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

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00384553
• Other study ID #: OSHO #071
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: October 5, 2006
• Last updated: October 5, 2006
• Start date: June 2004
• Est. completion date: June 2010

Study information

• Verified date: October 2006
• Source: University of Magdeburg
• Contact: Michael Koenigsmann, PD Dr. med
• Phone: +4939113281
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• Rituximab

• DHAP

• TEC

• autologous stem cell transplantation

Locations

Country	Name	City	State
Germany	University of Magdeburg	Magdeburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Magdeburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity
Secondary	remission rate
Secondary	remission duration
Secondary	overall survival
Secondary	relapse free survival