Overview

Prospective Trial on Immunochemotherapy Plus Autologous Stem Cell Transplantation (SCT) and Allogenic SCT in Primary Mantle-Cell-Lymphoma

Status:
Unknown status
Trial end date:
2011-06-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Heidelberg University
Treatments:
Cyclosporine
Doxorubicin
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