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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


Phase 2
18 Years
55 Years
Open (Enrolling)
Both
Mantle-Cell Lymphoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy: ORR, OS, EFS

Outcome Time Frame:

during treatment and on day 720 after allogenic SCT

Safety Issue:

Yes

Principal Investigator

Anthony D. Ho, Ph.D., Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Director of Department

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

L-149/2003

NCT ID:

NCT00946374

Start Date:

July 2004

Completion Date:

June 2011

Related Keywords:

  • Mantle-Cell Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, Mantle-Cell

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