A Randomised Double Blind Phase II Trial to Evaluate the Efficacy of Two Doses of Fostamatinib in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women with diffuse large B-cell lymphoma (DLBCL) that has either come back after therapy or did not respond to therapy (relapsed/refractory DLBCL).

The purpose of this study is to determine the effectiveness of treating DLBCL with 2 different doses of the experimental drug fostamatinib. The study will also evaluate the side effects of fostamatinib when used to treat DLBCL.

Fostamatinib inhibits an enzyme called spleen tyrosine kinase (Syk). Lymphoma cell multiplication and survival is linked to this enzyme. It is possible that by inhibiting the Syk enzyme, fostamatinib may inhibit and eliminate lymphoma cells.

All study participants will receive fostamatinib; there is no placebo. Study participants will be randomly assigned to one of the following dosing groups:

  • Group 1: Fostamatinib 100 mg twice daily
  • Group 2: Fostamatinib 200 mg twice daily

Fostamatinib is a pill taken by mouth once in the morning and once in the evening.

Study participants may continue with fostamatinib treatment as long as they are receiving benefit and do not experience unacceptable side effects.

Disease Status and/or Stage

Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Sponsor

AstraZeneca

Key Eligibility

  • Men and women age 18 and older
  • Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
  • Have previously received R-CHOP (or equivalent) chemo-immunotherapy and high-dose chemotherapy with stem-cell rescue, or are ineligible for high-dose chemotherapy with stem-cell rescue
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Jia Ruan, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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