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A phase II study of vinblastine, endoxana (cyclophosphamide), procarbazine, prednisolone, etoposide, mitoxantrone and bleomycin in patients with Hodgkin's lymphoma aged over 60 years

A phase II study of vinblastine, endoxana (cyclophosphamide), procarbazine, prednisolone, etoposide, mitoxantrone and bleomycin in patients with Hodgkin's lymphoma aged over 60 years

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN87375595
Enrollment
150
Registered
2006-08-18
Start date
2004-09-01
Completion date
Unknown
Last updated
2019-03-18

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

Conditions

Hodgkin's lymphoma Cancer Hodgkin's lymphoma

Interventions

The patient either receives the VEPEMB treatment or is simply registered on the database and the alternative treatment which they receive is recorded. The patient's treatment is determined by their ph

Sponsors

Newcastle Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed classical Hodgkin's Lymphoma (HL) 2. No previous treatment for HL 3. Aged over 60 4. "Non fragile" patients, i.e. patient?s mental and physical status must be sufficient to withstand the treatment described 5. No concomitant neoplasia or known Human Immunodeficiency Virus (HIV) infection 6. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Nodular Lymphocyte Predominance Hodgkin's Lymphoma (NLPHL) 2. Aged under 60 3. Patient previously treated for HL 4. Known HIV infection or concomitant neoplasia 5. "Fragile patient" or significant abnormality of another system (pulmonary, cardiac, renal, and hepatic) which is a contraindication to full dose chemotherapy 6. Unable to give informed consent

Design outcomes

Primary

MeasureTime frame
The primary endpoints will be progression-free survival, with clinical progression and death as the events. On suspicion of progression (e.g. new or enlarging masses, development of ?B? symptoms) patients should be re-evaluated according to normal procedures to confirm relapse. Histological confirmation of relapse is recommended but not mandatory. Survival time, including death from any cause, will also be investigated. For both endpoints, the event-free times will be dated from the date of histological diagnosis.

Secondary

MeasureTime frame
Analysis will be done to assess potential prognostic factors (Epstein-Barr Virus [EBV] status, "Fragility" assessment, Hasenclever index, soluble form of the CD30 molecule [sCD30]) which might be relevant in this age group.

Countries

United Kingdom

Outcome results

None listed

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