Dose-Adjusted EPOCH-Rituximab Shows Encouraging Results for Patients with Primary Mediastinal B-Cell Lymphoma

Initially recognized in the 1980s, primary mediastinal B-cell lymphoma (PMBCL) is a subtype of diffuse large B-cell lymphoma (DLBCL) arising in the thymus. Representing less than 3% of non-Hodgkin lymphoma cases, PMBCL has a skewed age distribution affecting young adults, especially young women. Historically, patients with PMBCL have been treated with mediastinal radiation following chemotherapy based on evidence that chemotherapy alone was insufficient. Despite the high cure rates with this strategy, mediastinal radiation in young patients can be associated with late adverse effects, including premature cardiovascular disease and secondary cancers.

Researchers from the National Cancer Institute (NCI) and their partner institutions recently completed a phase II study of infusional dose-adjusted etoposide, doxorubicin, and cyclophosphamide with vincristine, prednisone, and rituximab (DA-EPOCH-R) with no mediastinal radiation complement. In 51 patients with a median age of 30 years, of which 59% were women, the overall survival rate was 97% at the median 5-year follow-up. From these results, researchers suggested that DA-EPOCH-R therapy obviated the need for radiotherapy in patients with PMBCL.  

While these results from this phase II study are encouraging, they will need to be confirmed with further research.

New Clinical Trial: Ibrutinib in Relapsed/Refractory CLL/SLL with 17p Deletion

Update: this study is closed to enrollment. 

The Weill Cornell Lymphoma Program is now recruiting men and women with relapsed or refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) with 17p deletion for a new clinical trial evaluating the experimental drug ibrutinib. The study sponsor is Pharmacyclics, and the principal investigator at Weill Cornell is Dr. Richard Furman. 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
  • Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) with 17p deletion
  • Relapsed or refractory disease after receiving at least one prior line line of systemic therapy which included at least two cycles of chemotherapy or immunotherapy for CLL/SLL
  • Detailed eligibility reviewed when you contact the study team
Study Details

Ibrutinib (also known as PCI-32765) is a type of drug called a kinase inhibitor; the drug blocks an enzyme that helps cancer cells live and grow. By blocking the enzyme, it is possible that ibrutinib will kill cancer cells or stop them from growing.

The purpose of the study is to determine whether ibrutinib is safe and effective in treating CLL/SLL with 17p deletion.

Treatment Plan

All study participants will receive ibrutinib; there is no placebo in this study. Participants will take 3 capsules by mouth once a day and continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.

Ibrutinib Granted Third Breakthrough Status for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)

On April 8, the FDA granted a third Breakthrough Therapy Designation for the investigational agent ibrutinib. Previously, receiving breakthrough status for the treatment of patients with Waldenström’s macroglobulinemia and mantle cell lymphoma, the drug has now achieved breakthrough status as a monotherapy for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in patients with deletion of the short arm of chromosome 17 (deletion 17p). This is an especially important development as CLL and SLL affected carriers of the deletion of chromosome 17 mutation are prone to poor prognoses, often due to their poor responses to chemoimmunotherapy.

Ibrutinib, an oral drug designed to specifically target an enzyme called Bruton’s tyrosine kinase (BTK), has demonstrated promising activity in multiple phase 1 and 2 clinical trials performed at Weill Cornell Medical College and around the world. As one of the leading institutions in the study of ibrutinib since its first testing 3 years ago, Weill Cornell is uniquely positioned in its experience with ibrutinib.

Currently, there are ongoing ibrutinib clinical trials at the Weill Cornell Lymphoma Program open to patients with CLL and SLL. Additional clinical trials for Waldenström’s macroglobulinemia and mantle cell lymphoma with ibrutinib are ongoing.

Please stay updated with our clinical trials listing for forthcoming trials involving ibrutinib and the Cornell Lymphoma Program website for further clinical research updates.