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Venetoclax, SL-401, and Chemotherapy for Blastic Plasmacytoid Dendritic Cell Neoplasm

This study is looking at how well a combination of venetoclax, SL-401, and chemotherapy works for people with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare blood cancer. Venetoclax may stop cancer cells from growing. SL-401 is designed to target and kill cancer cells by delivering a toxic agent directly to them. Chemotherapy drugs work in different ways to stop cancer cell growth. Researchers hope this combination will be an effective treatment. The study is open to adults aged 18 and older who have BPDCN, whether they are newly diagnosed or have had treatment before. The study aims to enroll 40 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 40 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 6 years to check for progression-free survival, side effects, and overall response to treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04216524

Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~40 participants
Updated 2026-04-14 on ClinicalTrials.gov
What's tested:CyclophosphamideCytarabineDexamethasoneDoxorubicinMercaptopurineMethotrexate

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS)
Measured over Up to 6 years
+3 more outcomes measured

Conditions

Blastic Plasmacytoid Dendritic Cell Neoplasm

Explore related trials

Blastic Plasmacytoid Dendritic Cell Neoplasm

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Naveen Pemmaraju · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Naveen Pemmaraju
[email protected]
713-792-4956
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Albumin ≥ 3.2 g/dL (in the absence of receipt of intravenous albumin in the previous 72 hours)
Serum creatinine \< 1.5x ULN
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5x ULN
Total bilirubin \< 1.5x ULN (if total bilirubin is \> 1.5x but \< 3x ULN, and thought to be elevated due to Gilbert's disease or the patient's BPDCN, the subject may be eligible but must discuss with the PI) 7. Ability to understand and the willingness to sign a written informed consent document. 8. Able to adhere to study visit schedule and other protocol requirements including follow-up for survival assessment 9. Women of child-bearing potential and men enrolled on this protocol must agree to use adequate contraception for the duration of study participation and for 2 months after completion VEN administration. Acceptable birth control methods allowed to be used while on study include:
Birth control pills or injections
Intrauterine devices (IUDs)
Double-barrier methods for example condom in combination with spermicide. Males should not donate sperm while on study and for at least 8 weeks after the last dose of SL-401. 10. Left ventricular ejection fraction ≥ institutional lower limit of normal by MUGA scan or echocardiogram within 30 days of first protocol treatment.

What this trial measures

  • Progression free survival (PFS)Up to 6 years

    The median PFS time will be estimated by Bayesian posterior estimates. Estimated using the Kaplan-Meier method.

  • Incidence of adverse eventsUp to 6 years

    Will be reported by type, frequency and severity. Highest toxicity grades per patient per course will be tabulated for selected adverse events and laboratory measurements.

  • Overall response rateUp to 6 years

    Overall response rate along with complete remission and complete remission with incomplete hematologic recovery will be estimated along with 95% confidence interval.

  • Rate of stem cell transplantUp to 6 years

    The response rate will be compared between subgroups (e.g. minimal residual disease negativity, etc.) by Fisher's exact test, and Wilcoxon rank test will be used to compare the patient clinical information (e.g., protein expression) between subgroups such as response and non-response.