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Trial Title:
Prospective Trial on Immunochemotherapy Plus Autologous Stem Cell Transplantation (SCT) and Allogenic SCT in Primary Mantle-Cell-Lymphoma
NCT ID:
NCT00946374
Condition:
Mantle-Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Mantle-Cell
Cyclosporine
Doxorubicin
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
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Immunochemotherapy
Description:
R-CHOP: Rituximab 375 mg/m²,intravenous ( iv ), day 0 ; Cyclophosphamide 750 mg/m²,iv,
day1; Vincristine 1,4 mg/m² but at the maximum 2 mg,iv,d1; Doxorubicin 50 mg/m², iv, d1;
Prednisone 100 mg, peroral ( po ), day 1 to day 5
Other name:
R-CHOP
Other name:
CHOP
Other name:
MabThera®
Other name:
Endoxan®
Other name:
Cytoxan®
Other name:
Neosar®
Other name:
Procytox®
Other name:
Revimmune®
Other name:
Oncovin®
Other name:
Adriamycin®
Other name:
Decortin®
Other name:
Corticosteroid
Other name:
Steroid
Other name:
Cellcristin®
Other name:
CAELYX®
Other name:
Adriblastin®
Other name:
Doxo-Cell®
Intervention type:
Drug
Intervention name:
High-dose BEAM plus autologous SCT
Description:
High-dose BEAM: Carmustine 300mg/m², iv, day -7; Cytarabine 2 x 200 mg/m², iv, day -6 to
day -3; Etoposide 2 x 100 mg/m², iv, day -6 to day -3; Melphalan 140 mg/m², iv, day -2
followed by Autologous stem cell transplantation ( > 2,5 x 10e6 CD34 positive autologous
stem cells, iv, day 0
Other name:
BEAM
Other name:
High-dose BEAM
Other name:
ABSCT
Other name:
ASCT
Other name:
BCNU
Other name:
Crmubris®
Other name:
ARA-C
Other name:
Eposin®
Other name:
Etopophos®
Other name:
ETO CELL®
Other name:
Vepesid®
Other name:
VP-16®
Other name:
Alkeran®
Intervention type:
Other
Intervention name:
HLA-identical allogenic SCT
Description:
Fludarabine 30 mg/m², iv, day -4 to day -2; Cyclosporin A 2 x 3mg/kg, iv, day -1 to day 0
plus total body irradiation with 2 Gy, day 0 followed by allogenic stem cell
transplantation immediately after Radiation.
Other name:
Sibling donor
Other name:
Unrelated donor
Other name:
HLA-identical
Other name:
Conditioning regimen
Other name:
Fludara®
Other name:
Sandimmune®
Other name:
Fludarabinphosphat
Other name:
Neoflubin®
Other name:
TBI
Other name:
Ciclral®
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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
55 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Markus Munder, MD
Start date:
July 2004
Completion date:
June 2011
Lead sponsor:
Agency:
Heidelberg University
Agency class:
Other
Source:
Heidelberg University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00946374
http://www.klinikum.uni-heidelberg.de
