Clinical Trials

A Phase III Study of Inotuzumab Ozogamicin with Rituximab versus Standard Therapy for Patients with Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma

Protocol
12-005
Full Title
An Open-label, Randomized, Phase 3 Study of Inotuzumab Ozogamicin Administered in Combination With Rituximab Compared to Defined Investigator's Choice Therapy in Subjects With Relapsed or Refractory CD22-Positive Aggressive Non-Hodgkin Lymphoma Who are Not Candidates for Intensive High-Dose Chemotherapy
Purpose

This study is comparing therapy with an investigational drug called inotuzumab ozogamicin, given in combination with rituximab (an approved drug), to treat patients with aggressive non-Hodgkin lymphoma (NHL) that has returned despite or stopped responding to other therapies. Patients in this study are not candidates for intensive high-dose chemotherapy because of their age or current health status.

Inotuzumab ozogamicin is an antibody that targets a protein on NHL cells called CD22. The antibody is attached to a toxin called calicheamicin that can enter and kill NHL cells. Patients in this study will be randomly assigned to receive inotuzumab plus rituximab (the latter drug being a standard therapy for NHL) or one of two standard treatment regimens (rituximab/bendamustine or rituximab/gemcitabine).

Investigator
Paul A. Hamlin, MD -- Clinical Director, Lymphoma Outpatient Unit
Paul A. Hamlin - Physician Profile
Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have aggressive NHL that has returned despite or has stopped responding to standard therapies that included rituximab.
  • Patients’ tumors must be positive for the CD20 protein (the target of rituximab) and CD22 (the target of inotuzumab).
  • Patients may not be candidates for intensive high-dose chemotherapy.
  • Patients may not have received prior therapy with anti-CD22 antibodies or radioimmunotherapy or a transplant of stem cells from a donor.
  • At least 4 weeks must have passed since completion of prior treatment and entry into the study.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Paul A. Hamlin at 212-639-6143.

Disease(s)
Lymphoma
Lymphoma: Non-Hodgkin's Lymphoma
Locations
ClinicalTrials.gov
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