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

AbbVie127 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

127

Conditions

Chronic Lymphocytic Leukemia

Interventions

VenetoclaxDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participant must have a diagnosis of chronic lymphocytic leukemia (CLL) that meets 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (IWCLL NCI-WG) criteria * Participant has relapsed/refractory disease with an indication for treatment * Participant has refractory disease or developed recurrence after therapy with a B-cell receptor pathway inhibitor (BCR PI) * Participant must have an Eastern Cooperative Oncology Group performance score of ≤ 2 * Participant must have adequate bone marrow function at Screening * Participant must have adequate coagulation profile, renal, and hepatic function, per laboratory reference range at Screening Exclusion Criteria: * Participant has undergone an allogeneic stem cell transplant within the past year * Participant has developed Richter's transformation confirmed by biopsy * Participant has active and uncontrolled autoimmune cytopenia * Participant has malabsorption syndrome or other condition that precludes enteral route of administration * Participant is human immunodeficiency virus (HIV) positive or has chronic hepatitis B or hepatitis C virus requiring treatment * Participant has known contraindication or allergy to both xanthine oxidase inhibitors and rasburicase

Locations (15)

Moores Cancer Center at UC San Diego /ID# 128535

La Jolla, California, United States

University of California, Los Angeles /ID# 127262

Los Angeles, California, United States

Outcomes

Primary Outcomes

Overall Response Rate (ORR)

Overall response rate is defined as the percentage of participants with an overall response (per the investigator assessment) 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL) National Cancer Institute-Working Group (NCI-WG) criteria.

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

Secondary Outcomes

Duration of Response (DOR)

DOR is defined as the number of days from the date of first response (complete response \[CR\], complete response with incomplete marrow recovery \[CRi\], nodular partial remission \[nPR\], or partial remission \[PR\]) to the earliest recurrence or progressive disease. DOR was analyzed by Kaplan-Meier (K-M) methodology.

Time to Progression (TTP)

TTP is defined as the number of days from the date of first dose to the date of earliest disease progression (PD). TTP was analyzed by Kaplan-Meier (K-M) methodology.

Progression-free Survival (PFS)

PFS is defined as the number of days from the date of first dose to the date of earliest disease progression (PD) or death. PFS was analyzed by Kaplan-Meier methodology.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.