Rituximab, Idelalisib, and Venetoclax in Relapsed/Refractory CLL (RIVe-CLL)
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|ClinicalTrials.gov Identifier: NCT03639324|
Recruitment Status : Not yet recruiting
First Posted : August 21, 2018
Last Update Posted : April 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia CLL Relapsed CLL Refractory Chronic Lymphocytic Leukemia Relapsed Chronic Lymphocytic Leukemia||Drug: Rituximab, Idelalisib, and Venetoclax||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients will start on dose level 1 of venetoclax in combination with rituximab and idelalisib, then escalate or de-escalate (if lower dose is available) based upon the estimated probabilities of toxicity from an extension of the continual reassessment method for 2 agents.|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Trial of Rituximab, Idelalisib, and Venetoclax in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (RIVe-CLL)|
|Estimated Study Start Date :||June 30, 2019|
|Estimated Primary Completion Date :||March 30, 2022|
|Estimated Study Completion Date :||September 30, 2025|
Experimental: Rituximab, Idelalisib, & Venetoclax
Idelalisib 50, 100, or 150 mg PO BID; venetoclax 100 or 200 mg daily; rituximab per standard of care during the lead-in phase and then 500 mg/m2 IV every 4 weeks x 6 doses during the treatment phase
Drug: Rituximab, Idelalisib, and Venetoclax
Patients will start on dose level 1, then escalate or de-escalate (if lower dose is available) based upon the estimated probabilities of toxicity from an extension of the continual reassessment method for 2 agents.
Other Name: Rituxan, Venclexta
- Recommended Phase 2 Dose (RP2D) of idelalisib and venetoclax in combination with rituximab [ Time Frame: 7 Years ]Recommended phase 2 dose of idelalisib and venetoclax in combination with rituximab in patients with relapsed or refractory CLL following a lead-in period with idelalisib and rituximab.
- Safety Evaluation: Determine adverse events (AEs) reported using criteria in the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [ Time Frame: 7 Years ]Observed adverse events of treatment with idelalisib and venetoclax in combination with rituximab in patients with relapsed or refractory CLL following a lead-in period with idelalisib and rituximab utlizing CTCAE Version 4.0
- Determination of cumulative complete response (CR) rate. [ Time Frame: 7 Years ]Determine the cumulative CR rate to the triple-drug combination at 7 and 13 months using the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria.
- Summarize objective response rate. [ Time Frame: 7 Years ]Determine the cumulative overall disease response to the triple-drug combination at 7 and 13 months using the 2008 IWCLL criteria.
- Minimal residual disease (MRD) rate [ Time Frame: 7 Years ]To determine Minimal Residual Disease (MRD) negativity status in peripheral blood and/or bone marrow after achieving an objective response using 4-color flow cytometry in peripheral blood and/or bone marrow for responding patients.
- Survival Rate [ Time Frame: 7 Years ]Determine the proportion of patients who are alive at 24 months following initiation of venetoclax.
- Pharmacokinetics of the combination of idelalisib and venetoclax. [ Time Frame: 7 Years ]Determine the idelalisib and venetoclax plasma concentrations measured at designated time points throughout the study: pre-Tx; C1D1; C1D15; C1D22; C1D29; C3D1; C7D22; C13D222; at DLT (if feasible); at relapse (if feasible)]
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): NCT03639324
|Contact: Victor Y Yazbek, MD, MSfirstname.lastname@example.org|
|Contact: Caryn R Weir, RN, M.P.H.||email@example.com|
|United States, Virginia|
|Virginia Commonwealth University/ Massey Cancer Center||Not yet recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: Yazbeck Y Victor, MD, MS 804-628-2073 firstname.lastname@example.org|
|Contact: Caryn R Weir, RN, M.P.H. 804-628-2310 email@example.com|
|Principal Investigator:||Victor Y Yazbek, MD, MS||Massey Cancer Center|