Condition category
Cancer
Date applied
22/03/2012
Date assigned
30/03/2012
Last edited
09/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.lymphome.de/Gruppen/OSHO/Protokolle/71/index.jsp

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

Publication citations

Additional files

Editorial Notes

09/09/2016: Plain English summary added.