HD17 for Intermediate Stage Hodgkin Lymphoma - Treatment Optimization Trial in the First-Line Treatment of intermediate Stage Hodgkin lymhoma; Therapy stratification by means of FDG-PET

Phase 3

Completed

• Conditions: malignant lymphoma; Hodgkin's Disease; 10025319

• Registration Number: NL-OMON47350
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2021-03-24
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

* Histologically proven Hodgkin lymphoma
* Newly diagnosed, no previous treatment
* Stage I, IIA with RF a-d; stage IIB with RF c, d
(a: large mediastinal mass, b: extranodal disease, c: high ESR, d: * 3 lymph node areas)
* Age: 18-60 years
* Patient had no previous treatment for HL
* Normal organ function (except HL-related);
* Life expectancy > 3 months.

Exclusion Criteria

* Composite lymphoma
* Previous malignancy, prior chemotherapy or radiotherapy
* Concurrent diseases which preclude protocol treatment
* Pregnancy, lactation
* Non-compliance
* WHO activity index > 2
* Antiepileptic treatment
* Concurrent diseases which preclude protocol treatment
* Long-term administration of corticosteroids (e.g. for chronic polyarthritis) or antineoplastic drugs (e.g. azathioprine, methotrexate)

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 (OS)<br /><br>- Proportion of patients with good / inadequate response to 2 cycles of<br /><br>escalated BEACOPP and 2 cycles of ABVD<br /><br>- Late toxicities of treatment<br /><br>- Secondary malignancies</p><br>