The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with refractory MCL, who have failed ibrutinib treatment or were unable to tolerate ibrutinib. The study sponsor is the Bayer Corporation, and the principal investigator at Weill Cornell is Peter Martin M.D.. For more information about the study, please call Amelyn Rodgriguez, RN at (212) 746-1362 or e-mail Amelyn at firstname.lastname@example.org.
- Men and women age 18 and older with histologically confirmed MCL.
- Ibrutinib as the last anti-cancer treatment.
- Availability of fresh tumor tissue.
- Detailed eligibility reviewed when you contact the study team.
This clinical trial is for men and women with mantle cell lymphoma (MCL) who were previously treated for this disease and who failed ibrutinib treatment or were unable to tolerate ibrutinib treatment.
While treatment of MCL with ibrutinib has yielded promising efficacy, clinicians and researchers are reporting the development of ibrutinib resistance. Clinically, ibrutinib resistance leaves MCL patients without an established recourse for further treatment. Offering a treatment targeting a different pathway provides an opportunity to fulfill an unmet medical need in this patient population. In addition, some patients are unable to tolerate ibrutinib treatment, leaving them without an established therapeutic option after first-line treatment failure.
This is a single-arm, open-label phase 2a study to evaluate the efficacy and safety of copanlisib monotherapy in patients with MCL, who failed ibrutinib treatment or were unable to tolerate ibrutinib. Patients will receive copanlisib IV infusion at a starting dose of 60 mg as single agent on Days 1, 8 and 15 of each 28-day treatment cycle. Patients will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects. All patients, except for patients who object to follow-up data collection, will be followed for overall survival at least every 3 months during the survival follow-up period until death or until the end of study, whichever occurs first.