New Clinical Trial: A Phase 1 Open Label Study of ACP-196 in Patients with Waldenstrom’s Macroglobulinemia

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with diffuse large B-cell lymphoma. The study sponsor is Acerta Pharma BV, and the principal investigator at Weill Cornell is Dr. Richard Furman. 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 a confirmed diagnosis of Waldenstrom’s Macroglobulinemia
  • Previously treated with at least one prior therapy
  • Cannot have received prior therapy with a BTK inhibitor
  • Must be disease free from a former malignancy for at least two years
  • Detailed eligibility reviewed when you contact the study team. 

Study Details

This clinical trial is for men and woman with a form of cancer called Waldenstrom’s Macroglobulinemia (WM) who have relapsed or not responded to at least one prior therapy. Inhibition of Bruton’s tyrosine kinase (BTK) has been established as an effective means for treating WM.  ACP-196 is an oral, novel inhibitor of BTK with increased specificity for the target and fewer drug interactions than other BTK inhibitors being studied.  Subjects will receive different doses ACP-196 (depending upon when they enter the trial) in order to determine the side effects and effective dose of ACP-196.

Treatment Plans

Subjects will be assigned to one of two treatment groups:

Cohort 1: ACP-196 100 mg twice a day (BID) for 28 days
Cohort 2: ACP-196 200 mg once a day (QD) for 28 days

FDA Approves Bortezomib for Patients with Previously Untreated Mantle Cell Lymphoma

Late last week the FDA announced the approval of bortezomib (VELCADE) for injection for patients with previously untreated mantle cell lymphoma (MCL). This approval was based on results from a head to head Phase III clinical trial. The study found that,

“…previously untreated patients receiving a VELCADE-containing combination (VcR-CAP) experienced a 59 percent relative improvement in the study’s primary endpoint of progression-free survival (PFS) compared to those who were administered the standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) regimen (median 25 vs. 14 months; Hazard Ratio [HR] 0.63; P<0.001) at a median follow up of 40 months. An Independent Review Committee (IRC) assessed the primary efficacy endpoint of PFS. The complete response (CR) rate for patients receiving VcR-CAP vs. R-CHOP was 44 percent vs. 34 percent.”

The full press release can be found here.

The full listing of MCL trials at WCMC is available on the clinical trials website. Look to this space for further news concerning  bortezomib trials for MCL patients at WCMC.

New Developments in Lymphoma– Fall Newsletter

The Lymphoma Program has published the fall 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.