Phase 3
N=169
Study Evaluating Temsirolimus (CCI-779) In Mantle Cell Lymphoma (MCL)
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00117598 ↗Enrolled (actual)
169
Serious AEs
48.3%
Results posted
Mar 2012
Primary outcome: Primary: Progression-Free Survival (PFS) — 4.8; 3.7; 1.8 months — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Temsirolimus (CCI-779) (Drug); Investigator's choice (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Aug 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
4.8; 3.7; 1.8 | <0.0001 sig |
| SECONDARY Percentage of Participants With Objective Response |
22.2; 5.6; 1.9 | 0.0019 sig |
Summary
This is an open-label, randomized trial in relapsed refractory subjects with mantle cell lymphoma (MCL).
Eligibility Criteria
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.)
Data sourced from ClinicalTrials.gov (NCT00117598). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.