A randomized phase II study of prednisone, vinblastine, doxorubicin, and gemcitabine in patients with intermediate stage Hodgkin's lymphoma - PVAG-14 pilot
- Conditions
- Hodgkin`s lymphoma, intermediate stage
- Registration Number
- EUCTR2007-003467-48-DE
- Lead Sponsor
- niversität zu Köln
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
1. Histologically confirmed diagnosis of Hodgkin's lymphoma
2. Clinical Stage IA, IB, IIA with at least one of the riskfactors a-d given below, or Clinical Stage IIB with one or both riskfactors c-d given below
Riskfactors:a) Large mediastinal mass (= 1/3 of the greatest thorax diameter as measured by chest x-ray), b) Extranodal involvement, c) High erythrocyte sedimentation rate (= 50 mm/h in patients without B-symptoms, = 30 mm/h in patients with B-symptoms), d)Three or more involved lymph node areas
3. No prior therapy for Hodgkin's lymphoma
4. Age: 18-60 years
5. Signed informed consent with understanding of the study procedures and the investigational nature of the study.
6. Patient agrees that personal data and tissue samples are provided to the GHSG (protection of privacy as defined by law will be ensured)
7. Life expectancy > 3 months according to investigator judgement.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Incomplete diagnosis of stage of disease
2. Prior or concurrent disease which prevents treatment according to protocol
3. HD as composite lymphoma
4. Prior chemotherapy or radiation
5. Malignant disease within the last 5 years
6. Pregnancy, lactation
7. WHO performance index > 2
8. Long-term ingestion of corticosteroids (e.g. for chronic polyarthritis) or antineoplastic drugs (e.g. methotrexate)
9. Non compliance
10. 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
11. Antiepileptic treatment
12. General intolerance of any protocol medication
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objectives of this trial are to assess the toxicity and activity of PVAG-14 in patients with intermediate-stage Hodgkin's lymphoma.<br>;Secondary Objective: The secondary objectives are to estimate feasibility, efficacy and safety of PVAG-14 in patients with intermediate-stage Hodgkin's lymphoma.<br> <br>;Primary end point(s): -Incidence of hematological toxicity grade III/IV<br>-Complete tumor response rate
- Secondary Outcome Measures
Name Time Method