A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years; Vinblastine, Cyclophosphamide, Procarbazine, Prednisolone, Etoposide, Mitoxantrone, and Bleomycin in Treating Older Patients With Hodgkin's Lymphoma
bleomycin sulfate
+ cyclophosphamide
+ etoposide
Hodgkin Disease+5
+ Immune System Diseases
+ Immunoproliferative Disorders
Treatment Study
Summary
Study start date: January 1, 2004
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Determine the efficacy and toxicity of vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin in older patients with Hodgkin's lymphoma. * Determine whether the application of the Hasenclever prognostic index is valid in these patients at diagnosis. OUTLINE: This is an open-label, multicenter study. * Chemotherapy: Patients receive vinblastine IV and cyclophosphamide IV on day 1; oral procarbazine and oral prednisolone on days 1-5; oral etoposide on days 15-19; and mitoxantrone IV and bleomycin IV on day 15. Treatment repeats every 28 days, in the absence of disease progression or unacceptable toxicity, for a total of 3 courses in patients with early (stage IA or IIA) disease or 6 courses in patients with advanced (stage IB or IIB-IV) disease. * Radiotherapy: Patients with early stage disease receive involved-field radiotherapy. Patients with advanced stage disease receive radiotherapy limited to sites of initial bulky disease or residual disease. Radiotherapy begins 4 weeks after the completion of chemotherapy. Patients are followed monthly for 3 months, every 3 months for 6 months, and then annually thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 36 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.175 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 60 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion criteria: Histologically confirmed classical Hodgkin Lymphoma (HL). No previous treatment for HL. Age ≥ 60. "Non fragile" patient (see Appendix 1) i.e. patient's mental and physical status must be sufficient to withstand the treatment described. No concomitant neoplasia requiring treatment or known HIV infection. Written informed consent. Exclusion criteria: Nodular lymphocyte predominance Hodgkin Lymphoma (NLPHL) Age \<60. Patient previously treated for HL. Known HIV infection or concomitant neoplasia. "Fragile patient" (see Appendix 1) or significant abnormality of another system (pulmonary, cardiac, renal, and hepatic) which is a contraindication to full dose chemotherapy. Unable to give informed consent.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 54 locations
Wansbeck General Hospital
Ashington, United KingdomBasingstoke and North Hampshire NHS Foundation Trust
Basingstoke, United KingdomRoyal United Hospital
Bath, United Kingdom