Study of Venetoclax, a BCL2 Antagonist, for Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03485547|
Recruitment Status : Active, not recruiting
First Posted : April 2, 2018
Last Update Posted : April 25, 2022
This research study is studying a drug as a possible treatment for BPDCN.
The intervention involved in this study is: Venetoclax
|Condition or disease||Intervention/treatment||Phase|
|Blastic Plasmacytoid Dendritic Cell Neoplasm||Drug: Venetoclax||Phase 1|
This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the safest dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved venetoclax for this specific disease but it has been approved for other uses.
Based on laboratory data where it was found that BPDCN cells die after treatment with Venetoclax, the investigators believe that this drug will be effective in treating patients with BPDCN.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study of Venetoclax, a BCL2 Antagonist, for Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)|
|Actual Study Start Date :||August 23, 2018|
|Estimated Primary Completion Date :||January 19, 2023|
|Estimated Study Completion Date :||January 19, 2023|
VENCLEXTA targets BCL-2 in order to help restore the process of apoptosis. Through apoptosis, your body allows cancer cells and normal cells to self-destruct
Other Name: Venclexta
- Dose Limiting Toxicity [ Time Frame: 2 years ]
- Overall Response Rate [ Time Frame: 2 years ]
- Complete Response [ Time Frame: 2 years ]
- Partial Response [ Time Frame: 2 years ]
- Overall Survival [ Time Frame: 2 years ]
- Progression free survival [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03485547
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Andrew Lane, MD||Dana-Farber Cancer Institute|