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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
No Placebo-Only Group

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 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%
SARS-CoV-2 test positive
11%
Sepsis
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%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~2650
Prednisone
2014
Completed Phase 4
~2500
Cytarabine
2016
Completed Phase 3
~4020
Cyclophosphamide
2010
Completed Phase 4
~2310
Methotrexate
2019
Completed Phase 4
~4400
Doxorubicin
2012
Completed Phase 3
~8030
Mercaptopurine
2012
Completed Phase 4
~13290
Venetoclax
2019
Completed Phase 3
~2240
Vincristine
2003
Completed Phase 4
~2970
Rituximab
1999
Completed Phase 4
~2990
Methylprednisolone
2015
Completed Phase 4
~2280

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,505 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,540 Total Patients Enrolled
Naveen PemmarajuPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
128 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
~12 spots leftby Dec 2026
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