NCT00867087
Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin's Lymphoma
PHASE2
COMPLETED
NCT00867087
INTERVENTIONAL
An Open-label, Single-arm, Phase 2 Study Of Inotuzumab Ozogamicin Plus Rituximab In Subjects With Relapsed/Refractory Cd22-positive Diffuse Large B-cell Lymphoma, Eligible For Autologous Stem Cell Transplantation
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.
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
Lymphoma, B-Cell
- TREATMENT
-
- Type: DRUG
- Name: inotuzumab ozogamicin (CMC-544)
- Description: 1.8 mg/m\^2 every 21 days by intravenous infusion, 3 to 6 doses
- Arm Group Labels: Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2
-
- Type: DRUG
- Name: rituximab
- Description: 375 mg/m\^2 two days before cycle 1 by intravenous infusion; 375 mg/m\^2 every 21 days by intravenous infusion, 3 to 6 doses
- Arm Group Labels: Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2
- Pfizer