HD21 for advanced stages: Treatment optimization trial in the first-line treatment of advanced stage Hodgkin lymphoma; comparison of 4-6 cycles of escalated BEACOPP with 4-6 cycles of BrECADD; a randomized phase III trial

Phase 3

Recruiting

Conditions: Hodgkin's disease
malignant lymphoma
10025319

Registration Number: NL-OMON50640

Lead Sponsor: niversitly of Cologne

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

- Histologically proven classical Hodgkin lymphoma
- First diagnosis, no previous treatment
- 18 to 60 years of age; cohort elderly: 61-75 years
- Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or
IV

Exclusion Criteria

- Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma
-Previous malignancy (exceptions: basalioma, carcinoma in situ of the cervix
uteri, completely resected melanoma TNMpT1)
- Prior chemotherapy or radiotherapy
- Concurrent disease which precludes protocol treatment
- Pregnancy, lactation
- Non-Compliance

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Progression Free Survival (PFS).<br /><br>- the rate of serious treatment- related toxicities during primary treatment.<br /><br><br /><br><br /><br>New cohort for elderly 61-75 years:<br /><br>- Complete response (CR) rate after chemotherapy</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- CR rate<br /><br>- Overall survival<br /><br>- Infertility rate at 1 year (determined by hormone levels)<br /><br>- second malignancies<br /><br>- number of serious adverse events within 30 days after end of treatment.<br /><br>- therapy adherence<br /><br>- quality of life before, during and after therapy<br /><br><br /><br><br /><br>Cohort elderly patients 61-75 years:<br /><br>- Treatment related morbidity<br /><br>- PFS and OS<br /><br>- time to progression and HL-specific survival</p><br>