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Alemtuzumab and CHOP in T-cell Lymphoma

NCT00646854 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2019-03-01

No results posted yet for this study

Summary

The purpose of this study is to determine efficacy and safety of the monoclonal antibody MabCampath® (alemtuzumab) combined with chemotherapy in the treatment of T-cell lymphoma.

Conditions

  • Lymphoma, T-Cell, Peripheral

Interventions

DRUG

CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumab

Cyclophosphamide 750 mg/m2 i.v. on day 1 Hydroxydaunorubicin 50 mg/m2 i.v. on day 1 Vincristin 1 mg/m2 i.v. day 1 (max. 2mg) Prednisone 50 mg/m2 p.o. day 1 to 5 Alemtuzumab 30 mg s.c.on day 1 of CHOP-14 cycles 1-4

DRUG

CHOP14 chemotherapy (see specification under Arm B) plus G-CSF

6 cycles of CHOP every 2 weeks

Sponsors & Collaborators

  • GCP-unit at Aarhus University Hospital, Aarhus, Denmark

    collaborator OTHER

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Francesco d'Amore, Prof · Dept. of Hematology, Århus University Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Sweden

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 NCT00646854 on ClinicalTrials.gov