Risk Adapted Therapy Optimization for Patients With Relapsed or Refractory Aggressive Non-Hodgkin-Lymphoma

• Status: Unknown status
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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- Hodgkins's Lymphoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Magdeburg
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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