New Clinical Trial: Phase 2 Open-Label Study of the Efficacy & Safety of ABT-199 in CLL Subjects with Relapsed or Refractory to B-cell Receptor Signaling Pathway Inhibitor Therapy

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with Chronic Lymphocytic Leukemia (CLL). The study sponsor is AbbVie, 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 CLL that is relapsed/refractory with an indication for treatment.
• Disease is refractory or relapsed after therapy with ibrutinib or idelalisib.
• Detailed eligibility reviewed when you contact the study team.

Study Details 

This clinical trial is for men and women with CLL that is relapsed/refractory to B-cell receptor (BCR) signaling pathway inhibitor therapy, specifically idelalisib or ibrutinib.

In recent years, clinical trials with idelalisib and ibrutinib 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. The study drug ABT-199 is a Bcl-2 family protein inhibitor that has shown a favorable benefit to risk ratio and strong activity in subjects with refractory CLL in clinical data to date, and has a mechanism of action that is independent of the BCR pathway. This study will provide more information about whether ABT-199 can benefit patients with CLL that is relapsed/refractory to idelalisib or ibrutinib.

Subjects will receive ABT-199 orally once daily, continuously throughout the study (up to 2 years following the date of the last subject enrolled) as long as they are responding to therapy and not experiencing unacceptable side effects. After discontinuing treatment, follow-up information will be collected every 3 months at clinic visits or through telephone calls for up to 3 years.

Subject will be eligible for reimbursement for travel expenses, and for lodging expenses incurred by the spouse/caregiver who provides transportation and/or assistance during study required hospital stays.

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. View all posts by lymphomaprogram