New Clinical Trial: A Phase 1/2 Proof of Concept Study of the Combination of ACP-196 & ACP-319 in Subjects with B-cell Malignancies

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with previously treated B-cell malignancies. The study sponsor is Acerta Pharmaceuticals, and the principal investigator at Weill Cornell is Richard Furman 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.
  • Diagnosis of non-GCB DLBCL, MCL, FL, WM, or CLL/SLL.
  • At least one prior therapy meeting the criteria for relevant disease type.
  • Detailed eligibility reviewed when you contact the study team.

Study Summary

This clinical trial is for men and women with previously treated B-cell malignancies.

In recent years, clinical trials with small molecule inhibitors of Btk and PI3K-delta have produced high response rates with few drug-related toxicities in subjects with B-cell malignancies. Specifically, ibrutinib and idelalisib have shown very encouraging results and each have gained FDA approval in specific patient populations, however, some subjects develop progressive disease or resistance after a period of time on these treatments. This study aims to assess the clinical potential and safety of a dual inhibition approach by combining ACP-196, a second generation Btk inhibitor, with ACP-319, a second generation PI3K inhibitor. The study will provide more information about whether this targeted combination therapy can benefit subjects with B-cell malignancies over single agent therapies or traditional chemotherapy combinations without an increase in toxicity.

Subjects will receive ACP-196 and ACP-319 continuously throughout the study as long as they are responding to therapy and not experiencing unacceptable side effects. Both ACP-196 and ACP-319 are administered orally twice daily. After discontinuing treatment, subjects will remain in long-term follow-up until they receive their next therapy.

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