Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2012-10-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate inotuzumab ozogamicin in combination with rituximab prior to an autologous stem cell transplant (aSCT) in patients with relapsed/refractory diffuse large B-cell Non-Hodgkin's lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Collaborator: UCB Pharma
• Treatments: Inotuzumab Ozogamicin; Rituximab

Criteria

Inclusion Criteria:

• CD20/CD22-positive diffuse large B-cell NHL that has relapsed after 1 or 2 prior therapies; one prior therapy must include anthracyclines and one must include rituximab in combination with chemotherapy

• Relapsed/disease progression within 12 months after start of prior therapy and/or secondary International Prognostic Index (sIPI) score greater than 1

• Eligible for autologous stem cell transplant (aSCT)

Exclusion Criteria:

• Prior allogeneic hematopoietic stem cell transplant

• Within 6 months prior to test article: autologous transplant, treatment with anti-CD22 antibodies, radio-immunotherapy

• Veno-occlusive disease or sinusoidal obstruction syndrome, chronic liver disease, systemic vasculitides, current or chronic hepatitis B or C infection