A Phase 1b Study Evaluating the Safety and Tolerability of ABT-199 in Combination With Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Part of paid clinical trials in La Jolla, California.

Sponsor
AbbVie
Study ID
NCT01682616
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 continuously once daily. 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 on day 1 of Months 1, 2, 3, 4, 5, and 6. May be reinitiated for an additional 6 months.

Study Details

This is a Phase 1b, open-label, multicenter study evaluating the safety and tolerability of ABT-199 in combination with rituximab in up to 50 subjects with Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. The primary objectives of this study are to assess the safety profile, to determine the maximum tolerated dose and establish the Recommended Phase Two Dose of ABT-199 when administered in combination with rituximab. The dose escalation portion of the study will include approximately 30 subjects. Once the recommended phase two dose and schedule have been determined, up to 20 additional subjects will be enrolled in an expanded safety portion of the study. Subjects who meet criteria for CR, CRi, or MRD-negative PR during the study may discontinue ABT 199. If disease progression occurs, as defined by iwCLL NCI/WG criteria for tumor response, or MRD progression, subjects may re-initiate ABT-199.

Key Dates

Start date
Jul 25, 2012
Status verified
Jun 2023
Primary completion
Jun 23, 2022
Completion
Jun 23, 2022

Study Design

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

Arms

  • Experimental: Arm 1
    Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)

Primary Outcome Measure

Assess the safety profile, to determine the maximum tolerated dose and Recommended Phase Two Dose of ABT-199 when administered in combination with rituximab (R) in subjects with relapsed chronic lymphocytic leukemia and small lymphocytic lymphoma. [ Time Frame: Continuous dosing at designated dose level up to Month 6. At end of combination treatment, ABT-199 monotherapy may continue up to 8 years following the date of the last subject enrolled. If disease progression occurs, subjects may re-initiate ABT-199. ]

Locations (4)

FacilityCityStateZIPSite coordinators
Moores Cancer Center at UC San Diego /ID# 70398La JollaCalifornia92093-
Northwestern University Feinberg School of Medicine /ID# 71593ChicagoIllinois60611-2927-
North Shore University Hospital /ID# 71813New Hyde ParkNew York11040-
Duke Cancer Center /ID# 71393DurhamNorth Carolina27710-3000-

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, CANorthwestern University Feinberg School of Medicine· Chicago, ILNorth Shore University Hospital· New Hyde Park, NYDuke Cancer Center· Durham, NC

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