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Chemotherapy Agent

Venetoclax + Tagraxofusp-erzs + Chemotherapy for BPDCN

Phase 2

Recruiting

Led By Naveen Pemmaraju

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed diagnosis of blastic plasmacytoid dendritic cell neoplasm (BPDCN) per 2016 World Health Organization (WHO) criteria

Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

Must not have

Prior treatment with VEN

Symptomatic or untreated leptomeningeal disease or spinal cord compression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

Summary

This trial is studying how well venetoclax, SL-401, and chemotherapy work in treating patients with blastic plasmacytoid dendritic cell neoplasm.

Who is the study for?

This trial is for adults with a confirmed diagnosis of blastic plasmacytoid dendritic cell neoplasm. Participants should be in relatively good health (ECOG status 0-2), have normal heart function, and agree to use effective contraception. People who've had major surgery or certain treatments recently, are pregnant or breastfeeding, have active hepatitis B/C or HIV, severe heart issues, malabsorption syndrome, untreated brain/spinal cord problems, or prior venetoclax treatment can't join.

What is being tested?

The study tests the effectiveness of combining venetoclax and SL-401 with standard chemotherapy in treating blastic plasmacytoid dendritic cell neoplasm. Venetoclax targets enzymes needed for tumor growth; SL-401 delivers a toxin directly to tumor cells via IL-3 receptors; chemotherapy aims to kill or stop cancer cells from growing and spreading.

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as fever and fatigue; organ inflammation; blood count changes leading to increased infection risk; nausea; liver enzyme alterations that may affect liver function; allergic reactions specific to the drugs used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diagnosis is BPDCN, confirmed by a biopsy.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

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

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I have previously been treated with VEN.

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I have symptoms or untreated spinal cord or brain lining issues.

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I do not have severe heart disease or recent major heart events.

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I do not have active hepatitis B or C, nor am I HIV positive.

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I have not had major surgery or radiation therapy in the last 14 days.

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I cannot take medications by mouth due to a digestive condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 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

Incidence of adverse events

Overall response rate

Progression free survival (PFS)

+1 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471

33%

Neutropenia

11%

Sepsis

11%

SARS-CoV-2 test positive

11%

Abdominal pain

11%

Pneumonia

11%

Rhinovirus infection

11%

COVID-19

11%

Gastroenteritis

11%

Pneumonia pseudomonal

11%

Electrocardiogram QT prolonged

11%

Anaemia

11%

Neutrophil count decreased

11%

Hypokalaemia

11%

Febrile neutropenia

11%

Supraventricular tachycardia

11%

Blood creatinine increased

11%

White blood cell count decreased

11%

Dermatitis

100%

80%

60%

40%

20%

Study treatment Arm

Bendamustine + Rituximab Crossover Substudy

Venetoclax + Rituximab Re-Treatment Substudy

Venetoclax + Rituximab Main Study

Bendamustine + Rituximab Main Study

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (SL-401, venetoclax, chemotherapy)Experimental Treatment12 Interventions

See detailed description.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2640

Prednisone

2014

Completed Phase 4

~2500

Cytarabine

2016

Completed Phase 3

~3330

Cyclophosphamide

2010

Completed Phase 4

~2320

Methotrexate

2019

Completed Phase 4

~4400

Doxorubicin

2012

Completed Phase 3

~8030

Mercaptopurine

2012

Completed Phase 4

~12550

Venetoclax

2019

Completed Phase 3

~2200

Vincristine

2003

Completed Phase 4

~2970

Rituximab

1999

Completed Phase 4

~2200

Methylprednisolone

2015

Completed Phase 4

~2280

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

3,039 Previous Clinical Trials

1,799,661 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,842 Previous Clinical Trials

41,002,960 Total Patients Enrolled

Naveen PemmarajuPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

93 Total Patients Enrolled

Media Library

Cyclophosphamide (Chemotherapy Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04216524 — Phase 2

Blastic Plasmacytoid Dendritic Cell Neoplasm Research Study Groups: Treatment (SL-401, venetoclax, chemotherapy)

Blastic Plasmacytoid Dendritic Cell Neoplasm Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT04216524 — Phase 2

Cyclophosphamide (Chemotherapy Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04216524 — Phase 2

~14 spots leftby Dec 2026

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