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

Phase 2

Completed

• Conditions: Refractory or relapsed non-Hodgkin lymphoma; Cancer; Non-Hodgkin lymphoma, unspecified

• Registration Number: ISRCTN09311427
• Lead Sponsor: Eastern German Study Group for Haematology and Oncology (OSHO) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-30
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Toxicity of the regimen<br>2. Overall survival<br>3. Disease free survival

Secondary Outcome Measures

Name	Time	Method
1. Development of graft-versus-host-disease (GVHD)<br>2. Minimal residual disease (MRD)