A Study to Evaluate the Efficacy of Venetoclax Monotherapy in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL)

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
AbbVie
Study ID
NCT02756611
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Venetoclax — DRUG
    Tablets for oral administration

Study Details

The purpose of this study is to evaluate the efficacy of venetoclax monotherapy in participants with relapsed/refractory CLL with or without the 17p deletion or TP53 mutation, including those who have received prior treatment with a B-cell receptor inhibitor.

Key Dates

Start date
Jun 22, 2016
Status verified
Apr 2023
Primary completion
Apr 10, 2019
Completion
Mar 11, 2022

Study Design

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

Arms

  • Experimental: Venetoclax
    Venetoclax will be administered orally once daily (QD) beginning with a dose-titration phase. The initial venetoclax dose is 20 mg QD. After 1 week of treatment at 20 mg QD, the dose will be escalated to 50 mg QD followed by subsequent increases, each after 1 week, to 100 mg QD, 200 mg QD and the maximum dose of 400 mg QD. Participants may continue to receive venetoclax for up to 2 years provided they continue to tolerate the drug, have no evidence of disease progression (based on investigator's assessment), do not have unacceptable toxicity, and do not meet any of the criteria for discontinuation. In countries where venetoclax is not commercially available, participants who continue to derive benefit after 2 years of treatment may be able to extend their treatment for up to 2 additional years, plus one additional year until the venetoclax extension study was open, determined on a case by case basis.

Primary Outcome Measure

Complete Remission Rate in Participants Not Previously Treated With BCRi Therapy - Primary Analysis [ Time Frame: From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months. ]

Locations (6)

FacilityCityStateZIPSite coordinators
Norton Cancer Institute /ID# 149788LouisvilleKentucky40202-3700-
St. Agnes Cancer Center /ID# 149782BaltimoreMaryland21229-
Hackensack Univ Med Ctr /ID# 151574HackensackNew Jersey07601-
Utah Cancer Specialists /ID# 151604Salt Lake CityUtah84106-
Cancer Care Northwest /ID# 151605SpokaneWashington99202-
West Virginia Univ School Med /ID# 151602MorgantownWest Virginia26506-

Find similar trials in Louisville, KY

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Norton Cancer Institute· Louisville, KYSt. Agnes Cancer Center· Baltimore, MDHackensack Univ Med Ctr· Hackensack, NJUtah Cancer Specialists· Salt Lake City, UTCancer Care Northwest· Spokane, WAWest Virginia Univ School Med· Morgantown, WV

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