PVAG-14 Pilot for Intermediate Stages Hodgkin Lymphoma

NCT00512980 | Terminated Phase 2

• 1 other identifier: PVAG-14 pilot
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized phase II study of prednisone, vinblastine, doxorubicin, and gemcitabine in patients with intermediate stage Hodgkin's lymphoma

Conditions

Hodgkin Lymphoma

Keywords

intermediate stages

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: prednisone; Drug: vinblastine; Drug: doxorubicin; Drug: gemcitabine

2

ACTIVE COMPARATOR

Drug: prednisone; Drug: vinblastine; Drug: doxorubicin; Drug: gemcitabine

Interventions

prednisone DRUG

1; 2

vinblastine DRUG

1; 2

doxorubicin DRUG

1; 2

gemcitabine DRUG

1; 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Histologically confirmed diagnosis of Hodgkin's lymphoma
• Stage
• Clinical Stage IA, IB, IIA with at least one of the risk factors a-d given below
• Clinical Stage IIB with one or both risk factors c-d given below risk factors:
• Large mediastinal mass (≥ 1/3 of the greatest thorax diameter as measured by chest x-ray)
• Extranodal involvement
• High erythrocyte sedimentation rate (≥ 50 mm/h in patients without B-symptoms, ≥ 30 mm/h in patients with B-symptoms)
• Three or more involved lymph node areas
• No prior therapy for Hodgkin's lymphoma (exception: pre-phase treatment with corticosteroids and vinca-alkaloids for a maximum of seven days may not preclude trial participation if clinically indicated and all staging examinations have been performed; all forms of prior radiotherapy preclude trial participation)
• Age: 18-60 years
• Signed informed consent with understanding of the study procedures and the investigational nature of the study
• Patient agrees that personal data and tissue samples are provided to the GHSG (protection of privacy as defined by law will be ensured)
• Life expectancy \> 3 months according to investigator judgement.

You may not qualify if:

• Incomplete diagnosis of stage of disease
• Prior or concurrent disease which prevents treatment according to protocol In particular the following contraindications:
• Chronic obstructive pulmonary disease with global insufficiency
• Symptomatic coronary heart disease
• Cardiomyopathy or cardiac insufficiency (NYHA value of EF \< 50% or FS \< 25%)
• Serious uncontrolled hypertension
• Uncontrollable infection
• Leucocyte concentration \< 3.000/mm3 or thrombocyte concentration \< 100.000/mm3
• Creatinin clearance \< 60 ml/min
• Bilirubin \> 2 mg/dl or GPT \> 100 U/l or GOT \> 100 U/I (exception: elevated values of Hodgkin's disease liver involvement)
• HIV-Infection according to HIV test
• Chronic or acute Hepatitis
• HD as composite lymphoma
• Prior chemotherapy or radiation
• Malignant disease within the last 5 years (exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1)

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University of Cologne

Cologne, Germany

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Prednisone; Vinblastine; Doxorubicin; Gemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Aminoglycosides; Glycosides; Carbohydrates; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Andreas Engert, Prof

  University of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 7, 2007
• First Posted: August 8, 2007
• Study Start: August 1, 2008
• Primary Completion: November 1, 2013
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

DE (1)