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 because the information has not been verified recently.
Verified July 2009 by Heidelberg University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00946374
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity according to WHO-Grading [ Time Frame: During treatment and until follow-up ] [ Designated as safety issue: Yes ]
  • GvL-effect after allogenic SCT [ Time Frame: Allogenic SCT until day 720 after transplantation ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

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
    • Immunochemotherapy
    • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946374

Contacts
Contact: Markus Munder, M. D. 0049 6221 56 ext 32370 markus.munder@med.uni-heidelberg.de

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

Additional Information:
No publications provided

Responsible Party: Prof. Dr. med. A. D. Ho, University of Heidelberg
ClinicalTrials.gov 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
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heidelberg University:
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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Doxorubicin
Vincristine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 01, 2014