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
| ISRCTN | ISRCTN72542803 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72542803 |
| ClinicalTrials.gov number | NCT00025636 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/09/2003
- Registration date
- 29/10/2003
- Last edited
- 28/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Andreas Engert
Scientific
Scientific
Department I of Internal Medicine
University of Cologne
Joseph-Stelzmann-Str. 9
Cologne
50924
Germany
| Phone | +49 (0)221 478-5933 (3557/3558) |
|---|---|
| dhsg@biometrie.uni-koeln.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information material can be seen at http://www.lymphome.de/Gruppen/GHSG/Protokolle/HD-R2/PatientInformation.pdf |
| Scientific title | 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 |
| Study acronym | HD-R2 |
| Study objectives | To compare efficacy and toxicity of a sequential HDCT and a standard HDCT in patients with histologically confirmed relapsed Hodgkins disease. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Hodgkin's disease |
| Intervention | All patients will receive 2 cycles of Dexamethasone, Cytarabine, Cisplatin (DHAP) and Granulocyte Colony-Stimulating Factor (G-CSF). After the first (and/or second) course of DHAP, PBSC will be collected by apheresis. Response evaluation will then be performed and patients with CR/PR/stable disease will proceed as intended via randomisation: Arm A: Carmustin, etoposide, cytarabine, melphalan (BEAM) and G-CSF followed by PBSCT Arm B: High-dose cyclophosphamide, followed by high-dose methotrexate and vincristine, followed by high-dose etoposide, and BEAM and G-CSF followed by PBSCT |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Carmustin, etoposide, cytarabine, melphalan (BEAM), cyclophosphamide (CTX), methotrexate (MTX), vincristin, etoposide |
| Primary outcome measure | Freedom From Treatment Failure (FFTF) |
| Secondary outcome measures | 1. Complete Remission (CR), Complete Remission unconfirmed (CRu) rates 3 months after end of protocol 2. Relapse-Free Survival (RFS) 3. Overall Survival (OS) 4. Frequency of severe toxicities (World Health Organization [WHO] grade 3 or 4) 5. Secondary neoplasia |
| Overall study start date | 01/07/2001 |
| Completion date | 01/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 220 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2001 |
| Date of final enrolment | 01/07/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Department I of Internal Medicine
Cologne
50924
Germany
50924
Germany
Sponsor information
German Hodgkin's Lymphoma Study Group (Germany)
Research organisation
Research organisation
Herderstr. 52-54
Cologne
50924
Germany
| Phone | +49 (0)221 478-3557 (-3558) |
|---|---|
| dhsg@biometrie.uni-koeln.de | |
| Website | http://www.lymphome.de/en/Groups/GHSG/ |
Funders
Funder type
Research organisation
European Group for Blood and Bone Marrow Transplantation (EORTC) Lymphoma Group
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 01/08/2002 | Yes | No | |
| Results article | results | 01/12/2010 | 28/01/2019 | Yes | No |
Editorial Notes
28/01/2019: Publication reference added
