FDA Grants Special Protocol Assessment to Phase III Ublituximab/Ibrutinib Study

FDA Grants Special Protocol Assessment to Phase III Ublituximab/Ibrutinib Study

"TG Therapeutics has reached an agreement with the FDA regarding a Special Protocol Assessment for a phase III clinical trial exploring ublituximab (TG-1101, a chimeric recombinant glycoengineered monoclonal antibody directed against CD20) in combination with ibrutinib (Imbruvica) for the treatment of patients with chronic lymphocytic leukemia (CLL), the company announced last week."



"The randomized controlled trial is planned to enroll approximately 330 patients, who will receive ublituximab plus ibrutinib or ibrutinib alone. "

More: onclive.com/web-exclusives/...

Watch out for more combination therapies with ibrutinib and Idelalisib.


Photo: Kookaburras in an old gum tree. The one on the left is about to enjoy a skink for lunch. The skink has dropped its tail as a diversionary tactic and which it can regrow. The tail wriggles and twists to attract the predator, but this time that ploy didn't work :( .

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5 Replies

  • AussieNeil, I'm always grateful to read your posts. I trully enjoy the pics.

    Question - trial - available in Australia ?

  • I make it a practice to check these sites for any promising trials in Australia prior to my haematology appointments. The CLL trials listed on the sites don't always match:

    Current Leukaemia, Lymphoma and Myeloma clinical trials


    List of all cancer trials in Australia



  • > Question - trial - available in Australia ?

    US only and right now on a very small scale.

    They have a larger Phase 1/2 going on a MD Anderson combining Ublituximab, which is a souped up Rituxan, with their TGR-1202 which is a PI3k-delta inhibitor. My doc is involved in that. They are also trying to kick off a study of a 3-component cocktail Ublituximab plus Ibrutinib plus TGR-1202 which might be *very*interesting!

    Ublituximab is rather novel. They take a normal Rituxan-like anti-CD20 monoclonal antibody and shroud all of it with tailored sugar molecules leaving *only* the receptor mating site exposed. It will supposedly cut down on undesired side effects of administration.

  • Thank you so much for replies. So valuable to have this site, so grateful.

  • Ublituximab Is Combined With Ibrutinib in High-Risk CLL Study

    "The open-label GENUINE study, currently accruing patients at the Willamette Valley Cancer Institute and 150 other locations throughout the United States, is evaluating whether the addition of ublituximab to ibrutinib improves outcomes for patients with relapsed or refractory high-risk CLL whose disease exhibits at least one of the three high-risk cytogenetic features that Sharman described.

    Patients who exhibit these high-risk markers tend to progress at a faster rate than patients without those features, said Sharman. “The median progression-free survival [PFS] in those with the 17p deletion is about 2 years. We’re trying to see if we can improve that with the addition of the CD20 antibody,” he said."



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