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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My BPDCN has not improved or has returned after at least one treatment (not counting hydroxyurea).
Select...
My diagnosis is BPDCN, confirmed by a biopsy.
Select...
I am older than 18 years.
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I can take care of myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Limiting Toxicity
Secondary outcome measures
Complete Response
Overall Response Rate
Overall Survival
+2 moreSide effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
Hypokalaemia
11%
Dermatitis
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
COVID-19
11%
Supraventricular tachycardia
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
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
~1990
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,981 Total Patients Enrolled
AbbVieIndustry Sponsor
958 Previous Clinical Trials
502,390 Total Patients Enrolled
Andrew Lane, MDPrincipal Investigator - Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My BPDCN has not improved or has returned after at least one treatment (not counting hydroxyurea).I have BPDCN, have tried at least one treatment (not hydroxyurea), or am over 75 years old and haven't started treatment, or am over 18 and can't or won't do intensive chemotherapy.I have been treated with venetoclax before.I haven't had cancer treatment in the last 14 days, except for hydroxyurea.I do not have any active advanced cancers, except for certain skin cancers or cancers that are contained and not spread.I am not pregnant or breastfeeding.I have an infection, but it is under control with medication.My diagnosis is BPDCN, confirmed by a biopsy.I am older than 18 years.I can take care of myself and perform daily activities.I have not had a stem cell transplant or been on immunosuppressive therapy for graft-versus-host disease in the last 60 days.I do not have severe heart or lung conditions, and haven't had a heart attack or stroke in the last 6 months.My kidney and liver functions are within the required limits.I can take pills and do not have major issues with my digestive system.I haven't taken strong or moderate CYP3A affecting drugs in the last week.I have HIV, active hepatitis B, or hepatitis C.My BPDCN cancer has spread to my brain.
Research Study Groups:
This trial has the following groups:- Group 1: Venetoclax
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being enrolled in this medical experiment?
"This trial is not recruiting at the moment, having been first posted on August 23rd 2018 and last edited on April 18th 2022. However, there are presently 2383 clinical trials actively seeking patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) as well as 219 studies related to Venetoclax that have open recruitment slots."
Answered by AI
Is this research currently recruiting participants?
"The clinicaltrials.gov database indicates that this trial, first posted on August 23rd 2018 and last updated April 18th 2022, is not presently seeking patients. Nevertheless, there are still 2,602 other trials available to potential participants at the moment."
Answered by AI
Has the FDA issued a permit for Venetoclax?
"The safety of Venetoclax is ranked as a 1 on our team's scale, due to the fact that we are only just in Phase 1 and there is limited data demonstrating its efficacy."
Answered by AI
Has Venetoclax been studied in any preceding experiments?
"Presently, there are 219 active trials for Venetoclax with 28 in the final phase. Of these clinical studies, 7198 locations across the planet have opened their doors to patients seeking treatment. Notably, several of them reside in Boston, Massachusetts."
Answered by AI
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