Plain English Summary
Background and study aims
Non-Hodgkin lymphoma is an uncommon cancer that develops in the lymphatic system, which is a network of vessels and glands spread throughout the body. Patients whose disease does not respond to treatment (refractory) or whose disease returns (relapsed) have a dismal outcome. New treatments therefore need to be explored. High doses of chemotherapy drugs and radiotherapy are used to kill off the cancer cells but they also damage the bone marrow, including the stem cells. This means the body can't make any new blood cells. Before chemotherapy the patient’s stem cells are therefore frozen and stored, and after chemotherapy they are given back through a drip (autologous stem cell transplantation). It is also possible to have stem cells donated by the patient’s brother or sister (allogeneic stem cell transplantation). The aim of this study is to find out whether allogeneic stem cell transplantation is superior to autologous stem cell transplantation for patients with relapsed or refractory non-Hodgkin lymphoma.
Who can participate?
Patients age 18 - 65 with refractory or relapsed non-Hodgkin-lymphoma
What does the study involve?
Participants receive two cycles of immunochemotherapy (combined immunotherapy and chemotherapy). Patients who achieve a partial or complete remission (disappearance of signs and symptoms) after autologous transplantation receive a second autologous stem cell transplantation. Patients whose disease is either refractory or at early relapse receive allogeneic transplantation.
What are the possible benefits and risks of participating?
A possible benefit from this study is a higher probability to survive the disease. Potential risks include infectious complications and development of graft-versus-host disease (where the donated cells attack the body).
Where is the study run from?
Eastern German Study Group for Hematology and Oncology (OSHO)
When is the study starting and how long is it expected to run for?
August 2004 to December 2012
Who is funding the study?
Costs are covered by the participating centers with refunding from the German health insurance system
Who is the main contact?
Prof. Dr. Michael Koenigsmann
koenigsmann@onkologie-hannover.de
Trial website
Contact information
Type
Scientific
Primary contact
Prof Michael Koenigsmann
ORCID ID
Contact details
Marienstr. 90
Hannover
30171
Germany
-
koenigsmann@onkologie-hannover.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
OSHO #71
Study information
Scientific title
High dose therapy of relapsed or refractory aggressive non-Hodgkin lymphoma: a phase II study
Acronym
Study hypothesis
Allogeneic stem cell transplantation is superior to autologous stem cell transplantation in this setting.
Ethics approval
Ethics Committee of the University of Magdeburg, Magdeburg, Germany, 22/04/2004, ref: 46/04
Study design
Non-randomized phase II trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Refractory or relapsed non-Hodgkin lymphoma
Intervention
Two cycles of rituximab, dexamethasone, cytarabine, cisplatin (R-DHAP) regimen immunochemotherapy are performed including rituxan (anti-CD20 monoclonal antibody), dexamethasone, high dose cytarabin and cisplatin.
Treatment arm 1: Patients who received a partial or complete remission after autologous transplantation were subjected to a second autologous stem cell transplantation
Tretament arm 2: Patients in whom non-Hodgkin lymphoma (NHL) is either refractory or at early relapse, i.e. occurs within 12 months from first CR. They will receive an allo-graft if an allo-graft is available.
Intervention type
Drug
Phase
Phase II
Drug names
Rituximab, dexamethasone, cytarabine, cisplatin (R-DHAP)
Primary outcome measures
1. Toxicity of the regimen
2. Overall survival
3. Disease free survival
Secondary outcome measures
1. Development of graft-versus-host-disease (GVHD)
2. Minimal residual disease (MRD)
Overall trial start date
01/08/2004
Overall trial end date
31/12/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Refractory or relapsed aggressive Non-Hodgkin lymphoma
2. Age 18 - 65 years
3. Performance-Status (Karnofsky more than 60 %)
4. Absolute neutrophil count (ANC) >1.5/µl
5. Platelets (PLT) >100/µl
6. Creatinin clearance > 1 ml/sec
7. Liver function test > 1.5 fold of upper normal level (UNL)
8. Bilirubin < 22 µmol/l
9. Informed consent
10. No participation in another trial
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Second malignoma in the history other than basalioma
2. Central nervous system (CNS) lymphoma
3. Respiratory failure
4. Heart failure [New York Heart Association (NYHA) stage 3-4, ejection fraction < 30 %]
5. Severe neurological / psychiatric disease
6. Pregnancy, ineffective contraception
7. Preceding kidney transplantation
8. Positive Human immunodeficiency virus (HIV) test
9. Active viral hepatitis
10. Bacterial infection
Recruitment start date
01/08/2004
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Germany
Trial participating centre
Marienstr. 90
Hannover
30171
Germany
Sponsor information
Organisation
Eastern German Study Group for Haematology and Oncology (OSHO) (Germany)
Sponsor details
Ostdeutsche Studiengruppe für Hämatologie und Onkologie e.V.
Universitätsklinikum Leipzig AÖR
Johannisallee 32A
Leipzig
04103
Germany
-
Rainer.Krahl@medizin.uni-leipzig.de
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
German Health Insurance System (Germany)
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