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Monoclonal Antibodies

ABBV-101 for Blood Cancers

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

Follicular lymphoma [FL] (grades 1-3b)

Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately two years

Awards & highlights

Study Summary

This trial will assess the safety and efficacy of ABBV-101 in adults with multiple types of non-Hodgkin's lymphoma (NHL). Frequent medical assessments, blood tests, and side effects will be monitored to determine the effects of the treatment.

Who is the study for?

Adults with certain types of blood cancers, including various forms of non-Hodgkin's lymphoma and chronic lymphocytic leukemia that have not responded to previous treatments. Participants should be in a stable health condition with an expected lifespan of at least 12 weeks and must not have active central nervous system disease or uncontrolled infections.Check my eligibility

What is being tested?

The trial is testing ABBV-101, an oral medication for B-cell malignancies. It includes two phases: dose escalation to find the maximum tolerated dose and dose expansion to assess changes in disease activity. The study will last about 60 months and involves regular medical assessments.See study design

What are the potential side effects?

Potential side effects are being evaluated but may include typical reactions associated with cancer therapies such as fatigue, digestive issues, blood disorders, immune system impacts, and possibly others depending on individual responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with follicular lymphoma.

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I am able to get out of my bed or chair and move around.

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My DLBCL has not responded to CAR-T or HCT, or I am not eligible for these treatments.

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I have been diagnosed with marginal zone lymphoma.

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My condition is transformed from a slow-growing to a more aggressive non-Hodgkin's lymphoma.

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I have chronic lymphocytic leukemia.

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I have been diagnosed with small lymphocytic lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately two years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Electrocardiogram (ECG)

Change in Laboratory Parameters

Change in Vital Signs

+1 more

Secondary outcome measures

Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-101

Duration of Response (DOR)

Maximum Observed Serum Concentration (Cmax) of ABBV-101

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Dose Expansion ABBV-101 R/R non-GCB DLBCLExperimental Treatment1 Intervention

Participants with R/R non-germinal center B cell (GCB) diffuse large B-cell lymphoma (DLBCL) will receive ABBV-101 at the dose determined in the dose escalation arm, as part of the approximately 60 month study duration.

Group II: Dose Expansion ABBV-101 R/R Chronic Lymphocytic Lymphoma (CLL)Experimental Treatment1 Intervention

Participants with R/R CLL will receive ABBV-101 at the dose determined in the dose escalation arm, as part of the approximately 60 month study duration.

Group III: Dose Escalation ABBV-101Experimental Treatment1 Intervention

Participants with relapsed or refractory (R/R) Non-Hodgkin's lymphoma (NHL) will receive escalating doses of ABBV-101, until the maximum administered dose (MAD)/Maximum tolerated dose (MTD) is determined, as part of the approximately 60 month study duration.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

958 Previous Clinical Trials

502,262 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

397 Previous Clinical Trials

146,981 Total Patients Enrolled

Media Library

ABBV-101 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05753501 — Phase 1

Blood Cancers Research Study Groups: Dose Expansion ABBV-101 R/R Chronic Lymphocytic Lymphoma (CLL), Dose Escalation ABBV-101, Dose Expansion ABBV-101 R/R non-GCB DLBCL

Blood Cancers Clinical Trial 2023: ABBV-101 Highlights & Side Effects. Trial Name: NCT05753501 — Phase 1

ABBV-101 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05753501 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for enrolment in this research project?

"As indicated by clinicaltrials.gov, the posting for this trial has not been updated since February 22nd 2023 and is thus no longer actively seeking applicants. Nevertheless, there are currently 278 other trials that require participants to enroll in their programs."

Answered by AI

Has the FDA sanctioned Dose Escalation ABBV-101?

"Our in-house assessment concluded that Dose Escalation ABBV-101 has a safety rating of 1, which is the lowest possible score due to this being an early phase trial with limited data on its efficacy and risk."

Answered by AI

What objectives is this research project attempting to fulfill?

"The two-year long clinical trial aims to observe alterations in laboratory parameters, while also assessing Time to Cmax (Tmax) of ABBV-101, Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-101., and Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria."

Answered by AI

How many medical institutions are participating in this experimental trial?

"Prospective participants in this trial can enrol at New york Oncology Hematology - Albany Cancer Center /ID#252240 located in Albany, NY as well as Northwell Health - Monter Cancer Center/ ID#250422 situated in Lake Success, PA and University of Rochester Cancer Centre /ID#249324 based out of Rochester TX. In total, 8 other sites are available for recruitment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies

2023. "Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05753501.