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Monoclonal Antibodies
ABBV-319 for Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia
Phase 1
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called ABBV-319 for adults with certain blood cancers that have come back or didn't respond to treatment. The drug is given in regular intervals, starting with small amounts and gradually increasing to find the most effective amount. The goal is to see if ABBV-319 is safe and effective in reducing cancer activity.
Who is the study for?
Adults with certain types of blood cancers (DLBCL, FL, or CLL) that have come back or didn't respond to treatment can join. They must be in good physical condition (ECOG 0-1), meet specific lab value criteria, and have measurable disease. Those who've had CD19-targeting therapy need a recent biopsy. People with active infections, uncontrolled conditions, or CNS lymphoma cannot participate.
What is being tested?
The trial is testing ABBV-319's safety and how it affects the body when given through an IV to adults with relapsed/refractory B-cell lymphomas. It includes two phases: finding the best dose and then seeing how well it works at that dose across multiple sites worldwide.
What are the potential side effects?
Potential side effects are not specified but will be monitored throughout the study via medical assessments and blood tests. Side effects could include typical reactions to cancer treatments such as fatigue, nausea, infusion-related reactions, and changes in blood counts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Antidrug Antibody (ADA)
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-319
Maximum Observed Serum Concentration (Cmax) of ABBV-319
+4 moreSecondary study objectives
Duration of Response (DOR)
Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria
Overall survival (OS) Time
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Dose Escalation ABBV-319Experimental Treatment1 Intervention
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 recommended Phase 2 dose (RP2D) is determined.
Group II: (ABBV-319) Follicular Lymphoma (FL) ParticipantsExperimental Treatment1 Intervention
Participants with R/R FL will receive ABBV-319 in 21-day cycles.
Group III: (ABBV-319) Diffuse Large B-cell Lymphoma (DLBCL) ParticipantsExperimental Treatment1 Intervention
Participants with R/R DLBCL will receive ABBV-319 in 21-day cycles.
Group IV: (ABBV-319) Chronic Lymphocytic Leukemia (CLL) ParticipantsExperimental Treatment1 Intervention
Participants with R/R CLL will receive ABBV-319 in 21-day cycles.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Follicular Lymphoma include monoclonal antibodies like rituximab, which target the CD20 protein on B-cells, and small molecule inhibitors such as ibrutinib and venetoclax, which interfere with B-cell receptor signaling and BCL2 pathways, respectively. These treatments work by specifically targeting cancerous B-cells, thereby reducing tumor burden and improving patient outcomes.
Investigational drugs like ABBV-319, which are being studied for relapsed or refractory B-cell lymphomas, aim to enhance these targeted approaches, offering hope for more effective management of the disease.
Treatment patterns and outcomes of patients with relapsed or refractory follicular lymphoma receiving three or more lines of systemic therapy (LEO CReWE): a multicentre cohort study.Treatment of indolent lymphoma.Zevalin: the first radioimmunotherapy approved for the treatment of lymphoma.
Treatment patterns and outcomes of patients with relapsed or refractory follicular lymphoma receiving three or more lines of systemic therapy (LEO CReWE): a multicentre cohort study.Treatment of indolent lymphoma.Zevalin: the first radioimmunotherapy approved for the treatment of lymphoma.
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
1,037 Previous Clinical Trials
522,860 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
458 Previous Clinical Trials
163,614 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any active infections or uncontrolled health conditions.I have a B-cell cancer diagnosis needing treatment, as per WHO standards.I have an active brain disease or primary brain lymphoma.I am fully active or can carry out light work.I have had a biopsy after my last CD19-targeting therapy.I have DLBCL, FL, or CLL needing treatment, as confirmed by a doctor.
Research Study Groups:
This trial has the following groups:- Group 1: (ABBV-319) Diffuse Large B-cell Lymphoma (DLBCL) Participants
- Group 2: Dose Escalation ABBV-319
- Group 3: (ABBV-319) Follicular Lymphoma (FL) Participants
- Group 4: (ABBV-319) Chronic Lymphocytic Leukemia (CLL) Participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.