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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

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 - HD 17 for intermediate stages

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47350
Enrollment
30
Registered
2012-08-16
Start date
2013-03-14
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malignant lymphoma

Interventions

For PET-negative patients after 4 courses of chemotherapy: end of treatment For PET-positive patients after 4 courses of chemotherapy: 30 Gy Involved Node Radiotherapy

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
Progression-free survival (PFS)

Secondary

MeasureTime frame
- CR rate - Overall survival (OS) - Proportion of patients with good / inadequate response to 2 cycles of escalated BEACOPP and 2 cycles of ABVD - Late toxicities of treatment - Secondary malignancies

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)