Duvelisib and Venetoclax in Relapsed or Refractory CLL or SLL
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|ClinicalTrials.gov Identifier: NCT03534323|
Recruitment Status : Recruiting
First Posted : May 23, 2018
Last Update Posted : July 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: Duvelisib Drug: Venetoclax||Phase 1 Phase 2|
This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of an investigational drugs and also tries to define the appropriate dose of the investigational drugs to use for further studies. "Investigational" means that the drugs are being studied together for the first time.
This phase I study tests the safety of the drug duvelisib when used in combination with the drug venetoclax. Since duvelisib is still being studied, the FDA (the U.S. Food and Drug Administration) has not approved duvelisib as a treatment for any disease.
Duvelisib is a drug that is given in capsule form and taken by mouth. This drug is designed to stop cancer growth by blocking a protein called phosphatidylinositide 3-kinase (PI3K), which is important for the survival of CLL cells. In laboratory studies and in other clinical trials that included participants with CLL, duvelisib was effective at killing CLL cells.
Venetoclax is a tablet that is taken by mouth. Venetoclax targets a protein called BCL-2, which helps cancer cells survive. Venetoclax is an effective treatment for many participants with CLL who do not respond to chemotherapy or other approved drugs or who have relapsed after prior therapy. Venetoclax is FDA approved for participants with CLL who have a genetic changes (called a deletion 17p abnormality) and have had their CLL worsen after at least one prior therapy for their CLL.
In the phase I portion of this study, the investigators are looking to determine the dose of venetoclax that is safe to give with duvelisib and to see what the side effects are of this combination.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Duvelisib and Venetoclax in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma|
|Actual Study Start Date :||July 12, 2018|
|Estimated Primary Completion Date :||June 1, 2022|
|Estimated Study Completion Date :||June 1, 2024|
Experimental: Duvelisib +Venetoclax,
Duvelisib will be given alone for the first seven days. On day 8 Venetoclax will be added.
This drug is designed to stop cancer growth by blocking a protein called phosphatidylinositide 3-kinase (PI3K), which is important for the survival of CLL cells.
Other Name: IPI-145
Venetoclax targets a protein called BCL-2, which helps cancer cells survive.
Other Name: Venclexta
- Maximum Tolerated Dose of Venetoclax When Administered with Duvelisib [ Time Frame: Up to 7 weeks ]As assessed by protocol-specified DLT criteria (phase I)
- Rate of complete remission [ Time Frame: 2 years ]By IW-CLL criteria (phase II)
- Cmax [ Time Frame: Up to 7 weeks ]Cmax
- Half-life [ Time Frame: Up to 7 weeks ]Half-life
- Volume of Distribution [ Time Frame: Up to 7 weeks ]Volume of Distribution
- Objective response rate [ Time Frame: 2 years ]By IW-CLL Criteria
- Duration of response [ Time Frame: 2 years ]By IW-CLL Criteria
- Progression free survival [ Time Frame: 2 years ]By IW-CLL Criteria
- Rate of minimal residual disease negativity [ Time Frame: 2 years ]By IW-CLL Criteria
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): NCT03534323
|Contact: Alexandra Savellfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Jacob Soumerai, MD 617-726-2865 email@example.com|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Jon Arnason, MD 617-667-9920 firstname.lastname@example.org|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Matthew Davids, MD|
|Contact: Alexandra Savell 617-632-3539 email@example.com|
|Principal Investigator: Matthew S Davids, MD|
|Principal Investigator:||Matthew S Davids, MD||Dana-Farber Cancer Institute|