Status:
UNKNOWN
Risk Adapted Therapy Optimization for Patients With Relapsed or Refractory Aggressive Non-Hodgkin-Lymphoma
Lead Sponsor:
University of Magdeburg
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This study investigates toxicity and efficacy of 2 x R-DHAP followed by High dose chemotherapy R-TEC and autologous stem cell transplantation in patients with relapsed or refractory aggressive Non- Ho...
Detailed Description
Initial Cytoreduction is performed with DHAP- protocol using dexamethasone, cytarabine and cisplatin followed by high dose chemotherapy with treosulfan, etoposide and cisplatin (TEC) an autologous per...
Eligibility Criteria
Inclusion
- first relapse or primary refractory disease of aggressive Non-Hodgkin's lymphoma stage I-IV
- pretreatment with systemic therapy
- 18-65 years of age
- Performance status:ECOG 0-2
- Granulocyte count \>1.5/µm3, Platelet count \>100/µm3
- Creatinine -Clearance ≥ 1 ml/sec
- GPT/GOT ≤ 1.5 x normal (except tumour related)
- Bilirubine \< 22 µmol/l
- no participation in another study 3 month before and during this study
- informed consent
Exclusion
- Second neoplasia in history or existing except basalioma or squamous epithelium carcinoma of the skin or removed cervical intraepithelial neoplasia
- CNS- involvement by lymphoma
- respiratory Partial- or global insufficiency
- cardiac insufficiency (NYHA-Stage 3-4, EF \< 30 %)
- severe neurological or psychiatric disease
- pregnancy
- HIV positivity ,active virus hepatitis, bacterial infection
- No follow up procedures ensured
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00384553
Start Date
June 1 2004
End Date
June 1 2010
Last Update
October 6 2006
Active Locations (1)
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1
University of Magdeburg
Magdeburg, Germany, 39120