Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subjects With Non-Hodgkin's Lymphoma (NHL)
NCT00299494
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- Subjects with CD20 and CD22-positive, follicular or diffuse large B-cell NHL who have not responded or progressed after 1 or 2 prior therapies; or subjects with CD20 and CD22-positive intermediate/aggressive NHL (diffuse large B-cell, mantle cell, transformed follicular or follicular grade 3b NHL) who have not responded or progressed after 1 or more prior therapies and are refractory to a previous rituximab containing therapy.
- Prior therapy must contain at least one course of rituximab therapy, as single agent or in combination.
- Measurable disease.
- Subjects who are candidates for other potentially curative therapies.
- Subjects must not have received previous radioimmunotherapy.
- Subjects who have undergone a prior bone marrow transplantation within the last 6
months.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subjects With Non-Hodgkin's Lymphoma (NHL) | |||
Official Title ICMJE | A Phase 1/2 Study Of Cmc-544 Administered In Combination With Rituximab In Subjects With Follicular Or Diffuse Large B-cell Non-hodgkin's Lymphoma | |||
Brief Summary | The purpose of the study is to determine the tolerability, the initial safety profile and maximum tolerated dose, and to obtain preliminary information on the antitumor activity of inotuzumab ozogamicin [CMC-544] in combination with rituximab in subjects with follicular, diffuse large B-Cell, or mantle cell NHL. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Factorial Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | B-Cell Lymphoma | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Fayad L, Offner F, Smith MR, Verhoef G, Johnson P, Kaufman JL, Rohatiner A, Advani A, Foran J, Hess G, Coiffier B, Czuczman M, Giné E, Durrant S, Kneissl M, Luu KT, Hua SY, Boni J, Vandendries E, Dang NH. Safety and clinical activity of a combination therapy comprising two antibody-based targeting agents for the treatment of non-Hodgkin lymphoma: results of a phase I/II study evaluating the immunoconjugate inotuzumab ozogamicin with rituximab. J Clin Oncol. 2013 Feb 10;31(5):573-83. doi: 10.1200/JCO.2012.42.7211. Epub 2013 Jan 7. | |||
* 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 | 119 | |||
Original Enrollment ICMJE | 100 | |||
Actual Study Completion Date ICMJE | June 2, 2014 | |||
Actual Primary Completion Date | May 19, 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (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 | Australia, Belgium, France, Germany, Hong Kong, Italy, Korea, Republic of, Netherlands, Poland, Spain, Switzerland, United Kingdom, United States | |||
Removed Location Countries | Singapore | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00299494 | |||
Other Study ID Numbers ICMJE | 3129K3-101 B1931004 ( Other Identifier: Alias Study Number ) 2005-005436-27 ( EudraCT 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 | UCB Pharma | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | February 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |