Feasibility and Efficacy of BACOPP-21 for Patients > 60 Years With Intermediate or Advanced Hodgkins Lymphoma

NCT ID: NCT00284271

Last Updated: 2011-07-29

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

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Brief Summary

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This study is designed to test (1) feasibility and efficiancy of new BACOPP regimen and (2) toxicity, overall response and FFTF.

Detailed Description

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Conditions

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Hodgkin´s Lymphoma

Keywords

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Hodgkin´s Lymphoma eldery patients primary diagnosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cyclophosphamide

Intervention Type DRUG

Adramycin

Intervention Type DRUG

Procarbacine

Intervention Type DRUG

Prednisone

Intervention Type DRUG

Vincristine

Intervention Type DRUG

Bleomycin

Intervention Type DRUG

Erythropoietin beta

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hodgkin´s lymphoma (histologically proven)
* CS (PS) I and II with one of the risk factors a-d

1. bulky mediastinal mass (\> 1/3 maximum transverse thorax diameter)
2. extranodal involvement
3. ESR \> 50 (A), \> 30 (B-symptoms)
4. 3 or more lymph node areas involved
* CS (PS) III and IV
* Written informed consent

Exclusion Criteria

* Leukocytes \<3000/microl
* Platelets \<100000/microl
* Hodgkin´s Disease as "composite lymphoma"
* Activity index (WHO) \< grade 2
Minimum Eligible Age

61 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Principal Investigators

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Andreas Josting, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

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University of Cologne

Cologne, , Germany

Site Status

Countries

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Germany

References

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Halbsguth TV, Nogova L, Mueller H, Sieniawski M, Eichenauer DA, Schober T, Nisters-Backes H, Borchmann P, Diehl V, Engert A, Josting A. Phase 2 study of BACOPP (bleomycin, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone) in older patients with Hodgkin lymphoma: a report from the German Hodgkin Study Group (GHSG). Blood. 2010 Sep 23;116(12):2026-32. doi: 10.1182/blood-2009-11-253211. Epub 2010 Jun 15.

Reference Type RESULT
PMID: 20551376 (View on PubMed)

Other Identifiers

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BACOPP-21

Identifier Type: -

Identifier Source: org_study_id