RECRUITING

A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-319 in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL), R/R follicular lymphoma (FL), or R/R CLL. Adverse events will be assessed. ABBV-319 is an investigational drug being developed for the treatment of R/R DLBCL, R/R FL, or R/R CLL. This study will include a dose escalation phase to determine the doses of ABBV-319 that will be used in the next phase and a dose expansion phase to determine the change in disease activity in participants with R/R DLBCL, R/R FL, and R/R CLL. Approximately 154 adult participants with R/R B cell lymphomas including R/R DLBCL, R/R FL, and R/R CLL will be enrolled in the study in sites world wide. In the Dose Escalation phase of the study participants will receive escalating intravenously infused doses of ABBV-319 in 21-day cycles, until the Phase 2 dose is determined. In the dose expansion phase of the study participants receive intravenously infused ABBV-319 in 21-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Official Title

A First In Human Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell Malignancies

Quick Facts

Study Start:2023-04-26
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05512390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * For dose escalation (Part 1) only: Participants with documented diagnosis of B-cell malignancies including those with histology based on criteria established by the World Health Organization (WHO), and measurable disease requiring treatment, as per the protocol.
  2. * For the relapsed or refractory diffuse large b-cell lymphoma (DLBCL), follicular lymphoma (FL), and Chronic lymphocytic leukemia (CLL) dose expansion cohorts (Part 2) only: Participants with documented diagnosis of one of the B-cell malignancies noted in the protocol with histology based on criteria established by the WHO, and measurable disease requiring treatment, as per the protocol.
  3. * Laboratory values meeting the criteria noted in the protocol.
  4. * For participants previously treated with a CD19-targeting therapy (eg, CD19 monoclonal antibody) a core or excision tumor biopsy subsequent to the most recent CD19-targeting therapy must be collected.
  5. * Participant must have measurable disease, as defined by the 2014 Lugano Classification.
  1. * Known active central nervous system (CNS) disease, or primary CNS lymphoma.
  2. * Known active infection or clinically significant uncontrolled conditions as per the protocol.
  3. * Eastern Cooperative Oncology Group (ECOG) performance status \>= 2.

Contacts and Locations

Study Contact

ABBVIE CALL CENTER
CONTACT
844-663-3742
abbvieclinicaltrials@abbvie.com

Principal Investigator

ABBVIE INC.
STUDY_DIRECTOR
AbbVie

Study Locations (Sites)

University of Arizona Cancer Center - Tucson /ID# 247752
Tucson, Arizona, 85724
United States
Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232
Miami, Florida, 33136
United States
Allina Health System /ID# 251782
Minneapolis, Minnesota, 55407-1321
United States
University of Nebraska Medical Center /ID# 246715
Omaha, Nebraska, 68198
United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246
New York, New York, 10065-6007
United States
Novant Health Presbyterian Medical Center /ID# 246719
Charlotte, North Carolina, 28204
United States
Baylor Sammons Cancer Center /ID# 247715
Dallas, Texas, 75246
United States
University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: AbbVie

  • ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-26
Study Completion Date2027-02

Study Record Updates

Study Start Date2023-04-26
Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

  • Diffuse Large B-Cell Lymphoma
  • Chronic Lymphocytic Leukemia
  • Follicular Lymphoma
  • Cancer
  • B-Cell Malignancies
  • ABBV-319

Additional Relevant MeSH Terms

  • Diffuse Large B-Cell Lymphoma
  • Chronic Lymphocytic Leukemia
  • Follicular Lymphoma