Status:
UNKNOWN
Prospective Trial on Immunochemotherapy Plus Autologous Stem Cell Transplantation (SCT) and Allogenic SCT in Primary Mantle-Cell-Lymphoma
Lead Sponsor:
Heidelberg University
Conditions:
Mantle-Cell Lymphoma
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to improve the overall survival of Mantle-Cell-Lymphoma (MCL) by a new concept of treatment with primary curative intention consisting of six courses of immunochemotherapy...
Detailed Description
With a median overall survival of approximately 3 years, MCL has the poorest prognosis of all NHL entities. No potentially curative therapy has been established yet as even more intensive therapies in...
Eligibility Criteria
Inclusion
- First diagnosis of Mantle-Cell-Lymphoma without any previous therapies except for pre-phase treatment consisting of steroids
- Age 18 to 55 years
- Confirmed CD20-expression on lymphocytes
- Effective methods of contraception and negative pregnancy test
- Sufficient compliance
- Written patient´s informed consent
Exclusion
- Manifest cardiac insufficiency, not compensated
- Congestive Cardiomyopathy
- Chronic pulmonary disease including hypoxemia
- Severe hypertension, not condensable with drugs
- Severe diabetes mellitus not condensable with drugs
- Renal Insufficiency ( serum creatinin \> 2,0 mg/dl, other than Lymphoma related)
- Liver impairment ( Transaminases value more than 3 x upper normal value or Bilirubin \> 2,0 mg/dl, other than Lymphoma related)
- HIV-Infection
- Active Hepatitis B-Infection if continuous virostatic treatment is not possible
- Active Hepatitis C-Infection
- Clinical signs of cerebrovascular insufficiency or cerebral damages
- Pregnancy, lactation or inadequate contraception in women of childbearing age
- Severe psychiatric disorders
- Transplantation in the past
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00946374
Start Date
July 1 2004
End Date
June 1 2011
Last Update
July 27 2009
Active Locations (1)
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1
University Hospital
Heidelberg, Germany, 69120