New Clinical Trial: Open-label, Phase 2 Study of ACP-196 in Subjects with Mantle Cell Lymphoma

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with mantle cell lymphoma. The study sponsor is Acerta Pharma BV, 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 greater than or equal to 18 years of age
  • Patient has confirmed Mantle Cell Lymphoma (MCL)
  • The disease has relapsed after or been refractory to at least 1 prior therapy for MCL
  • Detailed eligibility reviewed when you contact the study team

Study Details

The purpose of this study is to determine the activity of ACP-196 in subjects with relapsed or refractory MCL as measured by response rate, duration of response, progression-free survival, and time-to-next treatment.

The design and conduct of this study is supported by an understanding of the natural history and current therapies for subjects with lymphoid cancers; knowledge of the activity and safety of the first-generation Btk inhibitor (eg, ibrutinib) in subjects with hematologic cancers; and the available nonclinical and clinical information regarding ACP-196.

This study is a multicenter, open-label, randomized, parallel group study. No placebo will be administered during this study. Twenty subjects, 10 refractory and 10 relapsed, will be enrolled and will take 100 mg of ACP-196 twice per day.

This clinical trial is a Phase 2, multicenter, open-label study. Subjects will be enrolled and will take 100 mg of ACP-196 twice per day (BID) continuously for approximately 14 months. Patients will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.

Lymphoma Program Establishes Partnership to Advance Development of Targeted Lymphoma Therapies

The Lymphoma Program has recently established a cross-campus experimental therapeutics collaboration between Weill Cornell Medical College and Cornell University. Known as the Progressive Assessment of Therapeutics, or P.A.Th. this partnership will harness the already existing infrastructure at the two university sites for the purpose of advancing a more rapid bench to bedside discovery process for the clinical introduction of targeted therapies.

Dr. Kristy Richards
Dr. Kristy Richards

The P.A.Th. program will be overseen by co-directors Dr. Kristy Richards and Dr. Leandro Cerchietti. Dr. Richards is an expert in comparative oncology and oncogenomics, which emphasizes the genetic/genomic approaches to understanding the biology and treatment of hematologic malignancies. Her research involves genetic mapping and genetic association approaches to understanding drug resistance in a variety of agents used to treat hematologic malignancies. Dr. Cerchietti is an expert in experimental therapeutics in lymphomas. His research involves developing of pharmacokinetic and pharmacodynamics biomarkers to personalize treatment regimens in pre-clinical and clinical settings.

Dr. Leandro Cerchietti
Dr. Leandro Cerchietti

In practice the collaborative program will improve the speed and accuracy of the clinical trial process, while streamlining the organization required to bring new treatments through the laboratory to the patient’s bedside. It has already seen tangible results in a recently published paper. This approach will have different manifestations. For patients with DLBCL, cell lines are the workhorse in the early development of treatments. However, the numbers and diversity of DLBCL cell lines is small, while more indolent lymphoma cell lines are difficult to maintain. Through the P.A.Th. program in collaboration with Dr. Ankur Singh of the Sibley School of Mechanical and Aerospace Engineering, researchers are developing 3-D tissue culture (organoids) on lattices that more closely simulate the micro-environment of a lymph node. This would allow for lymphoma cells taken from patients to be more successfully cultured and easily researched. The ease of developing and curating new and longer lasting cell cultures could lead to faster breakthroughs in the development of treatments.

Another focus of the P.A.Th. program is the use of better mouse models and the inclusion of pet dogs as a model for human lymphoma. Pet dogs can enroll in clinical trials, much the same way human patients can, yet this resource has mostly been overlooked.  Given Cornell University’s top-ranked veterinary school, and the high incidence of lymphoma in pet dogs, this is a resource that the P.A.Th. program is using to increase their clinical trial capacity in lymphoma research. This will save the lives of both 2 legged and 4 legged patients.

Taken together these improvements and others should make for a comparatively quicker and more accurate therapeutic development strategy. Considering, its multidisciplinary approach and high quality capabilities this collaboration is poised to be a leader in the development of new therapeutics for lymphoma. As Dr. Richards, noted, “Think of this P.A.Th. program as a bridge that connects the incredible lymphoma basic and translational research that is already happening throughout the Cornell campuses, with Cornell’s excellent patient care. The results will provide a very compelling therapeutic development strategy that should provide hope to patients with lymphoma and other types of cancer.”

Dr. Peter Martin Explains a Trial Testing the Combination of Ibrutinib + Palbociclib for Patients with Previously Treated Mantle Cell Lymphoma

In this video Dr. Peter Martin explains the benefits of a recently opened phase I trial of ibrutinib plus palbociclib for patients with previously treated mantle cell lymphoma (MCL). The trial will evaluate the safety and activity of the combination. This is a Weill Cornell Medical College investigator-initiated clinical trial, sponsored by the Cancer Therapy Evaluation Program at the National Cancer Institute.

If you’re interested in participating in this trial please call 646-962-2074 for more information.