Tag: lymphoma cancer

FDA Approves Ibrutinib for the Treatment of Patients with Waldenstrom’s Macroglobulinemia

Earlier today the FDA announced the expanded approval of ibrutinib in the treatment of patients with Waldenstrom’s Macroglobulinemia. Ibrutinib had previously received a “breakthrough therapy” designation for this use.

“The FDA based its approval of Imbruvica for WM on a clinical study of 63 previously treated participants. All study participants received a daily 420 milligram orally administered dose of the medication until disease progression or side effects became intolerable. Results showed 62 percent of participants had their cancer shrink after treatment (overall response rate). At the time of the study, the duration of response ranged from 2.8 months to approximately 18.8 months.”

This is the fourth lymphoma related indication that ibrutinib has received approval to treat. Previously the drug received approval for the treatment of patients with  mantle cell lymphoma who received one prior therapy, patients with previously treated chronic lymphocytic leukemia (CLL), and treatment of CLL patients who carry a deletion in chromosome 17. Currently, further studies with ibrutinib for patients with Waldenstrom’s are ongoing at Weill Cornell. 

Finally, we would like to recognize all the patients with WM that have participated in these trials at WCMC and elsewhere for making FDA approval of this groundbreaking drug a reality.

New Developments in Lymphoma – Winter 2015 Newsletter

The Lymphoma Program has published the winter 2015 edition of the New Developments in Lymphoma Newsletter.

Please look to this space for further announcements of future newsletter issues, or sign up for advance notice of the newsletter here.

New Clinical Trial: An Open-label, Phase 1 Study of ACP-196 in Patients with Follicular Lymphoma

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with follicular lymphoma (FL). The study sponsor is Acerta Pharma BV, and the principal investigator at Weill Cornell is Dr. Peter Martin. 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 greater than or equal to 18 years of age
  • Confirmed diagnosis of FL Grade 1, 2, or 3a, which has relapsed after, or been refractory to >  or = 1 prior therapy for FL and which requires treatment
  • Detailed eligibility will be reviewed when you contact the study team

Study Details

The purpose of this study is to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and activity of 2 different schedules of ACP-196 administration in subjects with FL.

Clinical Studies have shown that targeting the B-cell receptor (BCR) signaling pathway by inhibiting Bruton tyrosine kinase (Btk) produces significant clinical benefit in patients with non-Hodgkin lymphoma including FL. Ibrutinib, a first generation Btk inhibitor, has been approved for the treatment of chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). In addition, in a first-in-human study of ibrutinib, 6 of 16 subjects (38%) with FL had an objective response.  Acerta Pharma BV has developed a novel second generation Btk inhibitor, ACP-196, that achieves significant oral bioavailability and potency in preclinical models. ACP-196 monotherapy is currently in Phase 1 studies in subjects with CLL and in healthy volunteers.

This study is a multicenter, open-label, randomized, parallel group study. No placebo will be administered during this study. Twenty subjects will be equally randomized (1:1 ratio) into 2 cohorts. In each cohort, subjects will take 200mg of ACP-196 per day, but with different schedules of administration:

  • Cohort 1: ACP-196 100 mg/twice daily for 28 days (= 1 cycle)
  • Cohort 2: ACP-196 200 mg/once daily for 28 days (= 1 cycle)

Treatment with ACP-196 may be continued for more than 28 days until disease progression or an unacceptable drug-related toxicity occurs. Dose modification provisions are provided in the study protocol. All subjects who discontinue study drug will have a safety follow-up visit 30 (+/- 7) days after the last dose of the study drug unless they have started another cancer therapy within that time frame.