Medical condition under investigation is known as Hodgkin's disease, which is a cancer of the lymphatic system. It is usually treated with either chemotherapy or radiotherapy or a combination of both. MedDRA version: 14.0 Level: LLT Classification code 10020328 Term: Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Doxorubicin hydrochloride
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: DOXORUBICIN HYDROCHLORIDE
CAS Number
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Biopsy proven de novo calssical Hodgkin's lymphoma 2) No previous chemotherapy or radiotherapy 3) Age 18-30 years 4) Any stage 5) Able to give informed consent 6) Agreement to take adequate precautions to prevent conception during chemo-/radiotherapy and for up to one year afterwards Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Nodular Lymphocyte Predominant Hodgkin's disease 2) Previous chemotherapy or radiotherapy 3) Known or suspected HIV infection 4) Pre-existing neurological disorder 5) Serious co-morbidity which may prevent administration of study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective of this study is to determine whether young adults (18-30 years) can receive modified HD95 therapy without experiencing excessive neurotoxicity due to the intensive use of Vinca alkaloids in this regimen.; Secondary Objective: Secondary outcomes: 1) the response rates, disease free survival and overall survival 2) gonadal toxicity ; Primary end point(s): The purpose of this study is to determine if the excellent results seen in patients under the age of 18 treated on the HD95 protocol can be reproduced in older patients. Achieving disease control whilst reducing the long term side effects of therapy is central to modern therapy of Hodgkin's Lymphoma. Improving the event free survival of patients with Hodgkin's disease will reduce the need for salvage chemotherapy and stem cell transplantation and the inherent long-term side effects of such therapy. The event free survival of children and adolescents (50 ml will be limited to 30Gy not 35 Gy | — |
Countries
United Kingdom
Outcome results
None listed