PVAG-14 Pilot for Intermediate Stages Hodgkin Lymphoma

Sponsor

University of Cologne (Other)

Overall Status

Terminated

CT.gov ID

NCT00512980

Collaborator

(none)

Location

Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hodgkin Lymphoma	Drug: prednisone Drug: vinblastine Drug: doxorubicin Drug: gemcitabine	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

A Randomized Phase II Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Patients With Intermediate Stage Hodgkin's Lymphoma

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1	Drug: prednisone Drug: vinblastine Drug: doxorubicin Drug: gemcitabine
Active Comparator: 2	Drug: prednisone Drug: vinblastine Drug: doxorubicin Drug: gemcitabine

Arm

Intervention/Treatment

Active Comparator: 1

Drug: prednisone

Drug: vinblastine

Drug: doxorubicin

Drug: gemcitabine

Active Comparator: 2

Drug: prednisone

Drug: vinblastine

Drug: doxorubicin

Drug: gemcitabine

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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)
Pregnancy, lactation, positive pregnancy test
Refusal to use effective contraception
WHO performance index > 2
Long-term ingestion of corticosteroids (e.g. for chronic polyarthritis) or antineoplastic drugs (e.g. methotrexate)
Patient's lack of accountability, inability to appreciate the nature, meaning and consequences of the trial and to formulate his/her own wishes correspondingly
Non compliance: Refusal of blood products during treatment, epilepsy, drug dependency, change of residence abroad, prior cerebral injury or similar circumstances which appear to make protocol treatment or long-term follow-up impossible
Antiepileptic treatment
General intolerance of any protocol medication
Any contraindication for study medication according to the summaries of product information
Simultaneous participation in another clinical
Institutionalization by law
Relation of dependence with the sponsor's representative / trialist