Patients with refractory and recidivated primary CNS lymphoma
Conditions
Interventions
Trade Name: Torisel
Product Name: Temsirolimus
Pharmaceutical Form: Concentrate and solvent for solution for injection
Sponsors
Charité - University Hospital of Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Primary CNS lymphoma diagnosed histologically or by cerebrospinal fluid cytology; absence of systemic lymphoma manifestaions - Relapse or lymphoma progression after/during high-dose methotrexate containing first-line chemotherapy or alternative therapy in the case of contraindications against high-dose methotrexate - ECOG performance score = 2 - Age =18 and = 75 years - Life expectancy of at least 3 months - Absence of active infection - Negative HIV serology - Adequate renal function (GFR >30ml/min) - Adequate bone marrow resere (neutrophils > 1500/µl, platelets > 80,000/µl) - Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range ;Inclusion criteria: - Primary CNS lymphoma diagnosed histologically or by cerebrospinal fluid cytology; absence of systemic lymphoma manifestaions - Relapse or lymphoma progression after/during high-dose methotrexate containing first-line chemotherapy or alternative therapy in the case of contraindications against high-dose methotrexate - ECOG performance score = 2 - Age =18 and = 75 years - Life expectancy of at least 3 months - Absence of active infection - Negative HIV serology - Adequate renal function (GFR >30ml/min) - Adequate bone marrow resere (neutrophils > 1500/µl, platelets > 80,000/µl) - Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Secundary CNS lymphoma - Primary intraocular lymphoma - Concurrent treatment within another clinical trial - Patients who are suitable for high-dose chemotherapy with autologous stem cell transplantation - Concurrent other malignant disease - Symptomatic congestive heart failure (=NYHA II) - Active or uncontrolled chronic infection - Severe concomitant disease incompatible with study conduct - History of cerebral bleeding - Concomitant treatment with strong CYP3A4/5-inductors or –inhibitors - Premenopausal women without highly effective contraception (defined as Pearl index <1) - Pregnant or lactating women - Refusal to record and pass on pseudonymized disease and treatment related data as part of the treatment protocol - Subjects who are legally detained in an official institute ;Exclusion criteria: - Secundary CNS lymphoma - Primary intraocular lymphoma - Concurrent treatment within another clinical trial - Patients who are suitable for high-dose chemotherapy with autologous stem cell transplantation - Concurrent other malignant disease - Symptomatic congestive heart failure (=NYHA II) - Active or uncontrolled chronic infection - Severe concomitant disease incompatible with study conduct - History of cerebral bleeding - Concomitant treatment with strong CYP3A4/5-inductors or –inhibitors - Premenopausal women without highly effective contraception (defined as Pearl index <1) - Pregnant or lactating women - Refusal to record and pass on pseudonymized disease and treatment related data as part of the treatment protocol - Subjects who are legally detained in an official institute
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to assess efficacy of Temsirolimus in patients with refractory and recidivated primary CNS lymphoma;Secondary Objective: ;Primary end point(s): Overall response rate (partial or complete remission) ;Main Objective: The objective of this study is to assess efficacy of Temsirolimus in patients with refractory and recidivated primary CNS lymphoma;Secondary Objective: ;Primary end point(s): Overall response rate (partial or complete remission) | — |
Countries
Germany
Contacts
Public Contact; ;
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Outcome results
None listed