The STORM-trial consists of two parts. In the part I (dose escalation of Temsirolimus) the primary objective is to establish a maximum tolerated dose of Temsirolimus in combination with Rituximab and DHAP. Secondary objective is to prove ability to mobilize stem cells in patients scheduled to high dose therapy. In the part II (full target dose) the primary objective is to evaluate the ORR in patients with relapsed diffuse large B cell lymphoma (DLBCL). The secondary objective is to evaluate progression free survival (PFS), overall survival (OS) and Toxicity.
This is a multicenter, open label, single arm, phase II study. There will be no placebo usage within this trial. In the part I, dose escalation part, of this trial 6 patients will be included in each dose level. There will be 4 cohorts, administering up to a maximum of 4 cycles 25 mg, 50 mg, 75mg or 100mg Temsirolimus in combination with Rituximab and DHAP. Treatment regimen part I: Part I - Cohort A, B, C, D, X Temsirolimus 25 (A), 50 (B), 75 (C),100 (D) or 15 (X) mg, Day 1, 8, Rituximab (375 mg/m² day 2) Dexamethasone 40mg day 3-6 Cisplatine 100 mg/m² day 3 Cytarabine 2x2 g/m² day 4 ...repeat day 22, up to a maximum of 4 cycles In part I, after inclusion of 6 patients, each patient has to receive at least 1 complete cycle w/o dose limiting toxicity until the enrollment into the next cohort can be initiated. In the part II of the trial 40 patients will be included to receive the full target dose, established within the part I of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Maximum tolerated dose of Temsirolimus Rituximab (375 mg/m²) Dexamethasone (120 mg) Cisplatin (100mg/m²) Cytarabine (2x2g/m²))
University Hospital Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
University of Heidelberg Hospital
Heidelberg, Baden-Wurttemberg, Germany
University Hospital Ulm
Ulm, Baden-Wurttemberg, Germany
University Hospital Erlangen
Erlangen, Bavaria, Germany
Ludwig-Maximilians-University of Munich
Munich, Bavaria, Germany
Technische Universität München
Munich, Bavaria, Germany
Johann Wolfgang Goethe University Hospitals, Frankfurt
Frankfurt am Main, Hesse, Germany
Johannes Guttenberg University Mainz
Mainz, Rhineland-Palatinate, Germany
Charité University Berlin
Berlin, State of Berlin, Germany
Safety, Tolerability and Efficacy of a combination therapy of Temsirolimus added to the standard therapy, Rituximab and DHAP (Cytarabine, Cisplatine, Dexamethasone)
In the part I (dose escalation of Temsirolimus) the primary objective is to establish a maximum tolerated dose of Temsirolimus in combination with Rituximab and DHAP.
Time frame: 09-2012 to 06-2018 (up to six years)
Safety, Tolerability and Efficacy of a combination therapy of Temsirolimus added to the standard therapy, Rituximab and DHAP (Cytarabine, Cisplatine, Dexamethasone)
In the part I (dose escalation of Temsirolimus) secondary objective is to prove ability to mobilize stem cells in patients scheduled to high dose therapy.
Time frame: 09-2012 to 06-2018 (up to six years)
Safety, Tolerability and Efficacy of a combination therapy of Temsirolimus added to the standard therapy, Rituximab and DHAP (Cytarabine, Cisplatine, Dexamethasone)
In the part II (full target dose) the secondary objective is to evaluate Progression Free Survival
Time frame: 09-2012 to 06-2018 (up to six years)
Safety, Tolerability and Efficacy of a combination therapy of Temsirolimus added to the standard therapy, Rituximab and DHAP (Cytarabine, Cisplatine, Dexamethasone)
In the part II (full target dose) the secondary objective is to evaluate Overall Survival
Time frame: 09-2012 to 06-2018 (up to six years)
Safety, Tolerability and Efficacy of a combination therapy of Temsirolimus added to the standard therapy, Rituximab and DHAP (Cytarabine, Cisplatine, Dexamethasone)
In the part II (full target dose) the secondary objective is to evaluate Toxicity
Time frame: 09-2012 to 06-2018 (up to six years)
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