Back to resultsStudy Evaluating Safety and Tolerability of Inotuzumab Ozogamicin (CMC-544) in Japanese Patients With B-cell Non-Hodgkin's Lymphoma (NHL)
Primary Purpose
Lymphoma, B-Cell
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Inotuzumab Ozogamicin (CMC-544)
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, B-Cell focused on measuring B-cell Non-Hodgkin's Lymphoma, NHL
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Incidence and severity of adverse events, dose-limiting toxicities, and changes in laboratory test results.
Secondary Outcome Measures
Tumor response (according to the International Response Criteria for Non-Hodgkin's Lymphomas).
Full Information
NCT ID
NCT00717925
First Posted
July 16, 2008
Last Updated
December 7, 2015
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00717925
Brief Title
Study Evaluating Safety and Tolerability of Inotuzumab Ozogamicin (CMC-544) in Japanese Patients With B-cell Non-Hodgkin's Lymphoma (NHL)
Official Title
A Phase 1 Study Of CMC-544 Administered As A Single Agent In Subjects With B-Cell Non-Hodgkin's Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, B-Cell
Keywords
B-cell Non-Hodgkin's Lymphoma, NHL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Inotuzumab Ozogamicin (CMC-544)
Intervention Description
Intravenous (IV) infusion, 1.3 - 1.8 mg/m2, every 28 days, 4 cycles
Primary Outcome Measure Information:
Title
Incidence and severity of adverse events, dose-limiting toxicities, and changes in laboratory test results.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Tumor response (according to the International Response Criteria for Non-Hodgkin's Lymphomas).
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
20491780
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3129K1-103
Description
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Learn more about this trial
Study Evaluating Safety and Tolerability of Inotuzumab Ozogamicin (CMC-544) in Japanese Patients With B-cell Non-Hodgkin's Lymphoma (NHL)
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