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STORM: Temsirolimus, Rituximab and DHAP for Relapsed and Refractory Diffuse Large B-cell Lymphoma

NCT01653067 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2016-10-27

No results posted yet for this study

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.

Conditions

  • Diffuse Large B-Cell Lymphoma

Interventions

DRUG

Rituximab, Temsirolimus, DHAP, intravenous

Maximum tolerated dose of Temsirolimus Rituximab (375 mg/m²) Dexamethasone (120 mg) Cisplatin (100mg/m²) Cytarabine (2x2g/m²))

Sponsors & Collaborators

  • Johannes Gutenberg University Mainz

    collaborator OTHER

  • Technical University of Munich

    collaborator OTHER

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • University Hospital Ulm

    collaborator OTHER

  • University Hospital Erlangen

    collaborator OTHER

  • Charite University, Berlin, Germany

    collaborator OTHER

  • University Hospital Freiburg

    collaborator OTHER

  • Johann Wolfgang Goethe University Hospital

    collaborator OTHER

  • Mathias Witzens-Harig

    lead OTHER

Principal Investigators

  • Mathias Witzens-Harig, MD · University Hospital of Heidelberg, Department 5 Hematology, Oncology, Rheumatology, Im Neuenheimer Feld 410, 69120 Heidelberg, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2018-06-30
Completion
2018-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01653067 on ClinicalTrials.gov