drugset / Trial / NCT01653067
STORM: Temsirolimus, Rituximab and DHAP for Relapsed and Refractory Diffuse Large B-cell Lymphoma
Phase 2
Unknown
88 enrolled
Mathias Witzens-Harig
Charite University, Berlin, Germany · collabJohann Wolfgang Goethe University Hospital · collabJohannes Gutenberg University Mainz · collabLudwig-Maximilians - University of Munich · collabTechnical University of Munich · collabUniversity Hospital Erlangen · collabUniversity Hospital Freiburg · collabUniversity Hospital Ulm · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2012-09
- Primary completion
- 2018-06
- Completion
- 2018-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Temsirolimus | Small molecule | 15 mg | Intravenous |
| Subject | Temsirolimus | Small molecule | 25 mg | Intravenous |
| Subject | Temsirolimus | Small molecule | 50 mg | Intravenous |
| Subject | Temsirolimus | Small molecule | 75 mg | Intravenous |
| Subject | Temsirolimus | Small molecule | 100 mg | Intravenous |
| Background | Cisplatin | Other / unclassified | 100 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | 2 g | Intravenous |
| Background | Dexamethasone | Small molecule | 40 mg | Intravenous |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |