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)

CompletadoFase 3ClinicalTrials.gov

ID: NCT00117598Tipo: INTERVENTIONALInicio: 1 de may de 2005Fin estimado: 1 de ene de 2011

Oncología

Traducción no disponible, mostrando original

Resumen

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

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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).

Criterios de exclusión

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.)

Intervenciones

drug

Temsirolimus (CCI-779)

Temsirolimus 175 mg IV once a week for 3 weeks; followed by 75 mg IV once a week

drug

Temsirolimus (CCI-779)

Temsirolimus 175 mg IV once a week for 3 weeks; followed by 25 mg IV once a week

drug

Investigator's choice

Any of the following single agent treatments: 1. Fludarabine 25 mg/m2 IV over 30 minutes daily for 5 consecutive days, every 28 days or oral administration, as appropriate. 2. Chlorambucil 0.1 (0.1-0.2) mg/kg PO daily for 3 to 6 weeks as required OR 0.4 (0.3 0.8) mg/kg PO every 21 to 28 days 3. Gemcitabine 1 gm/m2 IV over 30 minutes on days 1, 8 and 15 every 28 days or day 1 and day 8 every 21 days 4. Cyclophosphamide 300 (200-450) mg/m2 PO daily for 5 consecutive days every 21 to 28 days, OR 600 (400-1200) mg/m2 IV every 21 to 28 days 5. Cladribine 5 mg/m2 IV daily for 5 consecutive days, every 28 days for 2-6 cycles depending on response, 6. Etoposide 50 (50-150) mg/m2 IV daily for 3-5 days every 21 to 28 days OR 100 (50 300) mg/m2 PO daily for 3-5 days every 21 to 28 days 7. Prednisone 40 (20-60) mg/m2 PO daily or every other day 8. Dexamethasone 20(20-40) mg PO/IV daily for 5 consecutive days, every 14 - 28 day

Ubicaciones

Pfizer Investigational Site

Buenos Aires, Buenos Aires, Argentina

Pfizer Investigational Site

Córdoba, Córdoba Province, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Patrocinadores

PrincipalPfizer

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