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

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Unknown status
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Rituximab
DHAP
TEC
autologous stem cell transplantation
Sponsored by
University of Magdeburg
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MagdeburgRecruiting

Outcomes

Primary Outcome Measures

Toxicity

Secondary Outcome Measures

remission rate
remission duration
overall survival
relapse free survival

Full Information

First Posted
October 5, 2006
Last Updated
October 5, 2006
Sponsor
University of Magdeburg
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1. Study Identification

Unique Protocol Identification Number
NCT00384553
Brief Title
Risk Adapted Therapy Optimization for Patients With Relapsed or Refractory Aggressive Non-Hodgkin-Lymphoma
Official Title
Risk Adapted Therapy Optimization for Patients With Relapsed or Refractory Aggressive Non-Hodgkin-Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Unknown status
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2010 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Magdeburg

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Type
Drug
Intervention Name(s)
DHAP
Intervention Type
Drug
Intervention Name(s)
TEC
Intervention Type
Drug
Intervention Name(s)
autologous stem cell transplantation
Primary Outcome Measure Information:
Title
Toxicity
Secondary Outcome Measure Information:
Title
remission rate
Title
remission duration
Title
overall survival
Title
relapse free survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Koenigsmann, PD Dr. med
Phone
+4939113281
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Koenigsmann, PD Dr. med.
Organizational Affiliation
University of Magdeburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Magdeburg
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Koenigsmann, PD Dr. med.

12. IPD Sharing Statement

Learn more about this trial

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

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