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

High dose therapy of relapsed or refractory aggressive non-Hodgkin lymphoma: a phase II study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN09311427

Enrollment

100

Registered

2012-03-30

Start date

2004-08-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory or relapsed non-Hodgkin lymphoma Cancer Non-Hodgkin lymphoma, unspecified

Interventions

Two cycles of rituximab, dexamethasone, cytarabine, cisplatin (R-DHAP) regimen immunochemotherapy are performed including rituxan (anti-CD20 monoclonal antibody), dexamethasone, high dose cytarabin an

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Toxicity of the regimen 2. Overall survival 3. Disease free survival	—

Secondary

Measure	Time frame
1. Development of graft-versus-host-disease (GVHD) 2. Minimal residual disease (MRD)	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026