High dose therapy of relapsed or refractory aggressive non-Hodgkin lymphoma
| ISRCTN | ISRCTN09311427 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09311427 |
| Protocol serial number | OSHO #71 |
| Sponsor | Eastern German Study Group for Haematology and Oncology (OSHO) (Germany) |
| Funder | German Health Insurance System (Germany) |
- Submission date
- 22/03/2012
- Registration date
- 30/03/2012
- Last edited
- 09/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
Marienstr. 90
Hannover
30171
Germany
| koenigsmann@onkologie-hannover.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomized phase II trial |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | High dose therapy of relapsed or refractory aggressive non-Hodgkin lymphoma: a phase II study |
| Study objectives | Allogeneic stem cell transplantation is superior to autologous stem cell transplantation in this setting. |
| Ethics approval(s) | Ethics Committee of the University of Magdeburg, Magdeburg, Germany, 22/04/2004, ref: 46/04 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Rituximab, dexamethasone, cytarabine, cisplatin (R-DHAP) |
| Primary outcome measure(s) |
1. Toxicity of the regimen |
| Key secondary outcome measure(s) |
1. Development of graft-versus-host-disease (GVHD) |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2004 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Germany
Study participating centre
30171
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/09/2016: Plain English summary added.
