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

July 24, 2009 updated by: Heidelberg University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • Recruiting
        • University Hospital
        • Contact:
          • Markus Munder, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy: ORR, OS, EFS
Time Frame: during treatment and on day 720 after allogenic SCT
during treatment and on day 720 after allogenic SCT

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity according to WHO-Grading
Time Frame: During treatment and until follow-up
During treatment and until follow-up
GvL-effect after allogenic SCT
Time Frame: Allogenic SCT until day 720 after transplantation
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
First diagnosis of MCL until day 720 after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

  • Principal Investigator: Anthony D. Ho, Ph.D., Prof., director of department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

July 24, 2009

First Submitted That Met QC Criteria

July 24, 2009

First Posted (Estimate)

July 27, 2009

Study Record Updates

Last Update Posted (Estimate)

July 27, 2009

Last Update Submitted That Met QC Criteria

July 24, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L-149/2003
  • BfArM: A-7140-00-37/4021157

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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