Escalating Doses of Torisel in Combination With Three Chemotherapies Regimens: R-CHOP, R-FC or R-DHA for Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL).

Complete Response Rate(CR) after 4 cycles and at the end of treatment

Response at the end of treatment will be assessed after four cycles and at the end of complete treatment if the patient received all planned cycles or at withdrawal. Patients without response assessments (due to whatever reason) will be considered non-responders. A descriptive analysis will also be performed considering as non-responders all patients who relapsed or died during the treatment phase even if they were prematurely withdrawn as responders.

Time frame: 28 days up to 42 days after the last treatment dose

Progression-free survival (PFS)

Progression-Free Survival will be measured from the date of inclusion to the date of first documented disease progression, relapse or death from any cause, according to the Cheson 2007 criteria. Responding patients and patients who are lost to follow up will be censored at their last tumor assessment date.

Time frame: From the date of inclusion to the date of first documentated disease progression, relapse or death from any cause up to 3 years

Duration of Response

Duration of response will be measured from the date of first documentation of a response (CR or PR at the end of treatment) to the date of first documented evidence of progression/relapse or death from any cause, according to the Cheson 2007 criteria. Responding patients and patients who are lost to follow up will be censored at their last tumor assessment date.

Time frame: From the date of first documentation of a response to the date of first documented evidence of progression/relapse or death from any cause up to 3 years

Overall Response at the end of treatment

The same disease response assessment used for complete response rate will be considered to determine the Overall Response Rate. A Patient will be defined as a responder if he/she has a complete response (CR/CRu) or partial response (PR) after four cycles and at the end of treatment. A descriptive analysis will also be performed considering as non-responders all patients who relapsed or died during treatment phase even if they were prematurely withdrawn as responders.

Time frame: 28 days up to 42 days after the last treatment dose

Overall Survival (OS)

Overall survival will be measured from the date of inclusion to the date of death from any cause. Patients who are alive at the time of analysis will be censored at the date of the last contact.

Time frame: From the date of inclusion to the date of first documentated disease progression, relapse or death from any cause up to 3 years

Safety of association Temsirolimus with the three chemotherapy regimens

All subjects who received at least one dose of Temsirolimus (Torisel™) will be considered evaluable and will be included in the safety analysis. Analysis of safety will be performed by summarizing adverse events, laboratory data, vital signs and ECOG per-formance status. When applicable, a summary of safety data will also be performed by cycle.

Time frame: From the date of informed consent signature to 28 days after the last drug administration