ABT-263 + Rituximab for Blood Cancers

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie (prior sponsor, Abbott)

Must not be taking: Steroids, Aspirin, CYP3A inhibitors

Disqualifiers: CNS disease, Significant infections, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

29 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 1 study evaluating the safety of ABT-263 administered in combination with rituximab in participants with CD20-positive lymphoproliferative disorders. The extension portion of the study will allow active participants to continue to receive ABT-263 for up to 14 years after the last participant transitions with quarterly study evaluations.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for adults with certain types of lymphoid cancers, like non-Hodgkin's lymphoma or chronic lymphocytic leukemia. They should be relatively healthy (ECOG score <=1), have good kidney, liver, and blood clotting function, and not be pregnant or breastfeeding. Participants need measurable disease and can't join if they've had recent significant bleeding issues, other cancers in the last 5 years (with some exceptions), severe allergies to monoclonal antibodies, major organ diseases, or active infections.

Inclusion Criteria

I have a CD20-positive lymphoma with a measurable lesion.

My blood counts meet the required levels for treatment.

I am not pregnant, and if capable of becoming pregnant, I am using effective birth control.

Exclusion Criteria

I do not have any uncontrolled conditions like a serious fungal infection or recent fever with low white blood cells.

I have tested positive for HIV, Hepatitis B, or Hepatitis C, but can join if I'm only a carrier of Hepatitis B.

I have a bleeding condition or have had significant bleeding in the past 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ABT-263 in combination with rituximab to evaluate safety

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue to receive ABT-263 for up to 14 years with quarterly evaluations

Treatment Details

Interventions

• ABT-263
• Rituximab

Trial Overview The study tests ABT-263 combined with rituximab against various lymphoid cancers over a long period (up to 13 years). It's an early-phase trial focused on safety where participants will receive the treatment combination and undergo regular health checks every three months to monitor effects.

Participant Groups

Group I: ABT-263 + rituximab Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

AbbVie (prior sponsor, Abbott)

Lead Sponsor

Trials

231

Recruited

149,000+

Dr. Roopal Thakkar

AbbVie (prior sponsor, Abbott)

Chief Medical Officer since 2023

MD, Wayne State University School of Medicine; Bachelor's in Cellular and Molecular Biology, University of Michigan

Robert A. Michael

AbbVie (prior sponsor, Abbott)

Chief Executive Officer

Bachelor's degree in Finance, University of Illinois

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD