidineExperimental treatment 2 interventions
Group B: SL-401+ Azacitidine + VenetoclaxExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Maximum Tolerated Dose

To determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of SL-401 in combination with azacitidine or in combination with azacitidine and venetoclax in this patient population and evaluate the safety of this regimen

Time frame
2 years

Secondary outcomes

1

Complete Response Rate

To estimate the complete remission (CR) / CR with incomplete count recovery (CRi) rate within 6 cycles of combination therapy consisting of SL-401 administered with azacitidine or in combination with azacitidine and venetoclax in subjects with AML and high-risk MDS

Time frame
2 years
2

Time to response

To estimate the time to response with SL-401 in combination with azacitidine or in combination with azacitidine and venetoclax

Time frame
2 years
3

Duration of remission

To estimate the duration of remission with SL-401 in combination with azacitidine or in combination with azacitidine and venetoclax

Time frame
2 years
4

Progression Free Survival

To estimate the 1 and 2-year progression free survival (PFS) with SL-401 in combination with azacitidine or in combination with azacitidine and venetoclax

Time frame
1 and 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dana-Farber Cancer Institute

Lead sponsor

Stemline Therapeutics, Inc.

Collaborator

Source ClinicalTrials.gov
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