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Prospective Trial on Immunochemotherapy Plus Autologous Stem Cell Transplantation (SCT) and Allogenic SCT in Primary Mantle-Cell-Lymphoma (HD-MCL2003)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Heidelberg University.
Recruitment status was:  Recruiting
Information provided by:
Heidelberg University Identifier:
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
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

Condition Intervention Phase
Mantle-Cell Lymphoma Drug: Immunochemotherapy Drug: High-dose BEAM plus autologous SCT Other: HLA-identical allogenic SCT Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Efficacy: ORR, OS, EFS [ Time Frame: during treatment and on day 720 after allogenic SCT ]

Secondary Outcome Measures:
  • Toxicity according to WHO-Grading [ Time Frame: During treatment and until follow-up ]
  • GvL-effect after allogenic SCT [ Time Frame: Allogenic SCT until day 720 after transplantation ]
  • Comparison of OS between patients completing the protocol and patients not receiving allogenic SCT [ Time Frame: First diagnosis of MCL until day 720 after transplantation ]

Estimated Enrollment: 20
Study Start Date: July 2004
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Immunochemotherapy
    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 Names:
    • R-CHOP
    • CHOP
    • MabThera®
    • Endoxan®
    • Cytoxan®
    • Neosar®
    • Procytox®
    • Revimmune®
    • Oncovin®
    • Adriamycin®
    • Decortin®
    • Corticosteroid
    • Steroid
    • Cellcristin®
    • CAELYX®
    • Adriblastin®
    • Doxo-Cell®
    Drug: High-dose BEAM plus autologous SCT
    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 Names:
    • BEAM
    • High-dose BEAM
    • ABSCT
    • ASCT
    • BCNU
    • Crmubris®
    • ARA-C
    • Eposin®
    • Etopophos®
    • ETO CELL®
    • Vepesid®
    • VP-16®
    • Alkeran®
    Other: HLA-identical allogenic SCT
    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 Names:
    • Sibling donor
    • Unrelated donor
    • HLA-identical
    • Conditioning regimen
    • Fludara®
    • Sandimmune®
    • Fludarabinphosphat
    • Neoflubin®
    • TBI
    • Ciclral®
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.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00946374

Contact: Markus Munder, M. D. 0049 6221 56 ext 32370

University Hospital Recruiting
Heidelberg, Germany, 69120
Contact: Markus Munder, MD         
Sponsors and Collaborators
Heidelberg University
Principal Investigator: Anthony D. Ho, Ph.D., Prof. Director of Department
  More Information

Additional Information:
Responsible Party: Prof. Dr. med. A. D. Ho, University of Heidelberg Identifier: NCT00946374     History of Changes
Other Study ID Numbers: L-149/2003
BfArM: A-7140-00-37/4021157
Study First Received: July 24, 2009
Last Updated: July 24, 2009

Keywords provided by Heidelberg University:
Non Hodgkin´s Lymphoma
High-dose chemotherapy
Autologous stem cell transplantation
Reduced conditioning regimen
Unrelated donor
Sibling donor
Total Body Irradiation
Allogenic stem cell transplantation

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin processed this record on September 21, 2017