Study Evaluating Safety and Tolerability of Inotuzumab Ozogamicin (CMC-544) in Japanese Patients With B-cell Non-Hodgkin's Lymphoma (NHL)
A Phase 1 Study Of CMC-544 Administered As A Single Agent In Subjects With B-Cell Non-Hodgkin's Lymphoma
1 other identifier
interventional
13
0 countries
N/A
Brief Summary
To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in patients with B-Cell Non-Hodgkin's Lymphoma (NHL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2007
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 16, 2008
CompletedFirst Posted
Study publicly available on registry
July 18, 2008
CompletedDecember 9, 2015
December 1, 2015
1.3 years
July 16, 2008
December 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and severity of adverse events, dose-limiting toxicities, and changes in laboratory test results.
4 months
Secondary Outcomes (1)
Tumor response (according to the International Response Criteria for Non-Hodgkin's Lymphomas).
4 months
Study Arms (1)
1
EXPERIMENTALInterventions
Intravenous (IV) infusion, 1.3 - 1.8 mg/m2, every 28 days, 4 cycles
Eligibility Criteria
You may qualify if:
- CD22-positive, B-cell NHL which has progressed after 1 or 2 prior therapies.
- Patients who have progressed after at least 1 prior chemotherapy regimen for indolent lymphoma, or 1/ 2 chemotherapy regimens, which include anthracylin or anthraquinon for aggressive lymphoma.
- Eastern Cooperative Oncology Group (ECOG) performance status: 0/ 1.
You may not qualify if:
- Patients must not have received monoclonal antibodies or radioimmunoconjugates within 3 months before first dose of test article.
- Patients must not have received bilateral pelvic irradiation.
- Patients must not have received chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents within 4 weeks before first dose of test article.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Ogura M, Tobinai K, Hatake K, Uchida T, Kasai M, Oyama T, Suzuki T, Kobayashi Y, Watanabe T, Azuma T, Mori M, Terui Y, Yokoyama M, Mishima Y, Takahashi S, Ono C, Ohata J. Phase I study of inotuzumab ozogamicin (CMC-544) in Japanese patients with follicular lymphoma pretreated with rituximab-based therapy. Cancer Sci. 2010 Aug;101(8):1840-5. doi: 10.1111/j.1349-7006.2010.01601.x. Epub 2010 Apr 23.
PMID: 20491780DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 16, 2008
First Posted
July 18, 2008
Study Start
March 1, 2007
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
December 9, 2015
Record last verified: 2015-12