ABT-263 + Rituximab for Blood Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a combination of two drugs, ABT-263 (a new potential drug) and rituximab, is safe for individuals with certain blood cancers known as CD20-positive lymphoproliferative disorders. The study aims to understand how these drugs work together and their effects over time. It seeks participants diagnosed with one of these blood disorders who have at least one measurable tumor. Those with a history of blood cancer fitting this description and who can manage daily activities independently may find this trial suitable. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new potential drug.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications before starting, such as steroids for cancer treatment, aspirin, CYP3A inhibitors, and any anti-cancer therapy. If you're on these, you'll need to stop them at least 7 to 14 days before the trial begins.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
In a previous study, ABT-263, also known as Navitoclax, was tested with rituximab to assess its safety for people with certain blood cancers. Research has shown that ABT-263 can effectively target and kill cancer cells in lab tests. However, this study is in an early phase, so researchers are still determining the right dose and monitoring for any side effects.
Rituximab is already used for certain blood cancers, providing more information about its safety. While early studies suggest that ABT-263 can work well with rituximab, some side effects may still occur. Participants in these early studies have reported various experiences, but specific safety data is still being collected.
Since this is an early phase study, the main goal is to monitor participants closely for any adverse effects. It's important to remember that researchers are still learning about the treatment's safety, and more data is needed to fully understand its impact on human health.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for blood cancers, which typically include chemotherapy and monoclonal antibodies, ABT-263 offers a unique approach by targeting and inhibiting proteins that prevent cancer cell death. This mechanism, known as Bcl-2 family inhibition, encourages the cancer cells to undergo apoptosis, or programmed cell death, which could make it more effective in shrinking tumors. Researchers are excited about ABT-263, especially when combined with Rituximab, because this combination has the potential to enhance the effectiveness of standard treatments and possibly work against resistant cancer cells.
What evidence suggests that ABT-263 + rituximab could be effective for blood cancers?
Research has shown that combining ABT-263 with rituximab may effectively treat certain blood cancers. In this trial, participants will receive both ABT-263 and rituximab. ABT-263 targets proteins that help cancer cells survive, aiding in their destruction. Early studies found that combining ABT-263 with rituximab reduces cancer cell growth more effectively than rituximab alone. Rituximab, a well-known treatment for some blood cancers, targets and destroys cancerous B cells. Together, these treatments aim to kill cancer cells more effectively than either one alone. While detailed results from human trials are still being gathered, these early findings are promising for this treatment approach.26789
Who Is on the Research Team?
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ABT-263 in combination with rituximab to evaluate safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants may continue to receive ABT-263 for up to 14 years with quarterly evaluations
What Are the Treatments Tested in This Trial?
Interventions
- ABT-263
- Rituximab
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie (prior sponsor, Abbott)
Lead Sponsor
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
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
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