Category: Clinical Trials

Lymphoma in the News: No Benefit to Rituximab Maintenance Following Autologous Stem Cell Transplantation in Patients with Relapsed DLBCL

By Peter Martin, MD

Patients with diffuse large B-cell lymphoma (DLBCL) that has relapsed following first-line chemotherapy are typically offered second-line chemotherapy followed by autologous stem cell transplantation (bone marrow transplantation using the patient’s own stem cells).

The CORAL study, a recently completed international phase 3 trial, evaluated whether rituximab following the transplant procedure could improve patient outcomes. The results of the study were recently presented at the American Society of Clinical Oncology (ASCO) annual meeting.

Following second-line chemotherapy (R-ICE or R-DHAP) and stem cell transplant, 242 patients were randomized to receive rituximab given every two months for one year or observation. By four years, there was no difference in rate of progression or survival between the two groups. Interestingly, women that received rituximab maintenance did considerably better than men that received rituximab maintenance while there was no difference in outcomes between the two genders in the observation group.

Based on these results, there does not appear to be an advantage to rituximab maintenance following stem cell transplantation for DLBCL.

Click here to read the abstract of the CORAL study results as presented at the ASCO annual meeting.

Lymphoma in the News: R-CHOP 21 Remains Standard of Care for Diffuse Large B-Cell Lymphoma

By Peter Martin, MD

Several studies have demonstrated that rituximab (R) added to CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone) can improve the outcomes of patients with diffuse large B-cell lymphoma (DLBLC). Nonetheless, there remains room for improvement.

A German study from the pre-rituximab era demonstrated that giving CHOP chemotherapy every two weeks (i.e., CHOP-14) was better than given CHOP every three weeks (i.e., CHOP-21) in patients older than 60 years of age. This type of therapy is also referred to as “dose-dense” therapy, and it is attractive because it theoretically allows less time for cancer cells to grow between chemotherapy cycles. The question of whether CHOP-14 would remain superior to CHOP-21 even after the addition of rituximab is the subject of two ongoing phase 3 clinical trials, one in France and one in the United Kingdom (UK). Dr. David Cunningham presented the results of the latter trial at the recent meeting of the American Society of Clinical Oncology (ASCO) in Chicago. After a median follow-up of about three years, there was no difference in survival between patients treated with R-CHOP-14 or R-CHOP-21. Click here to see the study abstract. These results are consistent with preliminary results from the French study presented in 2010 and confirm that R-CHOP 21 should remain the standard of care for most patients with DLBCL.

At Weill Cornell Medical Center, we believe that improvements in patient outcomes are likely to come from the addition of  newer, targeted drugs to R-CHOP rather than increasing the dose or density of  older chemotherapy regimens.

Clinical Trial: Bruton’s Tyrosine Kinase (Btk) Inhibitor PCI-32765 in Relapsed/Refractory Mantle Cell Lymphoma

Update: this study is closed to enrollment. 

Bruton tyrosine kinase (Btk) is an enzyme that plays a crucial role in the development of the normal immune system. Recent studies indicate that Btk may also play a role in many B-cell lymphomas.

PCI-32765 is an investigational drug that irreversibly inhibits Btk. A phase 1 trials performed at several sites, including Weill Cornell Medical Center, demonstrated that PCI-32765 was well tolerated with minimal side effects.

In this phase 2 study, we are evaluating the efficacy of PCI-32765 (four pills take once daily) in patients with previously treated mantle cell lymphoma. We hope to learn how well PCI-32765 works and more about its side-effect profile.

To learn more about this study, please contact June Greenberg, RN at (212) 746-2651 or email June at jdg2002@med.cornell.edu.

Click here to view the clinical and research profile of Peter Martin, MD, the physician leading the study at Weill Cornell Medical Center.