A Study of Duvelisib and Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Indolent or Aggressive Non-Hodgkin Lymphoma, Who Have Not Previously Received a Bcl-2 or PI3K Inhibitor

Part of paid clinical trials in Tucson, Arizona.

Sponsor
AbbVie
Study ID
NCT02640833
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Duvelisib — DRUG
    Duvelisib will be taken continuously. This is a defining dose study, therefore the dose of Duvelisib may change.
  • Venetoclax — DRUG
    Venetoclax will be taken continuously. This is a defining dose study, therefore the dose of Venetoclax will change.

Study Details

This study is designed to assess the safety, pharmacokinetics, drug-drug interactions, and determine the recommended Phase 2 doses of co administered Duvelisib and Venetoclax in participants with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma, or indolent or aggressive non-Hodgkin lymphoma, who have not previously received a Bcl-2 or Phosphoinositide 3-kinase (PI3K) inhibitor. The Phase 2 portion of the study will preliminarily evaluate efficacy, and expand the toxicity evaluation.

Key Dates

Start date
Jul 31, 2016
Status verified
Jul 2016
Primary completion
Jan 31, 2020
Completion
Feb 28, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Duvelisib+Venetoclax

Primary Outcome Measure

Number of participants with adverse events [ Time Frame: From participant's first dose until 30 days after participant's last dose of study drug; up to 2 years following last participant first dose ]

Locations (10)

FacilityCityStateZIPSite coordinators
Site Reference ID/Investigator# 145677TucsonArizona85724-5024-
Site Reference ID/Investigator# 147922ChicagoIllinois60611-
Site Reference ID/Investigator# 148562HarveyIllinois60426-
Site Reference ID/Investigator# 148561GoshenIndiana46526-
Site Reference ID/Investigator# 145674BaltimoreMaryland21287-
Site Reference ID/Investigator# 145145BostonMassachusetts02215-
Site Reference ID/Investigator# 148010DetroitMichigan48202-
Site Reference ID/Investigator# 147747St LouisMissouri63110-
Site Reference ID/Investigator# 145146LebanonNew Hampshire03756-
Site Reference ID/Investigator# 148559GreenvilleSouth Carolina29605-

Find similar trials in Tucson, AZ

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Site Reference ID/Investigator# 145677· Tucson, AZSite Reference ID/Investigator# 147922· Chicago, ILSite Reference ID/Investigator# 148562· Harvey, ILSite Reference ID/Investigator# 148561· Goshen, INSite Reference ID/Investigator# 145674· Baltimore, MDSite Reference ID/Investigator# 145145· Boston, MA

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