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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03639324
Other study ID # MCC-15-12310
Secondary ID NCI-2018-01661
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date October 2, 2020
Est. completion date October 18, 2021

Study information

Verified date November 2021
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the recommended phase 2 dose (RP2D) of idelalisib and venetoclax in combination with rituximab in patients with relapsed or refractory Chronic lymphocytic leukemia/ Small lymphocytic lymphoma (CLL/SLL) following a lead-in period with idelalisib and rituximab


Description:

This phase 1, multicenter, dose-escalation study is designed to find the Recommended Phase 2 Dose (RP2D) of idelalisib and venetoclax in combination with rituximab in patients with relapsed or refractory CLL/SLL and to assess the clinical activity of the combination with rituximab in patients with relapsed or refractory CLL/SLL and to assess the clinical activity of the combination.


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Study Design


Related Conditions & MeSH terms

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Intervention

Drug:
Dose combination 1-1
100 mg QD of idelalisib + 100 mg QD of venetoclax
dose combination 1-2
100 mg QD of idelalisib + 200 mg QD of venetoclax
Dose combination 1-3
100 mg BID of idelalisib + 200 mg QD of venetoclax
dose combination 1-4
150 mg BID of idelalisib + 200 mg QD of venetoclax
Sub-Trial: Dose combination 2-1
100 mg BID of idelalisib + 100 mg QD of venetoclax
Sub-Trial: Dose combination 2-2
150 mg BID of idelalisib + 100 mg QD of venetoclax

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Virginia Commonwealth University Gilead Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary Find the RP2D of idelalisib and venetoclax in combination with rituximab in patients with relapsed or refractory chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL) Determine the recommended phase 2 dose of idelalisib and venetoclax in combination with rituximab in patients with relapsed or refractory CLL/SLL following a lead-in period with idelalisib and rituximab. 41 Months
Secondary Safety Evaluation: Determine adverse events (AEs) reported using criteria in the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 Observed adverse events of treatment with idelalisib and venetoclax in combination with rituximab in patients with relapsed or refractory CLL/ SLL following a lead-in period with idelalisib and rituximab utlizing CTCAE Version 5.0 63 Months
Secondary Determination of cumulative complete response (CR) rate. Determine the cumulative CR rate to the study regimen at 7 and 13 months using the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria. 52 Months
Secondary Summarize the objective response rate. Determine the cumulative overall disease response to the study regimen at 7 and 13 months using the 2008 IWCLL criteria. 52 Months
Secondary Minimal residual disease (MRD) rate Estimate the rate of undetectable minimal residual disease (MRD) status for idelalisib and venetoclax in combination with rituximab using 4-color flow cytometry in peripheral blood and/or bone marrow for responding patients 52 Months
Secondary Overall Survival Rate determine the OS rate (at 24 months following initiation of venetoclax) for idelalisib and venetoclax in combination with rituximab. 63 Months
Secondary Progression Free Survival Rate Determine the progression-free survival (PFS) rate (at 24 months following initiation of venetoclax) for idelalisib and venetoclax in combination with rituximab 63 Months
Secondary Pharmacokinetics of the combination of idelalisib and venetoclax. 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)] 7 Years
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