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 : October 16, 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 :||November 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)]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639324
|Contact: Victor Y Yazbek, MD, MSemail@example.com|
|Contact: Caryn R Weir, RN, M.P.H.||firstname.lastname@example.org|
|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 email@example.com|
|Contact: Caryn R Weir, RN, M.P.H. 804-628-2310 firstname.lastname@example.org|
|Principal Investigator:||Victor Y Yazbek, MD, MS||Massey Cancer Center|