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

Phase 1

• Conditions: Non-Hodgkin's Lymphoma

• Registration Number: NCT00384553
• Lead Sponsor: University of Magdeburg

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- Hodgkins's Lymphoma.

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 peripheral blood stem cell transplantation(aPBSCT). In case of only partial remission a second identical high dose chemotherapy and aPBSCT follows. Patients with primary refractory disease or early relapse within 6 months should receive a allogenous stem cell transplantation. For Patients with CD 20 positive B-cell lymphoma the chemotherapy regiments DHAP and TEC are combined with rituximab.

Study Timeline

• Study Start: 2004-06
• Status Verified: 2006-10
• Study First Submitted: 2006-10-05
• Study First Submitted QC: 2006-10-05
• Last Update Submitted: 2006-10-05
• Study First Posted: 2006-10-06
• Last Update Posted: 2006-10-06
• Study Completion: 2010-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Toxicity

Secondary Outcome Measures

Name	Time	Method
overall survival
relapse free survival
remission rate
remission duration

Trial Locations

Locations (1)

University of Magdeburg; 🇩🇪 Magdeburg, Germany