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

Phase 2

Completed

• Conditions: Hodgkin's lymphoma; Cancer

• Registration Number: ISRCTN87375595
• Lead Sponsor: ewcastle Hospitals NHS Trust (UK)

Brief Summary

2012 results in https://www.ncbi.nlm.nih.gov/pubmed/22577177

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-08-18
• Study Completion: 2009-08-31
• Last Update Posted: 18 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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.<br><br> 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.<br>

Secondary Outcome Measures

Name	Time	Method
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.