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Phase ll study evaluating the toxicity and efficacy of a modified German Paediatric Hodgkin's Lymphoma protocol (HD95) in young adults (aged 18-30 years) with Hodgkin's Lymphoma - 18-30 Study

Phase 1
Conditions
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)
Registration Number
EUCTR2007-003080-45-GB
Lead Sponsor
niversity College London
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Not specified
Target Recruitment
0
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

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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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