Clinical trial for Imbruvica/Ibrutinib , Gazyva/Obinutuzumab +/- Venclexta/Venetoclax at 97 sites USA

[lankisterguy]

A Randomized Phase III Study of the Addition of Venetoclax to Ibrutinib and Obinutuzumab Versus Ibrutinib and Obinutuzumab in Untreated Younger Patients With Chronic Lymphocytic Leukemia (CLL)

clinicaltrials.gov/ct2/show...

Per Dr. Furman: "This is a large, cooperative group study. It will be at many more than those listed. We will have this at Weill Cornell as well."

This phase III trial studies how well ibrutinib and obinutuzumab with or without venetoclax work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib, obinutuzumab and venetoclax may work better in treating patients with chronic lymphocytic leukemia.

Study Type :Interventional (Clinical Trial)

Estimated Enrollment :720 participants

Allocation:Randomized

Intervention Model:Parallel Assignment

Masking:None (Open Label)

Show 97 locations: clinicaltrials.gov/ct2/show...

Len

[cajunjeff]

Ibrutinib, venetoclax and gazyva are probably the three most exciting new drugs from this past decade used to treat Cll. Combination studies using any of the three together thus far appears to suggest these drugs may have synergistic effect when used together. Using all three together could be the dream team treatment for Cll, if I can steal an old basketball Olympic team analogy.

The size of this study, both in terms of the number of patients involved and the geography, is a pretty good indication that a lot of Cll doctors think this is the combo, once they learn the optimum dose and sequence, that will replace FCR as the gold standard. I expect (hope) this combo will produce a higher percentage of cures than fcr, with less toxicity and with efficacy over a larger patient profile.

I use the word “cure” with the assumption, which I think is fair, that those who have 15 yr plus remissions on fcr are mostly cured. That group that is cured with fcr is mostly mutated IGHV Cll with no other bad mutations. I think we might see long fcr type remissions with ibrutinib, venetoclax and gazyva with some of both mutated and unmutated cll.

[thompsonellen]

As a person who benefited from the single site O+I+V trial at OSU, I'm thrilled that access to these drugs is going to be available more broadly and more people won't have to travel like I did. I thought it was interesting that all of the centers in my state are in really small markets.