HD 16 for early stages, treatment optimization trial in the first-line treatment of early stage Hodkgin lymphoma; treatment stratification by means of FDG-PET.
- Conditions
- malignant lymphomaHodgkin's disease10025319
- Registration Number
- NL-OMON47064
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 19
1.Histologically proven primary diagnosis of Hodgkin lymphoma;
2. Stage: I and II without risk factor
3. Patient had no previous treatment for HL;
4. Age at entry: 18 - 75 years;
5. 6. Normal organ function (except HL-related);
6. Negative HIV test
7. In women: negative pregnancy test
8. Life expectancy > 3 months
1. Incomplete diagnosis of the disease stage;
2. Prior or concurrent disease that prevents treatment according to protocol;
3. HL as composite lymphoma;
4. Prior chemotherapy or radiation;
5. Malignant disease within the last 5 years (exceptions: basalioma, carcinoma in
situ of the cervix uteri, completely resected melanoma TNMpT1);
6. Pregnancy, lactation;
7. WHO activity index > 2;
8. Long-term administration of corticosteroids (e.g. for chronic polyarthritis) or
antineoplastic drugs (e.g. methotrexate)
9. Non-compliance
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Progression Free Survival (PFS)</p><br>
- Secondary Outcome Measures
Name Time Method <p>CR rate<br /><br>Overall survival<br /><br>late toxicity of treatment<br /><br>Secondary maligancy rate<br /><br>Rate of patients who are PET positive and PET negative after to 2 cycles of<br /><br>ABVD</p><br>