Study Evaluating CMC-544 In B-Cell Non-Hodgkin's Lymphoma
NCT00073749
ABOUT THIS STUDY
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- Subjects who have been previously diagnosed with CD22-positive, B-cell NHL, according to WHO classification, which has progressed after at least 2 prior therapies of probable clinical benefit
- At the expanded cohort, part 2 of the study, subjects must have one of the following:
- Follicular lymphoma previously treated with at least one dose of rituximab, but have not received radioimmunotherapy
- Diffuse large B-cell lymphoma
- Age 18 years or older
- Candidate for potentially curative therapies in the opinion of the investigator
- Chronic lymphocytic leukemia
- Burkitt's lymphoma, primary effusion lymphoma, and precursor B-cell lymphoblastic
lymphoma
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating CMC-544 In B-Cell Non-Hodgkin's Lymphoma | |||
Official Title ICMJE | A Phase 1 Study Of Cmc-544 Administered As A Single Agent In Subjects With B-cell Non- Hodgkin's Lymphoma | |||
Brief Summary | To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Lymphoma, B-Cell | |||
Intervention ICMJE | Drug: Inotuzumab ozogamicin [CMC-544]
CMC-544, IV, dose escalation trial | |||
Study Arms ICMJE | Experimental: Inotuzumab ozogamicin
Inotuzumab ozogamicin, iv, dose escalation and expanded cohort at 1.8mg/m2 Intervention: Drug: Inotuzumab ozogamicin [CMC-544] | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 79 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | December 2010 | |||
Actual Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 99 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, France, Germany, Spain, Switzerland, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00073749 | |||
Other Study ID Numbers ICMJE | 3129K1-100 B1931002 ( Other Identifier: Alias Study Number ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | December 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |