Tag: leukemia clinical trials

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. Richard Furman Discusses Emerging Strategies for the Treatment of CLL & Follicular Lymphoma

In this video from Onc Live, Dr. Richard Furman, Director of the CLL Research Center discusses emerging strategies in the treatment of CLL and follicular lymphoma, specifically citing the use of venetoclax also known as ABT-199.

For patients with CLL the following trials are open to accrual.

New Clinical Trial: Study to Determine the Safety, Pharmacokinetics, & Efficacy of Single Agent CC-122 with Rituximab/Ibrutinib in Patients with Relapsed & Refractory CLL/SLL

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with relapsed or refractory CLL/SLL. The study sponsor is the Celegene Corporation, 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 to 79.
  • Diagnosis of CLL/SLL.
  • Must meet the criteria for relapsed and/or refractory disease.
  • Detailed eligibility reviewed when you contact the study team.

Study Summary

This clinical trial is for men and women with relapsed/refractory CLL/SLL.

Subjects on this study will receive the study drug, CC-122, in combination with rituximab or ibrutinib, or as a single agent. CC-122 is an analog of thalidomide and has multiple activities in CLL, including immune modulation (activation of cells in the immune system) and anti-proliferative activity. CC-122 has also been shown to have a tolerable safety profile with some preliminary signs of efficacy with early human experience. Rituximab is a monoclonal antibody directed against a molecule present on the surface of normal B lymphocytes and CLL cells. Ibrutinib is a BTK inhibitor that has received accelerated approval in the United States for patients with CLL who have received at least one prior therapy. This study will provide more information about the efficacy and safety of CC-122 both as a single agent and in combination with rituximab or ibrutinib in subjects with CLL/SLL.

All subjects will receive CC-122 continuously throughout the study as long as they are responding to therapy and not experiencing unacceptable side effects. Some subjects will receive ibrutinib which will be taken continuously throughout the study. Both CC-122 and ibrutinib will be administered orally once daily. Other subjects will receive rituximab which will be administered intravenously on cycle 1 day 1 and 8, and on day 1 of cycle 3, 5, 7, 9, and 11. After discontinuing treatment, subjects will be contacted every 90 days for follow-up information until disease progression, withdrawal of consent, or loss to follow-up.

Subjects may receive up to forty dollars per visit for the reimbursement of travel expenses.