Tag: marginal zone lymphoma

2018 American Society of Hematology (ASH) Annual Meeting

The American Society of Hematology (ASH) is the world’s largest professional society serving clinicians and scientists who work to conquer blood diseases. The ASH Annual Meeting & Exposition brings together over 25,000 hematology professionals from around the world to discuss the understanding, diagnosis, treatment, and prevention of disorders affecting the blood, bone marrow, and immunologic, hemostatic and vascular systems.

This year, the ASH Meeting celebrated its 60th anniversary in San Diego, CA. As always, our team was proud to contribute new lymphoma discoveries for presentation at the meeting. Here are some research highlights from our team.

Dr. John Leonard led a global phase III clinical trial comparing the efficacy and safety of combined lenalidomide plus rituximab versus rituximab alone in people with previously treated indolent lymphoma, including follicular and marginal zone lymphoma. Results demonstrating lenalidomide-rituximab as an important new treatment option for this patient population.

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Dr. Richard Furman and colleagues found that at follow-up of up to seven years, ibrutinib demonstrated sustained activity in both first line and relapsed/refractory chronic lymphocytic leukemia (CLL) patients.

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Dr. Peter Martin led a study examining the safety and efficacy of CC-486, also known as oral azacitidine, plus R-CHOP chemotherapy in people with diffuse large B-cell lymphoma (DLBCL).

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Using a combination of human, animal, and cell line data, Jude Phillip, PhD, of the Leandro Cerchietti Research Lab, and colleagues found that the internal architecture of lymphomas present important insights into disease progression.

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Dr. John Allan presented a preliminary update of an ongoing first-in-human study of vecabrutinib in patients with advanced B-cell malignancies.

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Dr. Sarah Rutherford reported data that may support the elimination of bone marrow biopsies in follicular lymphoma and diffuse large B-cell lymphoma clinical trials.

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Dr. Richard Furman and colleagues found that venetoclax is well tolerated and produces high levels of response in previously treated Waldenstrom’s macroglobulinemia patients.

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We are proud of our team’s continued commitment to advancing the overall understanding of lymphoma and improving clinical outcomes and quality of life for all those affected by the disease.

FDA Approves First-Ever Targeted Marginal Zone Lymphoma Treatment

On January 19, 2017, the United States Food and Drug Administration (FDA) approved ibrutinib to treat patients that have received at least one line of prior therapy for marginal zone lymphoma (MZL), a type of non-Hodgkin lymphoma (NHL).

MZL is an indolent B-cell lymphoma that accounts for 5-10% of all lymphomas and lacks a standard of care. Current MZL treatments include anti-CD-20 antibody therapy (e.g. rituximab) or chemotherapy. However, ibrutinib is the first-ever treatment to specifically be approved for MZL.

Ibrutinib works by inhibiting Bruton’s tyrosine kinase (BTK), an enzyme responsible for transmitting pro-growth and survival signals from the surface of a cell to its nucleus. In this way, ibrutinib may interfere with chronic stimulation arising from inflammation in the tumor microenvironment; thus slowing the growth of B-cells.

The Weill Cornell Lymphoma Program is proud to have played a role in the phase 2 trial — the largest trial to date for people with previously treated MZL of all subtypes —leading to FDA approval for ibrutinib. Roughly half of all patients had a significant response to ibrutinib, with some degree of tumor shrinkage observed in almost 80% of all patients in the trial. Roughly one-third remained on treatment 18 months after beginning treatment.

The most common side effects included fatigue, diarrhea, and anemia. These side effects were manageable, and consistent with previous research, although some cases required the discontinuation of treatment with ibrutinib.

Results from this study support the use of ibrutinib as an effective well tolerated chemotherapy-free option for the treatment of previously treated MZL. However, some questions remain. MZL is a heterogeneous group of lymphomas, and it is unclear which subtypes might respond best to ibrutinib. With only half of all previously treated MZL patients responding to ibrutinib, improvements might be realized by combining ibrutinib with other drugs and/or using it earlier in the treatment of MZL.

At Weill Cornell, we are currently studying ibrutinib in combination with the immunotherapy drug durvalumab in people with previously treated indolent non-Hodgkin lymphoma, including MZL.

New Clinical Trial: Phase 1 Dose-escalation Study Evaluating the Safety, Pharmacodynamics, Pharmacokinetics, & Efficacy of GS-9901 in Subjects with Relapsed or Refractory Follicular Lymphoma, Marginal Zone Lymphoma, CLL/SLL

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with follicular lymphoma, marginal zone lymphoma, and CLL/SLL. 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 FL, MZL, or CLL/SLL.
  • Prior treatment with at least 1 chemotherapy or immunotherapy-based regimen.
  • Detailed eligibility reviewed when you contact the study team.

Study Details 

This clinical trial is for men and women with relapsed/refractory FL, MZL, or CLL/SLL.

GS-9901 is a second generation inhibitor of PI3K-delta which is critical for multiple signaling pathways that are hyperactive in B-cell malignancies and inflammation. The first generation PI3K-delta inhibitor idelalisib has been shown to induce durable disease control in patients with B-cell malignancies. Idelalisib as monotherapy or in combination with other agents (such as bendamustine, chlorambucil) and immunotherapy (rituximab, ofatumumab) has been shown to be tolerable and demonstrated clinical efficacy in clinical trials in patients with iNHL, CLL, and other hematological malignancies. This study will provide more information about whether GS-9901 can benefit subjects with B-cell malignancies in terms of efficacy and tolerability compared to first generation PI3K inhibitors.

Subjects will receive GS-9901 continuously throughout the study as long as they are responding to therapy and not experiencing unacceptable side effects. GS-9901 is administered orally once daily. After discontinuing treatment, follow-up information will be collected once every year for up to 5 years at clinic visits or through telephone calls.

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