NCT00147875

Brief Summary

The objectives of this study are to assess the feasibility and efficacy of a combination chemotherapy (PVAG) in elderly patients with advanced stages Hodgkin's lymphoma.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

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

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Last Updated

September 7, 2009

Status Verified

September 1, 2009

Enrollment Period

3.3 years

First QC Date

September 2, 2005

Last Update Submit

September 4, 2009

Conditions

Hodgkin's Disease

Keywords

LymphomaGemcitabineAdvanced stages Hodgkin's lymphomaElderly

Outcome Measures

Primary Outcomes (2)

  • Phase I: Dose-limiting toxicities and dose reductions

  • Phase II: Treatment administration and complete response rate

Secondary Outcomes (4)

  • Toxicities

  • Supportive care (RBCT need, antibiotic need)

  • Early progression rate

  • Overall survival

Interventions

PrednisoneDRUG
VinblastineDRUG
Doxorubicin (Adriamycin)DRUG
GemcitabineDRUG

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hodgkin's lymphoma (histologically proven)
  • Clinical stage IIB (with risk factors bulky mediastinal mass and/or extranodal involvement), III, or IV
  • No prior antitumor therapy
  • Age 60 to 75 years
  • WHO performance status 0-2
  • Normal pulmonary function
  • Written informed consent

You may not qualify if:

  • The following histologies are excluded: lymphocyte predominant HD
  • Leukocytes \< 2,500/microL
  • Platelets \< 100,000/microL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cologne

Cologne, North Rhine-Westphalia, 50924, Germany

Location

Related Publications (1)

  • Boll B, Bredenfeld H, Gorgen H, Halbsguth T, Eich HT, Soekler M, Markova J, Keller U, Graeven U, Kremers S, Geissler M, Trenn G, Fuchs M, von Tresckow B, Eichenauer DA, Borchmann P, Engert A. Phase 2 study of PVAG (prednisone, vinblastine, doxorubicin, gemcitabine) in elderly patients with early unfavorable or advanced stage Hodgkin lymphoma. Blood. 2011 Dec 8;118(24):6292-8. doi: 10.1182/blood-2011-07-368167. Epub 2011 Sep 13.

    PMID: 21917759DERIVED

MeSH Terms

Conditions

Hodgkin DiseaseLymphoma

Interventions

PrednisoneVinblastineDoxorubicinGemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAminoglycosidesGlycosidesCarbohydratesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Andreas Engert

    University of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

March 1, 2004

Primary Completion

July 1, 2007

Last Updated

September 7, 2009

Record last verified: 2009-09

Locations

DE(1)