A Phase II Trial to Evaluate the Safety, Feasibility and Efficacy of a Salvage Therapy Consisting of Temsirolimus Added to the Standard Therapy R-DHAP for the Treatment of Patients With Relapsed or Refractory DLBCL - the STORM Trial
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
09-2012 to 06-2018 (up to six years)
Mathias Witzens-Harig, MD
University Hospital of Heidelberg, Department 5 Hematology, Oncology, Rheumatology, Im Neuenheimer Feld 410, 69120 Heidelberg, Germany
Germany: Ethics Commission