In his words, Dr. Peter Martin, explains a recently opened phase 1 trial testing the combination of azacitidine plus R-CHOP in patients with high risk previously untreated diffuse large B-cell lymphoma (DLBCL) or grade 3B follicular lymphoma.
Tag: R-CHOP
New Clinical Trial: Ibrutinib in Combination with Bendamustine & Rituximab or R-CHOP in Subjects with Previously Treated Indolent Non-Hodgkin Lymphoma
The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with previously treated follicular or marginal zone lymphoma. The study sponsor is Janssen Research & Development LLC., and the principal investigator at Weill Cornell is Dr. Peter Martin. 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:
- Open to men and women age 18 and older
- Follicular or Marginal Zone Non-Hodgkin lymphoma
- Relapsed or Refractory after receiving at least one prior chemotherapy regimen
- At least one site of measurable disease
- Detailed eligibility reviewed when you contact the study team
Study Details
The purpose of this study is to compare whether adding ibrutinib to the standard chemotherapy options for this population bendamustine & rituximab (BR) or R-CHOP results in a longer progression-free survival than BR or R-CHOP alone. The type of chemotherapy that the patient will receive will be dependent on refractory versus relapsed disease, type of indolent non-Hodgkin Lymphoma, and number of prior lines of therapy.
Treatment Plans
All participants will be randomized (randomly) in a one to one ratio to receive the study drug, ibrutinib, or placebo.
Randomization arms: This study is comparing BR or R-CHOP in combination with ibrutinib or placebo. This is a double blind study so neither the patient or the physician will know if they are receiving the study medication, ibrutinib or placebo. The placebo is a blank pill that will look similar to ibrutinib but contains no medicine. The physicians will decide whether patients will receive BR or R-CHOP chemotherapy depending on prior treatments.
Patients will receive the standard 6 cycles of BR or R-CHOP and will continue taking ibrutinib or placebo as long as they are responding to therapy and not experiencing unacceptable side effects.
ASCO 2013: Ibrutinib Combined with R-CHOP Shows Positive Results in Patients with CD20-positive, B-cell non-Hodgkin Lymphoma
Ibrutinib is a first-in-class oral Bruton’s tyrosine kinase inhibitor that has shown promise in treating a variety of relapsed and refractory B-cell malignancies. At the 2013 meeting of the American Society of Clinical Oncology in Chicago, Dr. Anas Younes of the MD Anderson Cancer Center presented results from a recent phase 1b trial combining ibrutinib with standard doses of R-CHOP in patients with previously untreated CD20 positive NHL (NCT01569750).
A total of seventeen patients were enrolled, including those with subtypes of diffuse large B-cell lymphoma, mantle cell lymphoma, and follicular lymphoma. The recommended phase 2 dose of ibrutinib was established at 560 mg daily in combination with standard doses of R-CHOP given every 21 days. The overall response rate of treatment was 100% with 7 complete and 3 partial responses in 10 evaluable patients. The most common adverse events were neutropenia (77%), thrombocytopenia (65%), vomiting (59%), anemia (53%), nausea (47%), fatigue (35%), headaches (29%), constipation (24%), diarrhea (24%), and dizziness (24%).
The study concluded that this novel combination of Ibrutinib and R-CHOP has an acceptable and expected safety profile. An expansion cohort 560 mg ibrutinib is being opened to further explore the safety and efficacy of IR-CHOP in patients with newly diagnosed diffuse large B-cell lymphomas.
For a full listing of all current clinical trials underway in the Lymphoma Program, please click here.
New Developments in Lymphoma 