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.

New Clinical Trial: A Phase 2 Study of the Efficacy & Safety of ACP-196 in Patients with Relapsed/Refractory CLL who are Intolerant to Ibrutinib Therapy

The Weill Cornell Lymphoma Program has recently opened a new research study for men and women with previously-treated chronic lymphocytic leukemia (CLL) who are intolerant to ibrutinib. The study is sponsored by the Acerta Pharma BV and the principal investigator is John Allan, MD. For more information about the study, please call Amelyn Rodriguez at 212-746-1362 or email her at amr2017@med.cornell.edu.

Key Eligibility

  • Men and women age 18 and older.
  • Diagnosis of CLL.
  • At least one prior therapy for CLL.
  • Intolerant to ibrutinib.
  • Detailed eligibility reviewed when you contact the study team.

Study Summary

Btk inhibition is an established therapeutic intervention for the treatment of CLL. In February 2014, ibrutinib (IMBRUVICA®) monotherapy, the first Btk inhibitor developed for clinical use, was approved 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. This study will evaluate the safety and efficacy of the second-generation Btk inhibitor, ACP-196, in subjects who have previously discontinued ibrutinib therapy due to adverse reactions. Preliminary data to date suggests that ACP-196 is very well tolerated and has robust activity as a single agent in the treatment of subjects with relapsed/refractory CLL. Additionally, PK/PD results show the 100-mg BID regimen produces optimal target coverage over 24 hours, which may provide greater clinical benefit than the QD regimen of ibrutinib. This study will explore whether ACP-196, as an alternative Btk inhibitor, with a potentially distinct safety profile, may fill an unmet need in therapeutic options for patients who are intolerant to ibrutinib.

Subjects will receive ACP-196 orally twice daily continuously throughout the study as long as they are responding to therapy and not experiencing unacceptable side effects. Subjects who are continuing to tolerate and derive clinical benefit from treatment at the end of the trial may continue to receive their study treatment after discussion with the medical monitor. After discontinuing treatment, subjects will remain in long-term follow-up until loss to follow-up, consent withdrawal, or study closure.

LAM-002A: What You Should Know about this Agent for B-cell Non-Hodgkin Lymphoma

What is LAM-002A?  

LAM-002A is an oral selective kinase inhibitor currently undergoing Phase I trials for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma. These trials seek to evaluate the safety, tolerability, and pharmacokinetics of LAM-002A. Before investigation of LAM-002A in patients with lymphoma, it was studied and found to be safe in patients with psoriasis, rheumatoid arthritis (RA) and Crohn’s disease.

How does LAM-002 work?

Also known as apilimod dimesylate, LAM-002 is a potent and highly selective PIKfyve kinase inhibitor. It is the first compound in this class.  Kinases are proteins that modify cell functions. Lymphomas can arise from overactive or high levels of kinases. LAM-002 disrupts the normal activity of this particular kinase, which can lead to death of cancer cells.

What are the side effects?

In previous studies of patients with psoriasis, RA and Crohn’s disease, LAM-002 was well tolerated, with most side effects assessed as mild in severity. The most frequent side effects included headaches, upper respiratory tract infection, and nausea. To date all available nonclinical and clinical data support the safety profile of LAM-002A in patients with non-Hodgkin lymphoma.

How can you access LAM-002A?

LAM-002A is available through a recently opened Phase I trial for men and women with previously-treated B-cell non-Hodgkin lymphoma in the Lymphoma Program at Weill Cornell Medicine.

A full list of trials open at WCM for patients with non-Hodgkin lymphoma is available on our Joint Clinical Trials website.

Dr. Peter Martin Discusses Transplantation as a Treatment Option for Patients with Mantle Cell Lymphoma

In an interview with the Lymphoma Research Foundation (LRF), Dr. Peter Martin discusses mantle cell lymphoma (MCL), treatment options including transplantation, and what advice he would give to people who are newly diagnosed with MCL.

Debate exists among researchers on whether or when stem cell transplantation should be used in the treatment of MCL. Why do you think this is so?

…

“Some people feel that stem cell transplantation is likely to make a patient live longer and others feel that a long remission duration following a stem cell transplant means there are fewer lymphoma-related side effects, and everybody likes that idea.

On the other hand, autologous stem cell transplantation doesn’t cure MCL. There are limited data that suggest that it may allow people to live longer, and many patients may experience significant side effects but not have a very durable remission and a longer life. So that’s a very subjective sort of decision based on less than perfect evidence.

It’s our job as lymphoma doctors to help patients understand the potential benefits and the potential negative side effects to all treatment options so they can select a treatment that is best for them. There’s no right or wrong treatment option in many cases and it’s a matter of choosing the option that makes the most sense for that person at that point in time.”

The full interview can be read on the LRF’s website.