A randomised trial of BEAM plus peripheral blood stem cell transplantion (PBSCT) versus single agent high-dose therapy followed by BEAM plus PBSCT in patients with relapsed Hodgkin's disease

Phase 3

Completed

• Conditions: Hodgkin's disease; Cancer

• Registration Number: ISRCTN72542803
• Lead Sponsor: German Hodgkin's Lymphoma Study Group (Germany)

Brief Summary

1. Protocol in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=12223998 2. 2010 results in https://www.ncbi.nlm.nih.gov/pubmed/20975066 (added 28/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-10-29
• Study Completion: 2006-07-01
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. Histologically confirmed early or late first relapsed Hodgkin's disease or second relapsed Hodgkin's disease without prior high-dose chemotherapy
2. Age: 18 - 60 years
3. Eastern Cooperative Oncology Group (ECOG) less than or equal to 2, Karnofsky performance status equalling 70
4. Life expectancy greater than 3 months with treatment
5. Absolute Neutrophil Count (ANC) greater than 2.5 x 10^9/l and platelets greater than 100 x 10^9/l
6. Written informed consent

Exclusion Criteria

1. Active infection
2. Concurrent other malignancy other than adequately treated basal-cell carcinoma of the skin or cervical intra-epithelial neoplasia
3. Significant non-malignant disease:
3.1. Human Immunodeficiency Virus (HIV)-infection
3.2. Uncontrolled hypertension
3.3. Unstable angina
3.4. Heart failure (New York Heart Association [NYHA] II)
3.5. Chronic Obstructive Pulmonary Disease (COPD)
3.6. Poorly controlled diabetes mellitus
3.7. Cerebral disorder
3.8. Coronary angioplasty or myocardial infarction within the last 6 months
3.9. Uncontrolled atrial or ventricular cardiac arrythmias
4. Creatinine clearance less than 60 ml/min
5. Pregnancy or lactating women, non adequate contraception
6. Patients currently receiving investigational drugs
7. Inability to give truly informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified