drugset / Trial / NCT00117598

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

Phase 3 Completed 169 enrolled Pfizer

RandomizedParallel-groupOpen-labelTreatment

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

Evaluation	Drug	Modality	Dose	Route
Comparator	Chlorambucil	Other / unclassified	0.1 mg/kg	Oral
Comparator	Chlorambucil	Other / unclassified	0.2 mg/kg	Oral
Comparator	Chlorambucil	Other / unclassified	0.3 mg/kg	Oral
Comparator	Chlorambucil	Other / unclassified	0.4 mg/kg	Oral
Comparator	Chlorambucil	Other / unclassified	0.8 mg/kg	Oral
Comparator	Cladribine	Small molecule	5 mg/m2	Intravenous
Comparator	Cyclophosphamide	Other / unclassified	200 mg/m2	Oral
Comparator	Cyclophosphamide	Other / unclassified	300 mg/m2	Oral
Comparator	Cyclophosphamide	Other / unclassified	400 mg/m2	Oral
Comparator	Cyclophosphamide	Other / unclassified	450 mg/m2	Oral
Comparator	Cyclophosphamide	Other / unclassified	600 mg/m2	Oral
Comparator	Cyclophosphamide	Other / unclassified	1200 mg/m2	Oral
Comparator	Dexamethasone	Small molecule	20 mg	Oral
Comparator	Dexamethasone	Small molecule	40 mg	Oral
Comparator	Etoposide	Small molecule	50 mg/m2	Intravenous
Comparator	Etoposide	Small molecule	100 mg/m2	Intravenous
Comparator	Etoposide	Small molecule	150 mg/m2	Intravenous
Comparator	Etoposide	Small molecule	300 mg/m2	Intravenous
Comparator	Fludarabine	Small molecule	25 mg/m2	Intravenous
Comparator	Gemcitabine	Small molecule	1 g	Intravenous
Comparator	Prednisone	Other / unclassified	20 mg/m2	Oral
Comparator	Prednisone	Other / unclassified	40 mg/m2	Oral
Comparator	Prednisone	Other / unclassified	60 mg/m2	Oral
Subject	Temsirolimus	Small molecule	25 mg	Intravenous
Subject	Temsirolimus	Small molecule	75 mg	Intravenous