Study Evaluating Temsirolimus (CCI-779) In Mantle Cell Lymphoma (MCL)

Completed · Phase 3

Conditions studied: Lymphoma

In brief

This is an open-label, randomized trial in relapsed refractory subjects with mantle cell lymphoma (MCL).

Key facts

Study ID

NCT00117598

Run by

Pfizer

People needed

169

Starts

2005-05-01

Expected to finish

2011-01-01

Last updated by the study team

2015-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.)

Where it is running

• Pfizer Investigational Site — Fountain Valley, California, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — New Milford, Connecticut, United States
• Pfizer Investigational Site — Washington D.C., District of Columbia, United States
• Pfizer Investigational Site — Boca Raton, Florida, United States
• Pfizer Investigational Site — Honolulu, Hawaii, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Morristown, New Jersey, United States
• Pfizer Investigational Site — Buffalo, New York, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Rochester, New York, United States
• Pfizer Investigational Site — Portland, Oregon, United States
• Pfizer Investigational Site — Upland, Pennsylvania, United States
• Pfizer Investigational Site — Austin, Texas, United States
• Pfizer Investigational Site — Grapevine, Texas, United States
• Pfizer Investigational Site — Houston, Texas, United States
• Pfizer Investigational Site — Temple, Texas, United States
• Pfizer Investigational Site — Seattle, Washington, United States
• Pfizer Investigational Site — Buenos Aires, Buenos Aires, Argentina
• Pfizer Investigational Site — Córdoba, Córdoba Province, Argentina
• Pfizer Investigational Site — Buenos Aires, Argentina
• Pfizer Investigational Site — East Melbourne, Victoria, Australia
• Pfizer Investigational Site — Vienna, Austria
• Pfizer Investigational Site — Ghent, Belgium, Belgium
• Pfizer Investigational Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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