Status:
COMPLETED
Study Evaluating The Safety And Tolerability Of Combination Therapy Inotuzumab Ozogamicin (CMC-544) And Rituximab
Lead Sponsor:
Pfizer
Conditions:
Lymphoma, B-Cell
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
Brief Summary
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).
Eligibility Criteria
Inclusion
- 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
- Candidate for potentially curative therapies
- Subjects must not have received previous radioimmunotherapy.
- Subjects with autologous hematopoietic stem cell transplant within the last 6 months
Key Trial Info
Start Date :
July 4 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00724971
Start Date
July 4 2008
End Date
March 10 2010
Last Update
March 15 2019
Active Locations (4)
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1
Nagoya Daini Red Cross Hospital
Aichi, Japan, 466-8650
2
Tokai University Hospital
Kanagawa, Japan, 259-1193
3
National Cancer Center Hospital
Tokyo, Japan, 104-0045
4
Cancer Inst. Hp. of Japanese Foundation for Cancer Research
Tokyo, Japan, 135-8550