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.

ACP-196 Displays A Favorable Safety Profile for Patients with Relapsed/Refractory CLL

Dr. Richard Furman
Dr. Richard Furman

This Phase 1/2 trial was designed to evaluate the safety profile and efficacy of orally administered ACP-196 in patients with relapsed or refractory CLL/SLL. ACP-196 is a second generation BTK inhibitor that is more selective than the first generation BTK inhibitor ibrutinib. Bruton’s tyrosine kinase (BTK) is an enzyme involved in B cell receptor pathway signaling that has been shown to be critical for CLL cell survival. Trials with ibrutinib established BTK as an effective therapeutic target for the treatment of CLL.

As part of the trial, patients were treated continuously with escalating doses of ACP-196, once or twice daily. No dose limiting toxicities were identified and 100 mg twice daily was established as the most efficacious dose. The median age of the patients and number of prior therapies were 62 years and 3 prior therapies respectively. The median time on the study was 10.3 months. As of June 2015 there were 60 patients who were evaluable for response.

The overall response rate was 93% for all patients and 100% in the deletion 17p patient. ACP-196 was well tolerated, with 93% of patients remaining on treatment. The most common adverse events were headache and diarrhea. No disease progression has occurred to date.

Results from this study show that ACP-196 is a highly potent and selective oral BTK inhibitor with a favorable safety profile. Currently there is a Phase 3 trial comparing ACP-196 to Ibrutinib in Patients with High Risk CLL open to eligible patients at Weill Cornell Medicine.

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.