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

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ClinicalTrials.gov Identifier: NCT00384553
Recruitment Status : Unknown
Verified October 2006 by University of Magdeburg.
Recruitment status was:  Recruiting
First Posted : October 6, 2006
Last Update Posted : October 6, 2006
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: Rituximab Drug: DHAP Drug: TEC Drug: autologous stem cell transplantation Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Risk Adapted Therapy Optimization for Patients With Relapsed or Refractory Aggressive Non-Hodgkin-Lymphoma
Study Start Date : June 2004
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma




Primary Outcome Measures :
  1. Toxicity

Secondary Outcome Measures :
  1. remission rate
  2. remission duration
  3. overall survival
  4. relapse free survival


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384553


Contacts
Contact: Michael Koenigsmann, PD Dr. med +4939113281

Locations
Germany
University of Magdeburg Recruiting
Magdeburg, Germany, 39120
Principal Investigator: Michael Koenigsmann, PD Dr. med.         
Sponsors and Collaborators
University of Magdeburg
Investigators
Principal Investigator: Michael Koenigsmann, PD Dr. med. University of Magdeburg

ClinicalTrials.gov Identifier: NCT00384553     History of Changes
Other Study ID Numbers: OSHO #071
First Posted: October 6, 2006    Key Record Dates
Last Update Posted: October 6, 2006
Last Verified: October 2006

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents