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

October 5, 2006 updated by: University of Magdeburg
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Magdeburg, Germany, 39120
        • Recruiting
        • University of Magdeburg
        • Principal Investigator:
          • Michael Koenigsmann, PD Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Toxicity

Secondary Outcome Measures

Outcome Measure
overall survival
relapse free survival
remission rate
remission duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Magdeburg

Investigators

  • Principal Investigator: Michael Koenigsmann, PD Dr. med., University of Magdeburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion

June 1, 2010

Study Registration Dates

First Submitted

October 5, 2006

First Submitted That Met QC Criteria

October 5, 2006

First Posted (Estimate)

October 6, 2006

Study Record Updates

Last Update Posted (Estimate)

October 6, 2006

Last Update Submitted That Met QC Criteria

October 5, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSHO #071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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