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)

Part of paid clinical trials in Tucson, Arizona.

Sponsor
AbbVie
Study ID
NCT05512390
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ABBV-319 — DRUG
    Intravenous (IV); Infusion

Study Details

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.

Key Dates

Start date
Apr 26, 2023
Status verified
Jan 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
154 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation ABBV-319
    Participants with relapsed or refractory (R/R) B cell lymphomas including diffuse large b-cell lymphoma (DLBCL) or follicular lymphoma (FL), and Chronic lymphocytic leukemia (CLL) will receive escalating doses of ABBV-319 in 21-day cycles, until the doses of ABBV-319 that will be used in the next phase are determined.
  • Experimental: (ABBV-319) Diffuse Large B-cell Lymphoma (DLBCL) Participants
    Participants with R/R DLBCL will receive ABBV-319 in 21-day cycles.
  • Experimental: (ABBV-319) Follicular Lymphoma (FL) Participants
    Participants with R/R FL will receive ABBV-319 in 21-day cycles.
  • Experimental: (ABBV-319) Chronic Lymphocytic Leukemia (CLL) Participants
    Participants with R/R CLL will receive ABBV-319 in 21-day cycles.

Primary Outcome Measure

Number of Dose-Limiting Toxicities (DLT) [ Time Frame: Day 42 ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer Center - Tucson /ID# 247752TucsonArizona85724-
Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232MiamiFlorida33136-
Allina Health System /ID# 251782MinneapolisMinnesota55407-1321-
University of Nebraska Medical Center /ID# 246715OmahaNebraska68198-
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246New YorkNew York10065-6007-
Novant Health Presbyterian Medical Center /ID# 246719CharlotteNorth Carolina28204-
Baylor Sammons Cancer Center /ID# 247715DallasTexas75246-
University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234San AntonioTexas78229-

Find similar trials in Tucson, AZ

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By specialty
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By research site
University of Arizona Cancer Center - Tucson· Tucson, AZSylvester Comprehensive Cancer Center - University of Miami· Miami, FLAllina Health System· Minneapolis, MNUniversity of Nebraska Medical Center· Omaha, NEMemorial Sloan Kettering Cancer Center-Koch Center· New York, NYNovant Health Presbyterian Medical Center· Charlotte, NC

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