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BCL2 Antagonist

Venetoclax for Blastic Plasmacytoid Dendritic Cell Neoplasm

Phase 1

Waitlist Available

Led By Andrew Lane, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

In Stage 1 (modified 3+3): BPDCN relapsed after or refractory to at least one prior treatment regimen (hydroxyurea is not considered a prior treatment regimen)

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

Must not have

Prior treatment with venetoclax

Hematopoietic stem cell transplantation (HSCT) within 60 days of first protocol treatment, or receipt of immunosuppressive therapy for graft-versus-host disease treatment or prophylaxis within 14 days of first protocol treatment, or active graft-versus-host-disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well venetoclax works in treating patients with BPDCN.

Who is the study for?

This trial is for adults over 18 with BPDCN that's come back or didn't respond to treatment, except hydroxyurea. They must have decent organ function and be able to consent. Women who can have babies and men must use birth control during the study. It's also open to those over 75 or unfit for intensive chemo.

What is being tested?

The trial is testing Venetoclax as a potential treatment for BPDCN. Participants will receive this drug to see how effective it is against their condition.

What are the potential side effects?

Venetoclax may cause side effects like nausea, diarrhea, low blood cell counts increasing infection risk, tiredness, and in some cases pneumonia or other serious infections.

Eligibility Criteria

Inclusion Criteria

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

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My BPDCN has not improved or has returned after at least one treatment (not counting hydroxyurea).

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My diagnosis is BPDCN, confirmed by a biopsy.

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I am older than 18 years.

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I can take care of myself and perform daily activities.

Exclusion Criteria

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

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I have been treated with venetoclax before.

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I have not had a stem cell transplant or been on immunosuppressive therapy for graft-versus-host disease in the last 60 days.

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I do not have severe heart or lung conditions, and haven't had a heart attack or stroke in the last 6 months.

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I do not have any active advanced cancers, except for certain skin cancers or cancers that are contained and not spread.

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I am not pregnant or breastfeeding.

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I have HIV, active hepatitis B, or hepatitis C.

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My BPDCN cancer has spread to my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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%

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: VenetoclaxExperimental Treatment1 Intervention

* Venetoclax is administered on a daily basis orally. * The investigators will use a modified 3+3 with a de-escalation dose level design to establish the appropriate and tolerable dose of venetoclax.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~2240

0 / 11Eligibility criteria met