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

Phase 2

• Conditions: Mantle-Cell Lymphoma

• Registration Number: NCT00946374
• Lead Sponsor: Heidelberg University

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.

Study Timeline

• Study Start: 2004-07
• Status Verified: 2009-07
• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-07-24
• Last Update Submitted: 2009-07-24
• Study First Posted: 2009-07-27
• Last Update Posted: 2009-07-27
• Primary Completion: 2010-12
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacy: ORR, OS, EFS	during treatment and on day 720 after allogenic SCT

Secondary Outcome Measures

Name	Time	Method
Toxicity according to WHO-Grading	During treatment and until follow-up
GvL-effect after allogenic SCT	Allogenic SCT until day 720 after transplantation
Comparison of OS between patients completing the protocol and patients not receiving allogenic SCT	First diagnosis of MCL until day 720 after transplantation

Trial Locations

Locations (1)

University Hospital; 🇩🇪 Heidelberg, Germany