NCT00284271

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2006

Completed
Last Updated

July 29, 2011

Status Verified

July 1, 2011

Enrollment Period

1.9 years

First QC Date

January 27, 2006

Last Update Submit

July 28, 2011

Conditions

Hodgkin´s Lymphoma

Keywords

Hodgkin´s Lymphomaeldery patientsprimary diagnosis

Interventions

CyclophosphamideDRUG
AdramycinDRUG
ProcarbacineDRUG
PrednisoneDRUG
VincristineDRUG
BleomycinDRUG
Erythropoietin betaDRUG

Eligibility Criteria

Age61 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hodgkin´s lymphoma (histologically proven)
  • CS (PS) I and II with one of the risk factors a-d
  • bulky mediastinal mass (\> 1/3 maximum transverse thorax diameter)
  • extranodal involvement
  • ESR \> 50 (A), \> 30 (B-symptoms)
  • or more lymph node areas involved
  • CS (PS) III and IV
  • Written informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cologne

Cologne, 50931, Germany

Location

Related Publications (1)

  • 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.

    PMID: 20551376RESULT

MeSH Terms

Interventions

CyclophosphamidePrednisoneVincristineBleomycin

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesGlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Andreas Josting, Dr.

    University of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 27, 2006

First Posted

January 31, 2006

Study Start

January 1, 2004

Primary Completion

December 1, 2005

Last Updated

July 29, 2011

Record last verified: 2011-07

Locations

DE(1)