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
This research is investigating a new oral medicine, ABBV-101, for adults with a type of blood cancer called non-Hodgkin's lymphoma (NHL). This includes various NHL subtypes like chronic lymphocytic leukaemia (CLL) and diffuse large B-cell lymphoma (DLBCL). The main goals are to find out how safe the medicine is, how the body processes it, and if it can help improve the disease. Some participants will receive ABBV-101 alone, while others will take it alongside another medicine called venetoclax. The study will involve around 390 adult participants globally, with some receiving increasing doses to find the safest and most effective amount. This is a long-term study, lasting about 100 months, to carefully monitor the medicine's effects.
At a glance
What is this study about?
This study is looking into a new experimental medicine, ABBV-101, for different types of B-cell blood cancers, specifically non-Hodgkin's lymphoma (NHL). NHL is a cancer that starts in certain white blood cells. This research is important because it aims to find new and more effective ways to treat people whose cancer has either returned after previous treatments (relapsed) or hasn't responded to them (refractory).
The main aims of the study are to understand how safe ABBV-101 is, how it moves through your body, and if it shows signs of helping with the cancer. For some types of cancer, participants might receive ABBV-101 by itself, while for other types, it might be given alongside an existing medicine called venetoclax. The study will involve a large number of people with many different types of NHL to get a broad understanding of how the medicine works.
Initially, a small group of participants will receive increasing doses of ABBV-101 to find the highest dose that can be given safely. Following this, more participants will take part to further check the medicine's safety and see how it affects their disease. This careful approach helps researchers learn about the new medicine step-by-step.
Key takeaways
- The study is testing a new oral medicine (ABBV-101) for advanced B-cell blood cancers like NHL.
- It aims to understand safety, how the body handles the medicine, and if it helps treat the cancer.
- Some participants will receive ABBV-101 alone, others will combine it with venetoclax.
- It's for adults whose cancer has returned or didn't respond to previous treatments.
- Participation involves regular hospital visits for assessments and a long study duration (around 8 years).
- It's a Phase 1 study, focusing on finding a safe dose and initial signs of effectiveness.
Who may be eligible?
This study is for adults aged 18 and over who have B-cell blood cancers, specifically certain types of non-Hodgkin's lymphoma, that have returned or not responded to previous treatments. Generally, you would need to have had at least two different types of treatment for your cancer already. This means that standard treatments known to help your condition are no longer an option for you.
More specifically, if you have chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), you might be eligible if you haven't received a specific type of treatment called a BTK inhibitor or degrader, or if you've had a combination of a BTK inhibitor and BCL-2 inhibitor. If you have diffuse large B-cell lymphoma (DLBCL), you might be eligible if your cancer has come back or not responded after treatments like CAR-T cell therapy or a stem cell transplant, or if these treatments aren't suitable for you. All participants must have active disease that needs treatment.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you an adult aged 18 or over?
- Have you been diagnosed with a specific type of Non-Hodgkin's Lymphoma?
- Has your cancer come back or not responded to at least two previous treatments?
- Are there no other standard treatments available that would benefit you at this time?
- Do you have active cancer that needs treatment?
- Are you suitable for oral medication?
What does participation involve?
If you join this study, you will be taking an experimental medicine called ABBV-101 by mouth. The study involves a careful process: initially, some participants will receive increasing doses of ABBV-101 so the doctors can find the safest and most effective amount. Afterwards, other participants will receive this dose, either alone or combined with another oral medicine called venetoclax. You will need to attend regular visits to a hospital or clinic for medical checks, blood tests, and to monitor any side effects. This will happen frequently throughout the study. The total duration of your participation in the study could be quite long, possibly around 100 months (just over 8 years), to thoroughly assess the long-term effects of the treatment.
Potential risks and benefits
Locations (51)
- Arizona Oncology Associates, PC-HOPE /ID# 252351Verified postcodeTempe, United States
- UC Irvine Medical Center /ID# 263020Verified postcodeOrange, United States
- Stanford University - Palo Alto /ID# 249683Verified postcodePalo Alto, United States
- Rocky Mountain Cancer Centers - Lone Tree /ID# 252237Verified postcodeLone Tree, United States
- Northwestern University Feinberg School of Medicine /ID# 249347Verified postcodeChicago, United States
- Beth Israel Deaconess Medical Center /ID# 249302Verified postcodeBoston, United States
- Rutgers Cancer Institute of New Jersey /ID# 249323Verified postcodeNew Brunswick, United States
- New York Oncology Hematology - Albany Cancer Center /ID# 252240Verified postcodeAlbany, United States
- Northwell Health - Monter Cancer Center /ID# 250422Verified postcodeLake Success, United States
- University of Rochester Medical Center /ID# 249324Verified postcodeRochester, United States
- UC Health - Cincinnati /ID# 249299Verified postcodeCincinnati, United States
- Oncology Assoc. of Oregon PC - WVCI and Research Ctr - Springfield /ID# 249309Verified postcodeEugene, United States
Common questions
What is non-Hodgkin's lymphoma (NHL)?
Non-Hodgkin's lymphoma is a type of cancer that starts in white blood cells called lymphocytes, which are part of your immune system. There are many different types of NHL.
What is an investigational drug?
An investigational drug is a medicine that is still being studied and has not yet been approved for general use. It means doctors are trying to find out if it is safe and effective.
Will I receive the new medicine ABBV-101?
Yes, all participants in this study will receive ABBV-101, either on its own or in combination with another medicine called venetoclax.
How long will I be in the study?
The study aims to track participants for approximately 100 months, which is just over 8 years. This lengthy period allows researchers to properly assess the long-term effects of the medicine.
What are 'relapsed or refractory' cancers?
Relapsed means the cancer has come back after treatment. Refractory means the cancer did not respond to previous treatments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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