New Clinical Trial: A Phase 2 Study to Evaluate the Efficacy & Safety of Copanlisib in Patients with Relapsed/Refractory MCL, who Failed Ibrutinib Treatment or Were Unable to Tolerate Ibrutinib

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 amr2017@med.cornell.edu.

Key Eligibility

  • 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.

Study Summary 

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.

 

Author: lymphomaprogram

Located on the Upper East Side of New York City, the Lymphoma Program at Weill Cornell Medical College/NewYork Presbyterian Hospital is internationally recognized for our efforts to enable patients with non-Hodgkin lymphoma, Hodgkin disease and related disorders to have the best possible clinical outcome, including cure when possible.

Post a Comment

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s