Condition category
Cancer
Date applied
11/09/2003
Date assigned
29/10/2003
Last edited
14/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andreas Engert

ORCID ID

Contact details

Department I of Internal Medicine
University of Cologne
Joseph-Stelzmann-Str. 9
Cologne
50924
Germany
+49 (0)221 478-5933 (3557/3558)
dhsg@biometrie.uni-koeln.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00025636

Protocol/serial number

N/A

Study information

Scientific title

Acronym

HD-R2

Study hypothesis

To compare efficacy and toxicity of a sequential HDCT and a standard HDCT in patients with histologically confirmed relapsed Hodgkin’s disease.

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information material can be seen at http://www.lymphome.de/Gruppen/GHSG/Protokolle/HD-R2/PatientInformation.pdf

Condition

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

Phase

Phase III

Drug names

Carmustin, etoposide, cytarabine, melphalan (BEAM), cyclophosphamide (CTX), methotrexate (MTX), vincristin, etoposide

Primary outcome measures

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 trial start date

01/07/2001

Overall trial end date

01/07/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

220

Participant 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

Recruitment start date

01/07/2001

Recruitment end date

01/07/2006

Locations

Countries of recruitment

Germany

Trial participating centre

Department I of Internal Medicine
Cologne
50924
Germany

Sponsor information

Organisation

German Hodgkin's Lymphoma Study Group (Germany)

Sponsor details

Herderstr. 52-54
Cologne
50924
Germany
+49 (0)221 478-3557 (-3558)
dhsg@biometrie.uni-koeln.de

Sponsor type

Research organisation

Website

http://www.lymphome.de/en/Groups/GHSG/

Funders

Funder type

Research organisation

Funder name

European Group for Blood and Bone Marrow Transplantation (EORTC) Lymphoma Group

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Protocol in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=12223998

Publication citations

  1. Protocol

    Glossmann JP, Josting A, Pfistner B, Paulus U, Engert A, , A randomized trial of chemotherapy with carmustine, etoposide, cytarabine, and melphalan (BEAM) plus peripheral stem cell transplantation (PBSCT) vs single-agent high-dose chemotherapy followed by BEAM plus PBSCT in patients with relapsed Hodgkin's disease (HD-R2)., Ann. Hematol., 2002, 81, 8, 424-429, doi: 10.1007/s00277-002-0495-y.

Additional files

Editorial Notes