PVAG-14 Pilot for Intermediate Stages Hodgkin Lymphoma
- Conditions
- Hodgkin Lymphoma
- Interventions
- Registration Number
- NCT00512980
- Lead Sponsor
- University of Cologne
- Brief Summary
A randomized phase II study of prednisone, vinblastine, doxorubicin, and gemcitabine in patients with intermediate stage Hodgkin's lymphoma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
-
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)
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Age: 18-60 years
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Signed informed consent with understanding of the study procedures and the investigational nature of the study
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Patient agrees that personal data and tissue samples are provided to the GHSG (protection of privacy as defined by law will be ensured)
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Life expectancy > 3 months according to investigator judgement.
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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)
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Pregnancy, lactation, positive pregnancy test
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Refusal to use effective contraception
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WHO performance index > 2
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Long-term ingestion of corticosteroids (e.g. for chronic polyarthritis) or antineoplastic drugs (e.g. methotrexate)
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Patient's lack of accountability, inability to appreciate the nature, meaning and consequences of the trial and to formulate his/her own wishes correspondingly
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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
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Antiepileptic treatment
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General intolerance of any protocol medication
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 prednisone - 1 vinblastine - 1 doxorubicin - 2 prednisone - 2 vinblastine - 2 doxorubicin - 1 gemcitabine - 2 gemcitabine -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Cologne
🇩🇪Cologne, Germany