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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
Study Summary
This trial will assess the safety and preliminary efficacy of ABBV-319, an investigational drug, in patients with relapsed or refractory diffuse large B-cell lymphoma, follicular lymphoma, or chronic lymphocytic leukemia.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Duration of Response (DOR)
Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria
Overall survival (OS) Time
+2 moreTrial 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.
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Who is running the clinical trial?
AbbVieLead Sponsor
958 Previous Clinical Trials
502,270 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,984 Total Patients Enrolled
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the basic goal of this experiment?
"According to the clinical trial sponsor AbbVie, this study will assess Time to Cmax (Tmax) of ABBV-319 as its primary outcome over a 6 month period. In addition, secondary outcomes such as Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria, Time to Response and Duration of Response (DOR), are being tracked."
Answered by AI
Does this trial currently have vacancies for participants?
"Contrary to initial expectation, clinicaltrials.gov has verified that this trial is not actively recruiting patients; the study was initially published on August 27th 2022 and had its last update on August 22nd 2022. However, numerous other trials are currently enrolling participants (2918 in total)."
Answered by AI
What are the perceived risks associated with ABBV-319 usage?
"Due to the limited data confirming ABBV-319's efficacy and safety, our team at Power assigned a score of 1 in this regard."
Answered by AI
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