Overview

This trial is active, not recruiting.

Condition hodgkin lymphoma
Treatments etoposide, cyclophosphamide, doxorubicin, prednisone, procarbazine, dexamethasone, dacarbazine, brentuximab vedotin
Phase phase 2
Sponsor University of Cologne
Start date October 2012
End date March 2014
Trial size 100 participants
Trial identifier NCT01569204, Targeted BEACOPP

Summary

The Purpose of this trial is:

- to determine complete response rate (CRR) after six cycles of chemotherapy

- to determine complete remission rate (CR/CRr) as final treatment outcome after completion of treatment

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin
etoposide
cyclophosphamide
doxorubicin
prednisone
procarbazine
brentuximab vedotin
(Active Comparator)
modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone
etoposide
cyclophosphamide
doxorubicin
dexamethasone
dacarbazine
brentuximab vedotin

Primary Outcomes

Measure
Response rate (RR) after six cycles of chemotherapy
time frame: 18 weeks
Complete remission rate (CR/CRr) as final treatment outcome after completion of treatment
time frame: 18 weeks

Secondary Outcomes

Measure
Progression Free Survival (PFS)
time frame: 2 years
Overall survival (OS)
time frame: 2 years
Adverse event rate
time frame: 2 years
Dose reduction rate
time frame: 18 weeks
Relative dose intensity
time frame: 18 weeks

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: - Histologically proven classical Hodgkin lymphoma - First diagnosis, no previous treatment, age: 18-60 years - Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV disease Exclusion Criteria: - Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL) - Previous malignancy - Prior chemotherapy or radiation

Additional Information

Principal investigator Peter Borchmann, Prof.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of Cologne.