Tag: Waldenstrom’s Macroglobulinemia

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

Ibrutinib Granted Breakthrough Status by FDA for Two B-Cell Malignancies

On February 12, the FDA granted a Breakthrough Therapy Designation for the investigational agent ibrutinib in the treatment of mantle cell lymphoma and Waldenstrom’s macroglobulinemia. This designation is awarded to drugs whose preliminary clinical evidence suggests an improvement over existing therapies on one or more clinically significant endpoints. Enacted as part of the 2012 FDA Safety and Innovation Act, the Breakthrough Therapy Designations were conceived to help speed along the drug development process, drastically decreasing the time between clinical trials and final regulatory approval.

Ibrutinib, an oral drug designed to specifically target an enzyme called Bruton’s tyrosine kinase (BTK), has demonstrated promising activity in multiple phase 1 and 2 clinical trials performed at Weill Cornell Medical College and around the world. As one of the leading institutions in the study of ibrutinib since its first trials 3 years ago, Weill Cornell is uniquely positioned in its experience with ibrutinib.

Currently, there are ongoing ibrutinib clinical trials at the Weill Cornell Lymphoma Center open to patients with CLL and mantle cell lymphoma. Please stay updated with our clinical trials listing for forthcoming trials with ibrutinib.

Waldenstrom’s Macroglobulinemia Clinical Database Study

The purpose of this study at Weill Cornell Medical College is to learn about what might cause lymphoma, to learn about how lymphoma harms the body, and to learn about treatments for Waldenstrom’s Macroglobulinemia.

This study is open to people being treated for Waldenstrom’s Macroglobulinemia outside of NewYork-Presbyterian/Weill Cornell, but participation would require at least one visit at Weill Cornell.

Waldenstrom’s Macroglobulinemia is a rare type of lymphoma, a disease where one of the white blood cells, the lymphocytes, increases in number more than they should. The lymphocytes in Waldenstrom’s Macroglobulinemia also secrete a protein called IgM. Excess IgM can interfere with the circulation of blood. Investigators at Weill Cornell Medical College and other institutions are collecting information about lymphoma patients and their disease, as well studying their lymphoma cells in the laboratory.

Participants in this study give their permission for the investigators to collect their clinical information for research purposes. In addition, the researchers will store participants’ blood, urine, check swab, bone marrow and/or tumor tissue samples for research studies to be performed now and in the future. In some cases, participants may be asked by their physician to provide additional samples.

By studying the clinical course of lymphoma patients and the lymphoma cells in the laboratory, we hope to learn more about what causes lymphoma. We also hope that information from these studies will help identify new treatments for people with lymphoma.

To find out more about this study please contact June Greenberg, RN at (212) 746-2651 or email June at jdg2002@med.cornell.edu.

The principal investigator of this study is Dr. Peter Martin. Click here to read Dr. Martin’s clinical and research profile.