Study Evaluating The Safety And Tolerability Of Combination Therapy Inotuzumab Ozogamicin (CMC-544) And Rituximab

Pfizer

Status and phase: Completed; Phase 1

Conditions: Lymphoma, B-Cell

Treatments: Drug: Rituximab (Rituxan); Drug: Inotuzumab Ozogamicin (CMC-544)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00724971

B1931005 (Other Identifier)

3129K3-1104

Details and patient eligibility

About

To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in combination with Rituximab in patients with B-Cell Non-Hodgkin's lymphoma (NHL).

Enrollment: 10 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CD20 and CD22-positive, B-cell NHL which has progressed after 1 or 2 prior therapies.
• Prior therapy must have contained at least one dose of Rituximab therapy. Patients can not be refractory to Rituximab (refractory = PD under treatment or within 6 month
• Eastern Cooperative Oncology Group (ECOG) performance status: 0/ 1.
• Patients must not have received previous radioimmunotherapy.
• Patients tolerant to Rituximab.
• Patients must not have received chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents within 28 days before first dose of test article.

Exclusion criteria

• Candidate for potentially curative therapies
• Subjects must not have received previous radioimmunotherapy.
• Subjects with autologous hematopoietic stem cell transplant within the last 6 months

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Inotuzumab Ozogamicin + Rituximab

Experimental group

Treatment:

Drug: Inotuzumab Ozogamicin (CMC-544)

Drug: Rituximab (Rituxan)