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

Pfizer

Status and phase

Completed

Phase 3

Conditions

Lymphoma

Treatments

Drug: Temsirolimus (CCI-779)

Drug: Investigator's choice

Study type

Interventional

Funder types

Industry

Identifiers

3066K1-305

Details and patient eligibility

About

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

Enrollment

169 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.)