Kurzfassung

A phase II trial to evaluate the safety, feasibility and efficacy of a salvage therapy
consisting of the mTOR inhibitor Temsirolimus (Torisel) added to the standard therapy
of Rituximab and DHAP for the treatment of patients with relapsed or refractory diffuse
large cell B-Cell lymphoma – the STORM trial

This is a multicenter, open label, single arm, phase II study. There will be no placebo
usage within this trial. In part I, dose escalation part, of this trial 6 patients will be
included in each...A phase II trial to evaluate the safety, feasibility and efficacy of a salvage therapy
consisting of the mTOR inhibitor Temsirolimus (Torisel™) added to the standard therapy
of Rituximab and DHAP for the treatment of patients with relapsed or refractory diffuse
large cell B-Cell lymphoma – the STORM trial

This is a multicenter, open label, single arm, phase II study. There will be no placebo
usage within this trial. In 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.
In part II of the trial 40 patients will be included to receive the full target dose,
established within the part I of the study.

In 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 part II (full target dose) the primary objective is to evaluate the ORR in patients
with relapsed DLBCL. The secondary objective is to evaluate PFS, OS and Toxicity

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