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OpenTrials
Completed

NCT Number: NCT01569204

Targeted BEACOPP Variants in Patients With Newly Diagnosed Advanced Classical Hodgkin Lymphoma

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

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Key information

Conditions

Hodgkin Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1st Dept. of Medicine, Cologne University Hospital

Cologne, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etoposide

Drug

Cyclophosphamide

Drug

Doxorubicin

Drug

Prednisone

Drug

Procarbazine

Drug

Dexamethasone

Drug

Dacarbazine

Drug

Brentuximab Vedotin

Drug

Primary outcomes

  1. Response rate (RR) after six cycles of chemotherapy

    Time frame: 18 weeks

  2. Complete remission rate (CR/CRr) as final treatment outcome after completion of treatment

    Time frame: 18 weeks

Secondary outcomes

  1. Progression Free Survival (PFS)

    Time frame: 2 years

  2. Overall survival (OS)

    Time frame: 2 years

  3. Adverse event rate

    Time frame: 2 years

  4. Dose reduction rate

    Time frame: 18 weeks

  5. Relative dose intensity

    Time frame: 18 weeks

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2017
First posted
Apr 3, 2012
Registry last updated
Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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