A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia (CLL) Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy

Part of paid clinical trials in La Jolla, California.

Sponsor
AbbVie
Study ID
NCT02141282
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Venetoclax — DRUG
    Each dose of venetoclax was to be taken with approximately 240 mL of water within 30 minutes after the completion of breakfast or the participant's first meal of the day.

Study Details

This was an open-label, non-randomized, multicenter, Phase 2 study evaluating the efficacy and safety of ABT-199 in 127 participants with relapsed or refractory chronic lymphocytic leukemia (CLL) after B-cell receptor signaling pathway inhibitors (BCR PI) treatment.

Key Dates

Start date
Sep 10, 2014
Status verified
Nov 2022
Primary completion
Dec 22, 2021
Completion
Dec 22, 2021

Study Design

Enrollment
127 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ABT-199 after ibrutinib therapy
    Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 593 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
  • Experimental: ABT-199 after idelalisib therapy
    Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 1023 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
  • Experimental: ABT-199 after ibrutinib therapy: Expansion Cohort
    Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 622 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants enrolled into the Expansion Cohort with bulky disease at study entry who were non-responders or those who showed signs of clinical progression after completing the ramp up to 400 mg either by clinical disease assessment or by CT/MRI scan between Week 6 to Week 12 may have been permitted to escalate venetoclax to a daily dose of 600 mg.
  • Experimental: ABT-199 after idelalisib therapy: Expansion Cohort
    Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 1189 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants enrolled into the Expansion Cohort with bulky disease at study entry who were non-responders or those who showed signs of clinical progression after completing the ramp up to 400 mg either by clinical disease assessment or by CT/MRI scan between Week 6 to Week 12 may have been permitted to escalate venetoclax to a daily dose of 600 mg.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: At Wk 5, Day 1; Wk 8, Day 1; Wk 12, Day 1; Wk 16, Day 1; Wk 20, Day 1; Wk 24, Day 1; Wk 36, Day 1; every 12 wks after Wk 36; Final Visit; estimated median time on follow-up was 1694 d for ibrutinib failure cohort and 1942 d for idelalisib failure cohort ]

Locations (15)

FacilityCityStateZIPSite coordinators
Moores Cancer Center at UC San Diego /ID# 128535La JollaCalifornia92093-
University of California, Los Angeles /ID# 127262Los AngelesCalifornia90095-
Stanford University School of Med /ID# 126495StanfordCalifornia94305-2200-
Georgetown University Hospital /ID# 127261Washington D.C.District of Columbia20007-
Emory Midtown Infectious Disease Clinic /ID# 131249AtlantaGeorgia30322-
Northwestern University Feinberg School of Medicine /ID# 126497ChicagoIllinois60611-2927-
Beth Israel Deaconess Medical Center /ID# 134509BostonMassachusetts02215-5400-
Dana-Farber Cancer Institute /ID# 126496BostonMassachusetts02215-
Columbia Univ Medical Center /ID# 128536New YorkNew York10032-3725-
New York Presbyterian Hospital Weill Cornell Medical Center /ID# 129648New YorkNew York10032-3725-
Univ Rochester Med Ctr /ID# 130011RochesterNew York14642-
The Ohio State University /ID# 127263ColumbusOhio43210-
University of Pennsylvania /ID# 126860PhiladelphiaPennsylvania19104-5502-
University of Texas MD Anderson Cancer Center /ID# 126498HoustonTexas77030-
University of Utah /ID# 130813Salt Lake CityUtah84112-5500-

Find similar trials in La Jolla, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Moores Cancer Center at UC San Diego· La Jolla, CAUniversity of California, Los Angeles· Los Angeles, CAStanford University School of Med· Stanford, CAGeorgetown University Hospital· Washington D.C., DCEmory Midtown Infectious Disease Clinic· Atlanta, GANorthwestern University Feinberg School of Medicine· Chicago, IL

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