Category: Clinical Trials

Dr. Richard Furman Discusses CLL/SLL Treatments with Lymphoma Research Foundation

Recently, CLL Program Director, Dr. Richard Furman discussed CLL/SLL treatment options with the Lymphoma Research Foundation. On the topic of future treatments Dr. Furman spoke about the exciting treatment options in the future:

“This is a critical time for treatment in CLL because we are witnessing a change in treatment paradigms. We are for the first time seeing the opportunity to move completely away from a dependence on chemotherapy. These new treatments are highly effective and well tolerated. Three new treatments that have recently been approved include ibrutinib, idelalisib and obinutuzumab. There are also two second-generation BTK inhibitors that work similar to ibrutinib and are well tolerated that are in the pipeline,” Dr. Furman said. Regarding the new agents, Dr. Furman makes it clear. “Not only are they preferable because they are better tolerated but because they are also far more effective. Going forward, there is an eye toward not only short term toxicities, but also long- term health. As we continue to identify new agents, the possibility of living a long and full life with minimal toxicity is real for CLL/SLL patients, which is exciting.”

The new treatments for CLL/SLL are currently open in clinical trials. You can follow the link to our clinical trials website to see which trials are available for CLL/SLL.

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.

New Clinical Trial: A Phase 2 Study to Evaluate the Efficacy & Safety of Copanlisib in Patients with Relapsed/Refractory MCL, who Failed Ibrutinib Treatment or Were Unable to Tolerate Ibrutinib

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with refractory MCL, who have failed ibrutinib treatment or were unable to tolerate ibrutinib. The study sponsor is the Bayer Corporation, and the principal investigator at Weill Cornell is Peter Martin 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 with histologically confirmed MCL.
  • Ibrutinib as the last anti-cancer treatment.
  • Availability of fresh tumor tissue.
  • Detailed eligibility reviewed when you contact the study team.

Study Summary 

This clinical trial is for men and women with mantle cell lymphoma (MCL) who were previously treated for this disease and who failed ibrutinib treatment or were unable to tolerate ibrutinib treatment.

While treatment of MCL with ibrutinib has yielded promising efficacy, clinicians and researchers are reporting the development of ibrutinib resistance. Clinically, ibrutinib resistance leaves MCL patients without an established recourse for further treatment. Offering a treatment targeting a different pathway provides an opportunity to fulfill an unmet medical need in this patient population. In addition, some patients are unable to tolerate ibrutinib treatment, leaving them without an established therapeutic option after first-line treatment failure.

This is a single-arm, open-label phase 2a study to evaluate the efficacy and safety of copanlisib monotherapy in patients with MCL, who failed ibrutinib treatment or were unable to tolerate ibrutinib. Patients will receive copanlisib IV infusion at a starting dose of 60 mg as single agent on Days 1, 8 and 15 of each 28-day treatment cycle. Patients will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects. All patients, except for patients who object to follow-up data collection, will be followed for overall survival at least every 3 months during the survival follow-up period until death or until the end of study, whichever occurs first.