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Prospective Trial on Immunochemotherapy Plus Autologous Stem Cell Transplantation (SCT) and Allogenic SCT in Primary Mantle-Cell-Lymphoma
Conditions
Mantle-Cell Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Mantle-Cell
Conditions: Keywords
Mantle-Cell-Lymphoma, MCL, Non Hodgkin´s Lymphoma, NHL, Immunochemotherapy, R-CHOP, CHOP, High-dose chemotherapy, BEAM, HD-BEAM, Autologous stem cell transplantation, Reduced conditioning regimen, Unrelated donor, Sibling donor, Total Body Irradiation, TBI, Allogenic stem cell transplantation, ABSCT, ASCT, Fludarabine+TBI
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Immunochemotherapy
Type: Drug
Name: High-dose BEAM plus autologous SCT
Type: Drug
Name: HLA-identical allogenic SCT
Type: Other
Overall Status
Recruiting
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 followed by high-dose chemotherapy and autologous stem cell transplantation (SCT) and HLA-identical allogenic SCT after a dose-reduced conditioning regimen of total body irradiation (TBI) with 2 Gy and Fludarabine in younger patients with primary Mantle-Cell-Lymphoma
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 including high-dose chemotherapy plus autologous SCT show only moderate improvement of the prognosis of MCL. Allogenic SCT seems to have an immunological mechanism of action in NHL, which is commonly known as Graft-versus-Lymphoma effect. This trial´s purpose is to improve the overall survival in patients younger than 55 years with primary MCL by sequentially combining autologous SCT and allogenic SCT after the application of 6 courses of immunochemotherapy and high-dose chemotherapy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 55 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
1. First diagnosis of Mantle-Cell-Lymphoma without any previous therapies except for pre-phase treatment consisting of steroids
2. Age 18 to 55 years
3. Confirmed CD20-expression on lymphocytes
4. Effective methods of contraception and negative pregnancy test
5. Sufficient compliance
6. Written patient´s informed consent
Exclusion Criteria:
1. Manifest cardiac insufficiency, not compensated
2. Congestive Cardiomyopathy
3. Chronic pulmonary disease including hypoxemia
4. Severe hypertension, not condensable with drugs
5. Severe diabetes mellitus not condensable with drugs
6. Renal Insufficiency ( serum creatinin > 2,0 mg/dl, other than Lymphoma related)
7. Liver impairment ( Transaminases value more than 3 x upper normal value or Bilirubin > 2,0 mg/dl, other than Lymphoma related)
8. HIV-Infection
9. Active Hepatitis B-Infection if continuous virostatic treatment is not possible
10. Active Hepatitis C-Infection
11. Clinical signs of cerebrovascular insufficiency or cerebral damages
12. Pregnancy, lactation or inadequate contraception in women of childbearing age
13. Severe psychiatric disorders
14. Transplantation in the past
1. First diagnosis of Mantle-Cell-Lymphoma without any previous therapies except for pre-phase treatment consisting of steroids
2. Age 18 to 55 years
3. Confirmed CD20-expression on lymphocytes
4. Effective methods of contraception and negative pregnancy test
5. Sufficient compliance
6. Written patient´s informed consent
Exclusion Criteria:
1. Manifest cardiac insufficiency, not compensated
2. Congestive Cardiomyopathy
3. Chronic pulmonary disease including hypoxemia
4. Severe hypertension, not condensable with drugs
5. Severe diabetes mellitus not condensable with drugs
6. Renal Insufficiency ( serum creatinin > 2,0 mg/dl, other than Lymphoma related)
7. Liver impairment ( Transaminases value more than 3 x upper normal value or Bilirubin > 2,0 mg/dl, other than Lymphoma related)
8. HIV-Infection
9. Active Hepatitis B-Infection if continuous virostatic treatment is not possible
10. Active Hepatitis C-Infection
11. Clinical signs of cerebrovascular insufficiency or cerebral damages
12. Pregnancy, lactation or inadequate contraception in women of childbearing age
13. Severe psychiatric disorders
14. Transplantation in the past
Location
University Hospital
Heidelberg, Germany
Status: Recruiting
Contact: Markus Munder, MD
Start Date
July 2004
Completion Date
June 2011
Sponsors
Heidelberg University
Source
Heidelberg University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page