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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Lymphoma, B-Cell

Treatments: Drug: inotuzumab ozogamicin (CMC-544); Drug: rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00867087

B1931001 (Other Identifier)

2008-007802-12 (EudraCT Number)

3129K5-2005

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

64 participants in 1 patient group

Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2

Experimental group

Description:

Inotuzumab ozogamicin, in combination with rituximab, will be administered to patients with relapsed/refractory diffuse large B-cell Non-Hodgkin's lymphoma prior to an autologous stem cell transplant (aSCT).

Treatment:

Drug: inotuzumab ozogamicin (CMC-544)

Drug: rituximab