Clinical trial NCT00946374: Prospective Trial on Immunochemotherapy Plus Autologous Stem Cell Transplantation (SCT) and Allogenic SCT in Primary Mantle-Cell-Lymphoma
Official title: A Prospective Phase II Trial on R-CHOP Followed by High-dose BEAM and Autologous SCT and HLA-identical Allogenic SCT After Dose-reduced Conditioning in Patients Age < 55 Years With Primary Mantle-Cell-Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Mantle-Cell Lymphoma
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
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2009-07-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: Efficacy: ORR, OS, EFS
timeFrame: during treatment and on day 720 after allogenic SCT
Secondary outcomes:
measure: Toxicity according to WHO-Grading
timeFrame: During treatment and until follow-up
measure: GvL-effect after allogenic SCT
timeFrame: Allogenic SCT until day 720 after transplantation
measure: Comparison of OS between patients completing the protocol and patients not receiving allogenic SCT
timeFrame: First diagnosis of MCL until day 720 after transplantation
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital
Study officials:
affiliation: Director of Department
name: Anthony D. Ho, Ph.D., Prof.
role: PRINCIPAL_INVESTIGATOR
References: