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2006-1B / ACT-2 – Alemtuzumab and CHOP in T-Cell Lymphoma (elderly patients)

General information and documents for the clinical trial DSHNHL 2006-1B / ACT-2.
This randomized phase III trial will evaluate the efficacy of chemoimmunotherapy with the monoclonal antibody Campath-1H (Alemtuzumab) given in combination with 6 courses of 2-weekly CHOP, versus standard chemotherapy with 2-weekly CHOP alone. This protocol is open to elderly patients (>60 years) with previously untreated systemic peripheral T-cell lymphomas. This study is designed to recruit a total of 274 patients from October 2007 through October 2011, and has been activated in several German as well international clinical centers.

General Information

  • Synopsis
  • Responsible persons and institutions
  • Participating Groups or Countries
  • Contact information
  • Randomisation on Holidays

Publicly available documents

  • PDF Synopsis (63 kB)
  • PDF Flowsheet (16 kB)

Password protected documents

  • PDF Protocol DSHNHL 2006-1B / ACT-2 (590 kB, 73 pages)
  • PDF CRF Handling Guideline I: Randomisation Procedure (64 kB, 8 pages)
  • PDF CRF Handling Guideline II: Documentation and Transmission (85 kB, 12 pages)
  • PDF CRF Handling Guideline III: Documentation of Serious Adverse Events (SAEs) (46 kB, 6 pages)

 

The following documents are to be used for patients who are treated within the framework of "Integrierte Versorgung" as "Nicht-Studien-Patienten" :

PDF Aufnahmebogen Nicht-Studienpatienten (60 kB, German, 1 page)

PDF Therapiebogen Nicht-Studienpatienten (28 kB, German, 1 page)

PDF Nachsorgebogen Nicht-Studienpatienten (28 kB, German, 1 page)

 

 

 

 


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