High dose therapy of relapsed or refractory aggressive non-Hodgkin lymphoma

ISRCTN	ISRCTN09311427
DOI	https://doi.org/10.1186/ISRCTN09311427
Secondary identifying numbers	OSHO #71

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Study website

Contact information

Prof Michael Koenigsmann
Scientific

Marienstr. 90
Hannover
30171
Germany

Email	koenigsmann@onkologie-hannover.de

Study information

Study design	Non-randomized phase II trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Rituximab, dexamethasone, cytarabine, cisplatin (R-DHAP)
Primary outcome measure	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 study start date	01/08/2004
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	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

Marienstr. 90

Hannover
30171
Germany

Sponsor information

Eastern German Study Group for Haematology and Oncology (OSHO) (Germany)
Research organisation

Ostdeutsche Studiengruppe für Hämatologie und Onkologie e.V.
Universitätsklinikum Leipzig AÖR
Johannisallee 32A
Leipzig
04103
Germany

Email	Rainer.Krahl@medizin.uni-leipzig.de
"ROR"	https://ror.org/028hv5492

Funders

Funder type

Government

German Health Insurance System (Germany)

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

Editorial Notes

09/09/2016: Plain English summary added.