New Clinical Trial: A Phase 3 Study of ACP-196 vs. Ibrutinib in Previously Treated Subjects with High Risk Chronic Lymphocytic Leukemia

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with previously-treated high-risk (17p deletion or 11q deletion) CLL. The study sponsor is Acerta Pharma BV, 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 CLL with high-risk prognostic factors (17p deletion or 11q deletion)
  • At least one prior therapy
  • Detailed eligibility reviewed when you contact the study team

Study Summary

This clinical trial is for men and women with previously-treated high-risk (17p deletion or 11q deletion) CLL.

In February 2014, ibrutinib (IMBRUVICA®) monotherapy, the first Btk inhibitor developed for clinical use, was awarded marketing approval in the United States for the treatment of patients with CLL who have had ≥ 1 prior therapy or 17p deletion based on high response rates with few drug-related toxicities. However, ibrutinib is not without its adverse reactions. Furthermore, subjects with 17p deletion have shown the poorest outcome on ibrutinib treatment. This study will evaluate the safety and activity of a potent, second-generation Btk inhibitor, ACP-196, versus ibrutinib in subjects with previously treated CLL with high-risk cytogenetics (such as 17p deletion). ACP-196 has been well tolerated in healthy volunteers and subjects with CLL or Richter’s syndrome. Despite poor prognostic characteristics in the CLL study population, ACP-196 has induced sustained decreases in lymphadenopathy, and based on the current existing data, provides more rapid reduction and/or resolution of lymphocytosis than ibrutinib. Additionally, no specific drug-related toxicity has been identified to date for ACP-196. The study will provide more information about whether ACP-196 can benefit subjects with high risk CLL over ibrutinib treatment in terms of safety and efficacy.

Subjects will be randomized to receive either ACP-196 orally twice daily or ibrutinib orally once daily. Both treatments are to be taken continuously throughout the study as long as they are responding to therapy and not experience unacceptable side effects. After discontinuing treatment, subjects will remain in long-term follow-up until loss to follow-up, consent withdrawal, or study closure.

Dr. John Leonard Discusses How He Treats Mantle Cell Lymphoma

During the American Society of Hematology’s inaugural meeting on mantle cell lymphoma (MCL), Lymphoma Program Director, Dr. John Leonard discussed his treatment approach to patients with MCL. As TargetedOncology notes Dr. Leonard’s approach includes two key principles:

The first is to observe patients with asymptomatic MCL for as long as possible. In discussing the watch-and-wait approach, Leonard referred colleagues to data from the 2009 study that he co-authored in the Journal of Clinical Oncology, “Outcome of Deferred Initial Therapy in Mantle-Cell Lymphoma.”1 The overall survival (OS) of patients in the observation group exceeded that of patients in the early treatment group.

The second key principle that he suggested was to begin with less intensive initial treatments when needed due to their lower toxicity levels. “It’s true that less intensive treatments might have more chronic toxicity, but intensive treatments are unquestionably more toxic in the short term and can have longer-term toxicities as well,” he said.

You can read the rest of the article for a more in-depth summary of Dr. Leonard’s approach to treating patients with MCL.

REDLAMP 11: Does a Family History of Lymphoma Increase My Risk?

Great strides in the understanding of familial predisposition to common forms of lymphoma including non-Hodgkin lymphoma, Hodgkin lymphoma, and chronic lymphocytic leukemia have been made in the past decade. Many lymphoma patients wonder if their family faces an increased risk. In this video Dr. Peter Martin explains the results from a recent study published in Blood, which sought to quantify these risks, and give a better understanding of how a family history of lymphoma increases the risk for other family members.

Previous #REDLAMP entries can be viewed on our Youtube channel.

We encourage you to follow the Lymphoma Program on Twitter, Youtube, and Facebook where we will highlight new videos are about research publications as they are released. We also welcome your feedback, suggestions and questions about this project. If you have other questions about our lymphoma program or clinical trials or would like to see one of our lymphoma specialists, please contact us at 212-746-2919.