A study to improve the treatment in the first-line treatment of advanced stage Hodgkin lymphoma

Phase 1

Conditions: Treatment optimization trial in the first-line treatment of advanced stage Hodgkin lymphoma
MedDRA version: 20.0Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's diseaseSystem Organ Class: 10005329 - Blood and lymphatic system disorders

Registration Number: EUCTR2014-005130-55-DE

Lead Sponsor: niversity of Cologne

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1500

Inclusion Criteria

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

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 1500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective of the trial is to demonstrate non-inferior efficacy of 4-6 cycles of BrECADD compared to 4-6 cycles of escalated BEACOPP;Secondary Objective: Tumor response (CR/CRr rate)<br>Overall survival (OS)<br>Infertility rate at 1 year<br>Second malignancies<br>Quality of life (QoL)<br>Frequency of adverse events <br>Therapy adherence<br>Event free survival;Primary end point(s): Randomized main study:<br>• Treatment-related morbidity (TRMB)<br>• Progression-free survival (PFS)<br>Cohort of older patients:<br>• Complete remission (CR) rate after chemotherapy<br>;Timepoint(s) of evaluation of this end point: Analysis of primary toxicity endpoint (16 months after LPI).<br>Interim analysis of efficacy endpoint (randomized cohort) approximately 36 months of median follow-up.<br>Superiority analysis for efficacy (randomized cohort) approximately 48 months of median follow-up.<br>Final analysis of efficacy endpoint within 6 months after LPLV.<br><br><br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Tumor response (CR/CRr rate)<br>Overall survival (OS)<br>Infertility rate at 1 year<br>Second malignancies<br>Quality of life (QoL)<br>Frequency of adverse events <br>Therapy adherence.<br>Event free survival (EFS).;Timepoint(s) of evaluation of this end point: Final analysis of secondary endpoints within 6 months after LPLV.<br>