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A Phase 3 Extension Study of Duvelisib and Ofatumumab in Participants With CLL/SLL Previously Enrolled in Study IPI-145-07

NCT02049515 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2023-09-21

Study results available
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Summary

A Phase 3 (extension) clinical trial to examine the efficacy of IPI-145 (duvelisib) monotherapy or ofatumumab monotherapy in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who experienced disease progression after treatment with IPI-145 or ofatumumab in study IPI-145-07 (NCT02004522).

Conditions

Interventions

DRUG

IPI-145

PI3K Inhibitor

DRUG

Ofatumumab

Monoclonal antibody

Sponsors & Collaborators

  • SecuraBio

    lead INDUSTRY

Principal Investigators

  • Hagop Youssoufian, MD · Verastem, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2020-06-12
Completion
2020-06-12

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • France
  • Germany
  • Hungary
  • Italy
  • New Zealand
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT02049515 on ClinicalTrials.gov