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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My diagnosis is BPDCN, confirmed by a biopsy.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Overall response rate
Progression free survival (PFS)
+1 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: 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
~2590
Prednisone
2014
Completed Phase 4
~2370
Cytarabine
2016
Completed Phase 3
~3310
Cyclophosphamide
1995
Completed Phase 3
~3770
Methotrexate
2013
Completed Phase 4
~3800
Doxorubicin
2012
Completed Phase 3
~7940
Mercaptopurine
2012
Completed Phase 4
~12330
Venetoclax
2019
Completed Phase 3
~1990
Tagraxofusp-erzs
2020
Completed Phase 2
~10
Vincristine
2003
Completed Phase 4
~2910
Rituximab
1999
Completed Phase 4
~1880
Methylprednisolone
2015
Completed Phase 4
~2280
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,321 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,814 Total Patients Enrolled
Naveen PemmarajuPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
93 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy, radiotherapy, or experimental treatments in the last 14 days, except for specific allowed medications.I have previously been treated with VEN.I have taken or am taking ARA-C or hydroxyurea for BPDCN.My diagnosis is BPDCN, confirmed by a biopsy.My heart's pumping ability is within the normal range.You have a serious medical or mental health condition that could make participating in the study risky or affect the study results.I may have had one round of specific treatment for BPDCN before joining this study.I have symptoms or untreated spinal cord or brain lining issues.I do not have severe heart disease or recent major heart events.I do not have active hepatitis B or C, nor am I HIV positive.I can take care of myself and am up and about more than half of my waking hours.I have not had major surgery or radiation therapy in the last 14 days.I cannot take medications by mouth due to a digestive condition.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (SL-401, venetoclax, chemotherapy)
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.
What other research forays have been undertaken utilizing Venetoclax?
"Presently, there are 2,281 research initiatives involving Venetoclax with 496 located in their final phase. While the primary location for such investigations is based out of Joliet, Illinois; 75269 other trial sites also offer this medication as an option to patients."
Answered by AI
Does Venetoclax present any significant risk to participants?
"Our team has judged that the safety of Venetoclax is a 2, given its Phase 2 trial status. This means there is evidence for safety but not efficacy."
Answered by AI
Are there opportunities for enrolment in this clinical experimentation?
"Affirmative. From the information hosted on clinicaltrials.gov, it is evident that this medical trial - which was initially posted on May 29th 2020 - is still seeking participants. 40 patients are required to be enrolled from one specific site."
Answered by AI
What clinical indications does Venetoclax typically address?
"Venetoclax is mainly prescribed for macular edema, but can also be an appropriate treatment for pheochromocytomas, eye-related issues, and ulcerative colitis."
Answered by AI
How many participants are expected to be part of this medical study?
"Affirmative, clinicaltrials.gov attests that this research endeavour is currently searching for participants. It was first made public on May 29th 2020 and most recently updated on September 22nd 2022. A total of 40 patients at 1 site must be recruited to participate in the study."
Answered by AI
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