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

NCT ID: NCT01569204

Last Updated: 2018-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2017-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Hodgkin Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BrECAPP

modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin

Group Type ACTIVE_COMPARATOR

Etoposide

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Doxorubicin

Intervention Type DRUG

Prednisone

Intervention Type DRUG

Procarbazine

Intervention Type DRUG

Brentuximab Vedotin

Intervention Type DRUG

BrECADD

modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone

Group Type ACTIVE_COMPARATOR

Etoposide

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Doxorubicin

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Dacarbazine

Intervention Type DRUG

Brentuximab Vedotin

Intervention Type DRUG

Interventions

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Etoposide

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Doxorubicin

Intervention Type DRUG

Prednisone

Intervention Type DRUG

Procarbazine

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Dacarbazine

Intervention Type DRUG

Brentuximab Vedotin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Peter Borchmann

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Borchmann, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Cologne, German Hodgkin Study Group

Locations

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1st Dept. of Medicine, Cologne University Hospital

Cologne, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.ghsg.org

Homepage GHSG

Other Identifiers

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Targeted BEACOPP

Identifier Type: -

Identifier Source: org_study_id

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