Tag: chronic lymphocytic leukemia

Ibrutinib is Effective Therapy for Relapsed CLL Patients

Reporting results in the New England Journal of Medicine, Weill Cornell’s Dr. Richard Furman and others recently completed a large phase 1b/2 clinical trial on the effects of ibrutinib in patients with Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). Recently granted a third breakthrough therapy designation as a monotherapy for CLL and SLL, ibrutinib acts as an oral, irreversible inhibitor of the enzyme, Bruton tyrosine kinase (BTK).  BTK is an essential component of the B-cell receptor signaling pathway and  facilitates interactions between the CLL cells and their micro-environment, promoting the survival of CLL/SLL cells.

In the clinical study, ibrutinib was administered orally to 85 previously treated patients with CLL once daily at doses of 420 mg and 840 mg. Both doses demonstrated an overall response rate of 71%, with an additional 20% and 15% in each group achieving a partial response with lymphocytosis. At a median follow up of 26 months, estimated progression-free and overall survival for the 85 patients overall were 75% and 83% respectively. Side effects were mild and included diarrhea, fatigue, and infections. The study concluded that ibrutinib produces, “a high frequency of durable remissions for relapsed or refractory CLL/SLL, including those patients with high-risk genetic lesions.”

Ibrutinib represents an important improvement in the treatment of patients with CLL/SLL.  Treatment previously consisted of regimens utilizing chemotherapies, including chlorambucil, cyclophosphamide, fludarabine, and bendamustine in various combinations that effectively generated responses in patients, but with significant toxicities.  Ultimately, patients relapsed and became unresponsive to or unable to tolerate chemotherapy.  Additionally, the subset of patients characterized by having del 17p13.1  who respond extremely poorly to chemoimmunotherapy, demonstrated response rates equivalent to the rest of the patient population.

Currently there are ongoing trials of ibrutinib in CLL and other lymphomas at the Weill Cornell CLL Research Center and Lymphoma Program. Additional clinical trials are available here.

Ibrutinib Granted Third Breakthrough Status for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)

On April 8, the FDA granted a third Breakthrough Therapy Designation for the investigational agent ibrutinib. Previously, receiving breakthrough status for the treatment of patients with Waldenström’s macroglobulinemia and mantle cell lymphoma, the drug has now achieved breakthrough status as a monotherapy for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in patients with deletion of the short arm of chromosome 17 (deletion 17p). This is an especially important development as CLL and SLL affected carriers of the deletion of chromosome 17 mutation are prone to poor prognoses, often due to their poor responses to chemoimmunotherapy.

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 testing 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 Program open to patients with CLL and SLL. Additional clinical trials for Waldenström’s macroglobulinemia and mantle cell lymphoma with ibrutinib are ongoing.

Please stay updated with our clinical trials listing for forthcoming trials involving ibrutinib and the Cornell Lymphoma Program website for further clinical research updates.

New Clinical Trial: GS-1101 in Combination with Bendamustine and Rituximab for Previously Treated CLL

Update: this study is closed to enrollment. 

The Weill Cornell Lymphoma Program is now recruiting men and women with previously treated, recurrent chronic lymphocytic leukemia (CLL) for a clinical trial evaluating the experimental drug GS-1101 (also called Idelalisib, formerly called CAL-101), combined with bendamustine and rituximab, in treating CLL. The study sponsor is Gilead Sciences, Inc, 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
  • Age 18 and older
  • Diagnosis of B-cell chronic lymphocytic leukemia (CLL)
  • Previously treated for CLL
  • Detailed eligibility reviewed when you contact the study team
Study Details

GS-1101 (CAL-101) is a pill designed to block some of the cell functions that cause CLL to grow and survive and may help control the disease. Rituximab and bendamustine are approved by the FDA as a treatment for CLL. The study will help determine whether adding GS-1101 (CAL-101) to the standard treatment of rituximab and bendamustine will have a better effect on controlling CLL.

Study participants will be randomly assigned to one of two treatment groups:

  • Group A: GS-1101 and rituximab/bendamustine
  • Group B: Rituximab/bendamustine and placebo (an inactive pill that looks like GS-1101 but contains no medicine)

After 20 weeks of therapy with rituximab, bendamustine and GS-1101 or placebo, participants will continue with GS-1101 or placebo as long as their CLL is controlled.