Status:
COMPLETED
Study Evaluating Temsirolimus (CCI-779) In Mantle Cell Lymphoma (MCL)
Lead Sponsor:
Pfizer
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is an open-label, randomized trial in relapsed refractory subjects with mantle cell lymphoma (MCL).
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.)
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT00117598
Start Date
May 1 2005
End Date
January 1 2011
Last Update
March 30 2015
Active Locations (73)
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1
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
2
Pfizer Investigational Site
Fountain Valley, California, United States, 92708
3
Pfizer Investigational Site
Los Angeles, California, United States, 90024-2828
4
Pfizer Investigational Site
New Milford, Connecticut, United States, 06776