Duvelisib and Venetoclax in Relapsed or Refractory CLL or SLL or RS
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|ClinicalTrials.gov Identifier: NCT03534323|
Recruitment Status : Recruiting
First Posted : May 23, 2018
Last Update Posted : May 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia Richter Syndrome||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. Duvelisib is still being studied, but the FDA (the U.S. Food and Drug Administration) has approved the use of Duvelisib in patients with CLL/SLL with relapsed or refractory CLL after having received 2 or more prior therapies.
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 never had therapy before or whose CLL has worsened after prior therapy.
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.
In the phase II portion of this study, we are looking to determine how effective thecombination of duvelisib and venetoclax is for patients with CLL or Richter's Syndrome
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||67 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 or Patients With Richter's Syndrome|
|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, Florida|
|University of Miami- Sylvester Comprehensive Cancer Center||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Alvaro Alencar, MD|
|Contact: Nathalie Luis|
|United States, Maine|
|Northern Light Eastern Maine Medical Center||Recruiting|
|Brewer, Maine, United States, 04412|
|Contact: Allan L Cruz, MD|
|Contact: Laurie Lewis|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Jacob Soumerai, MD 617-726-2865 email@example.com|
|Boston Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02118|
|Contact: Mark Sloan, MD|
|Contact: Salli Fennessey|
|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|
|Berkshire Medical Center||Recruiting|
|Pittsfield, Massachusetts, United States, 01201|
|Contact: Michael DeLeo, MD|
|Contact: Jessica Ziemek|
|Principal Investigator:||Matthew S Davids, MD||Dana-Farber Cancer Institute|