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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non-Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: Rituximab
* Drug: DHAP
* Drug: TEC
* Drug: autologous stem cell transplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rituximab|nan|
|Drug: DHAP|nan|
|Drug: TEC|nan|
|Drug: autologous stem cell transplantation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remission rate |  |  | 
| remission duration |  |  | 
| overall survival |  |  | 
| relapse free survival |  |  |