Study Evaluating Temsirolimus (CCI-779) In Mantle Cell Lymphoma (MCL)
NCT00117598
ABOUT THIS STUDY
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- Mantle cell lymphoma (MCL) confirmed with histology, immunophenotype, and cyclin D1 analysis
- Received 2 to 7 prior therapies which may include hematopoietic stem cell transplant (i.e. induction + consolidation + maintenance)
- Prior treatment with an alkylating agent and an anthracycline, rituximab, individually or in combination, and status that is at least one of the following:
- Primary disease refractory to at least 2 regimens;
- Refractory to at least 1 regimen after first relapse;
- Refractory or untreated after second or greater relapse;
- Refractory to first line and relapsed after second line. Chemotherapy combinations may include, but are not limited to: CHOP (Cyclophosphamide, doxorubicin, vincristine, prednisone), R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine, prednisone), FCM (Fludarabine, cyclophosphamide, mitoxantrone), R-FCM (Rituximab,Fludarabine, cyclophosphamide, mitoxantrone), ICE(Ifosfamide, carboplatin, etoposide), DHAP (Dexamethasone, cisplatin, cytarabine) and hyper-CVAD (Cyclophosphamide, doxorubicin, vincristine, dexamethasone).
- Subjects who are less than or equal to six month from allogeneic hematopoietic stem
cell transplant and who are on immunosuppressive therapy or have evidence of graft
versus host disease
- Prior investigational therapy within 3 weeks of first dose. Investigational therapy is
defined as treatment that is not approved for any indication.
- Active central nervous system (CNS) metastases, as indicated by clinical symptoms,
cerebral edema, requirement for corticosteroids and/or progressive growth. (Treated
CNS metastases must be stable for > 2 weeks prior to Day 1.)
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating Temsirolimus (CCI-779) In Mantle Cell Lymphoma (MCL) | |||
Official Title ICMJE | An Open-Label, Randomized, Phase 3 Trial Of Intravenous Temsirolimus (CCI-779) At Two Dose Levels Compared To Investigator's Choice Therapy In Relapsed, Refractory Subjects With Mantle Cell Lymphoma (MCL) | |||
Brief Summary | This is an open-label, randomized trial in relapsed refractory subjects with mantle cell lymphoma (MCL). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Lymphoma | |||
Intervention ICMJE |
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Study Arms ICMJE |
| |||
Publications * | Hess G, Coiffier B, Crump M, Gisselbrecht C, Offner F, Romaguera J, Kang L, Moran PJ. Effect of prognostic classification on temsirolimus efficacy and safety in patients with relapsed or refractory mantle cell lymphoma: a retrospective analysis. Exp Hematol Oncol. 2015 Apr 11;4:11. doi: 10.1186/s40164-015-0006-1. eCollection 2015. | |||
* 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 | 169 | |||
Original Enrollment ICMJE | 177 | |||
Actual Study Completion Date ICMJE | January 2011 | |||
Actual Primary Completion Date | August 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
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 | Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00117598 | |||
Other Study ID Numbers ICMJE | 3066K1-305 | |||
Has Data Monitoring Committee | Yes | |||
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 | March 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |