Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT03639324

Rituximab, Idelalisib, and Venetoclax in Relapsed/Refractory CLL/SLL

Phase 1 Trial of Rituximab, Idelalisib, and Venetoclax in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (RIVe-CLL/SLL)

Status
Withdrawn
Phase
Phase 1
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Virginia Commonwealth University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Detailed 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.

Conditions

Interventions

TypeNameDescription
DRUGDose combination 1-1100 mg QD of idelalisib + 100 mg QD of venetoclax
DRUGdose combination 1-2100 mg QD of idelalisib + 200 mg QD of venetoclax
DRUGDose combination 1-3100 mg BID of idelalisib + 200 mg QD of venetoclax
DRUGdose combination 1-4150 mg BID of idelalisib + 200 mg QD of venetoclax
DRUGSub-Trial: Dose combination 2-1100 mg BID of idelalisib + 100 mg QD of venetoclax
DRUGSub-Trial: Dose combination 2-2150 mg BID of idelalisib + 100 mg QD of venetoclax

Timeline

Start date
2020-10-02
Primary completion
2021-10-18
Completion
2021-10-18
First posted
2018-08-21
Last updated
2021-11-09

Regulatory

Source: ClinicalTrials.gov record NCT03639324. Inclusion in this directory is not an endorsement.