A Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Combination With Bendamustine/Rituximab (BR) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma

Part of paid clinical trials in La Jolla, California.

Sponsor
AbbVie
Study ID
NCT01594229
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • ABT-199 — DRUG
    ABT-199 is taken orally once daily for 3 days out of each 28 day cycle. This is a dose escalation study, therefore the dose of ABT-199 will change throughout the study.
  • Rituximab — DRUG
    Rituximab will be given by intravenous infusion for 1 day out of each 28 day cycle.
  • Bendamustine — DRUG
    Bendamustine will be given by intravenous infusion for 2 days out of each 28 day cycle.

Study Details

This is a Phase 1, open-label, multicenter study evaluating the safety, pharmacokinetic profile, and preliminary efficacy of ABT-199 in combination with Bendamustine/Rituximab in approximately 60 subjects with relapsed or refractory non-Hodgkin's lymphoma. This study will evaluate the safety and pharmacokinetic profile of ABT-199 in approximately 60 subjects when administered in combination with Bendamustine/Rituximab following a dose escalation scheme, with the objective of defining the dose limiting toxicity and the maximum tolerated dose.

Key Dates

Start date
May 21, 2012
Status verified
Jul 2021
Primary completion
Jul 14, 2020
Completion
Jul 14, 2020

Study Design

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

Arms

  • Experimental: Arm 1
    Non-Hodgkin's Lymphoma (NHL)

Primary Outcome Measure

Determination of the maximum tolerated dose of ABT-199 when administered with Bendamustine and Rituximab in subjects with relapsed or refractory non-Hodgkin's lymphoma [ Time Frame: 3 days of study drug administration within the 28-day cycle at the designated cohort dose ]

Locations (8)

FacilityCityStateZIPSite coordinators
Ucsd /Id# 67350La JollaCalifornia92093-
University of California, Los Angeles /ID# 67343Los AngelesCalifornia90095-
Emory University Hospital /ID# 67349AtlantaGeorgia30322-
Georgia Regents University /ID# 67342AugustaGeorgia30912-
Ingalls Memorial Hosp /ID# 67344HarveyIllinois60426-
Johns Hopkins University /ID# 67345BaltimoreMaryland21287-
Henry Ford Health System /ID# 67346DetroitMichigan48202-
University of Texas MD Anderson Cancer Center /ID# 69222HoustonTexas77030-

Find similar trials in La Jolla, CA

By research site
Ucsd· La Jolla, CAUniversity of California, Los Angeles· Los Angeles, CAEmory University Hospital· Atlanta, GAGeorgia Regents University· Augusta, GAIngalls Memorial Hosp· Harvey, ILJohns Hopkins University· Baltimore, MD

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