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.
Category: Clinical Trials
New Clinical Trial: Phase 2 Study Evaluating the Efficacy and Safety of Idelalisib in Combination with Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia with 17p Deletion
The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with chronic lymphocytic leukemia. The study sponsor is Gilead Sciences, Inc., and the principal investigator at Weill Cornell is Richard Furman, 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 age 18 and older
- Diagnosis of CLL with 17p deletion
- No prior therapy for CLL other than corticosteroids for disease complications
- Detailed eligibility reviewed when you contact the study team
Study Details
This clinical trial is for men and women with previously untreated CLL with 17p Deletion.
Patients with 17p deleted CLL have particularly aggressive courses characterized by a lack of response to chemotherapy. Standard treatment for patients who are previously untreated is chemotherapy that carries significant risks without the likelihood of significant benefit. Idelalisib has demonstrated excellent activity and tolerability in patients with relapsed and refractory 17p deleted CLL. This study will provide more information about whether giving rituximab and idelalisib together can benefit patients with previously untreated CLL who have a 17p deletion.
Subjects will receive rituximab for 8 weeks and Idelalisib continuously throughout the study (up to 10 years) as long as they are responding to therapy and not experiencing unacceptable side effects. Rituximab is administered intravenously once weekly. Idelalisib is administered orally twice daily. After discontinuing treatment, follow-up information will be collected once every year throughout the study (up to 10 years) at clinic visits or through telephone calls.
Subjects will be provided a stipend for each study visit to reimburse the cost of travel and other expenses.
New Clinical Trial: Phase 3 Study to Compare Rituximab + Lenalidomide to Rituximab + Placebo in Patients with Relapsed/Refractory Indolent Lymphoma
The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with relapsed/refractory indolent lymphoma. The study sponsor is the Celgene Corporation, and the principal investigator at Weill Cornell is Dr. John Leonard. 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
- Histologically confirmed MZL or Grade 1,2, or 3a FL
- Relapsed, refractory, or progressive disease after treatment with systemic therapy, and must be rituximab-sensitive if had received rituximab or R-chemo regimen therapy
- Detailed eligibility reviewed when you contact the study team
Study Details
This phase 3 multicenter, double-blind, randomized study is designed to evaluate the efficacy and safety of rituximab plus lenalidomide versus rituximab plus placebo. Subjects must have an investigator-assessed diagnosis of relapsed/refractory indolent lymphoma, defined in this clinical trial as Grade 1, 2 or 3a follicular lymphoma or marginal zone lymphoma, must have been previously treated for their lymphoma with systemic therapy (chemotherapy, immunotherapy, or chemo immunotherapy), must be refractory to or have relapsed after their last treatment, may be rituximab-naïve or rituximab-sensitive, must have at least one measurable lesion by computed axial tomography (CT) or magnetic resonance imaging (MRI) scan, and must have adequate bone marrow function, liver function and renal function.
The study is divided into the Screening Period (up to 28 days), Treatment Period (up to 12 28-day cycles), and Follow-up Period. Approximately 350 subjects are planned to be randomized with 5 subjects at WCMC. Each patient will receive rituximab weekly during cycle 1 and then on day 1 of cycles 2-5. Depending on randomization, subjects will also receive either lenalidomide or placebo on days 1-21 of cycles 1-12.
New Developments in Lymphoma 