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Protocol for a Randomised Phase II Study of the Stanford V regimen compared with ABVD for the treatment of Advanced Hodgkin's Disease

Protocol for a Randomised Phase II Study of the Stanford V regimen compared with ABVD for the treatment of Advanced Hodgkin's Disease

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN64141244
Enrollment
700
Registered
2002-08-19
Start date
2001-01-01
Completion date
Unknown
Last updated
2018-11-12

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

Conditions

Lymphoma (Hodgkin's) Cancer Hodgkin's disease

Interventions

STANFORD V regimen: Chemotherapy with mustine, doxorubicin, vinblastine, prednisolone, vincristine, bleomycin and etoposide ABVD Regimen: Chemotherapy with doxorubicin, bleomycin, vinblastine and da

Sponsors

British National Lymphoma Investigation (BNLI) (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed Hodgkin's disease 2. Clinical stage IIB, IIIA, IIIB or IV 3. Aged 18 - 60 years 4. No previous history of malignancy, except for basal cell or squamous cell carcinoma of the skin 5. Normal values for Full Blood Count (FBC), hepatic and renal function, unless directly attributable to involvement by Hodgkin's disease 6. Written informed consent 7. All patients must be assessed by the treating haematologist/medical oncologist and radiation oncologist TOGETHER prior to study entry. This is an absolute requirement for the study eligibility

Exclusion criteria

Exclusion criteria: 1. Previous therapy for Hodgkin?s disease 2. Clinical evidence of infection with the Human Immunodeficiency Virus (HIV) 3. Pre-existing cardiac or pulmonary disease

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026