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

NCT03639324 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-11-09

No results posted yet for this study

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

Conditions

Interventions

DRUG

Dose combination 1-1

100 mg QD of idelalisib + 100 mg QD of venetoclax

DRUG

dose combination 1-2

100 mg QD of idelalisib + 200 mg QD of venetoclax

DRUG

Dose combination 1-3

100 mg BID of idelalisib + 200 mg QD of venetoclax

DRUG

dose combination 1-4

150 mg BID of idelalisib + 200 mg QD of venetoclax

DRUG

Sub-Trial: Dose combination 2-1

100 mg BID of idelalisib + 100 mg QD of venetoclax

DRUG

Sub-Trial: Dose combination 2-2

150 mg BID of idelalisib + 100 mg QD of venetoclax

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Victor Y Yazbek, MD, MS · Massey Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-02
Primary Completion
2021-10-18
Completion
2021-10-18
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03639324 on ClinicalTrials.gov