HD 16 for early stages: treatment optimization trial in the first-line treatment of early stage Hodgkin lymphoma; treatment stratification by means of FDG-PET. - HD 16

Phase 1

• Conditions: Hodgkin's LymphomaEarly stage; MedDRA version: 12.1Level: LLTClassification code 10020328Term: Hodgkin's lymphoma

• Registration Number: EUCTR2007-004474-24-NL
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-02
• Study Completion: 2020-12-29
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1150

Inclusion Criteria

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
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: It is to be demonstrated that the experimental arm (2 cycles of ABVD with or without radiotherapy) is non-inferior to the standard arm (2 cycles of ABVD with 20 Gy IF radiotherapy) with regard to progression free survival (PFS).;Secondary Objective: CR rate<br>Overall survival<br>late toxicity of treatment<br>Secondary maligancy rate<br>Rate of patients who are PET positive and PET negative after to 2 cycles of ABVD;Primary end point(s): Progression Free Survival (PFS).