Tag: ibrutinib

Effectiveness of Ibrutinib Treatment in Patients with Relapsed or Refractory CLL/SLL with del17p

Dr. Richard Furman
Dr. Richard Furman

CLL patients with a deletion of chromosome 17p on iFISH demonstrate an aggressive course with rapid disease progression and resistance to chemotherapy. The 17p status had been previously confirmed by iFish a test that examines individual cells for chromosomal changes that are significant in predicting disease outcome The missing portion  of chromosome 17 contains the gene for p53, which is one of the most important tumor suppressor genes. The Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib has demonstrated efficacy for patients with the del17p and been approved by the FDA.

In this trial, CLL patients with del17p received ibrutinib once daily until disease progression or unacceptable toxicity.  63% of patients were Rai stage III or IV and 39% had received ≥3 prior therapies. At the median follow-up of 11.5 months, the overall response rate  for all patients was 83%, with a 12 month progression free survival and overall survival  of 79% and 84% respectively.

These results provide further evidence of ibrutinib’s efficacy in prolonging the survival of high risk patients. For more information about available trials for CLL/SLL at Weill Cornell Medicine please follow the link to our new clinical trials listing.

Dr. Peter Martin Describes a Copanlisib Trial for Mantle Cell Lymphoma Patients who have Previously Failed Ibrutinib Treatment

In this video Dr. Peter Martin describes the benefits of a recently opened clinical trial evaluating the efficacy and safety of copanlisib for mantle cell lymphoma (MCL) patients, who have failed or were unable to tolerate ibrutinib treatment. The purpose of this study is to to evaluate the efficacy and safety of copanlisib monotherapy in patients with MCL.

If you’re interested in participating in this trial please call 212-746-2919 for more information. A full listing of MCL trials at Weill Cornell Medicine can be found here.

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.