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

Primary Purpose

Mantle-Cell Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Immunochemotherapy

High-dose BEAM plus autologous SCT

HLA-identical allogenic SCT

About this trial

This is an interventional treatment trial for Mantle-Cell Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

First diagnosis of Mantle-Cell-Lymphoma without any previous therapies except for pre-phase treatment consisting of steroids
Age 18 to 55 years
Confirmed CD20-expression on lymphocytes
Effective methods of contraception and negative pregnancy test
Sufficient compliance
Written patient´s informed consent

Exclusion Criteria:

Manifest cardiac insufficiency, not compensated
Congestive Cardiomyopathy
Chronic pulmonary disease including hypoxemia
Severe hypertension, not condensable with drugs
Severe diabetes mellitus not condensable with drugs
Renal Insufficiency ( serum creatinin > 2,0 mg/dl, other than Lymphoma related)
Liver impairment ( Transaminases value more than 3 x upper normal value or Bilirubin > 2,0 mg/dl, other than Lymphoma related)
HIV-Infection
Active Hepatitis B-Infection if continuous virostatic treatment is not possible
Active Hepatitis C-Infection
Clinical signs of cerebrovascular insufficiency or cerebral damages
Pregnancy, lactation or inadequate contraception in women of childbearing age
Severe psychiatric disorders
Transplantation in the past

Sites / Locations

University HospitalRecruiting

Outcomes

Primary Outcome Measures

Efficacy: ORR, OS, EFS

Secondary Outcome Measures

Toxicity according to WHO-Grading

GvL-effect after allogenic SCT

Comparison of OS between patients completing the protocol and patients not receiving allogenic SCT

Full Information

NCT ID

NCT00946374

First Posted

July 24, 2009

Last Updated

July 24, 2009

Sponsor

Heidelberg University

1. Study Identification

Unique Protocol Identification Number

NCT00946374

Brief Title

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

Acronym

HD-MCL2003

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Unknown status

Study Start Date

July 2004 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Heidelberg University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mantle-Cell Lymphoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Immunochemotherapy

Other Intervention Name(s)

R-CHOP, CHOP, MabThera®, Endoxan®, Cytoxan®, Neosar®, Procytox®, Revimmune®, Oncovin®, Adriamycin®, Decortin®, Corticosteroid, Steroid, Cellcristin®, CAELYX®, Adriblastin®, Doxo-Cell®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

High-dose BEAM plus autologous SCT

Other Intervention Name(s)

BEAM, High-dose BEAM, ABSCT, ASCT, BCNU, Crmubris®, ARA-C, Eposin®, Etopophos®, ETO CELL®, Vepesid®, VP-16®, Alkeran®

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

HLA-identical allogenic SCT

Other Intervention Name(s)

Sibling donor, Unrelated donor, HLA-identical, Conditioning regimen, Fludara®, Sandimmune®, Fludarabinphosphat, Neoflubin®, TBI, Ciclral®

Intervention Description

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.

Primary Outcome Measure Information:

Title

Efficacy: ORR, OS, EFS

Time Frame

during treatment and on day 720 after allogenic SCT

Secondary Outcome Measure Information:

Title

Toxicity according to WHO-Grading

Time Frame

During treatment and until follow-up

Title

GvL-effect after allogenic SCT

Time Frame

Allogenic SCT until day 720 after transplantation

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: First diagnosis of Mantle-Cell-Lymphoma without any previous therapies except for pre-phase treatment consisting of steroids Age 18 to 55 years Confirmed CD20-expression on lymphocytes Effective methods of contraception and negative pregnancy test Sufficient compliance Written patient´s informed consent Exclusion Criteria: Manifest cardiac insufficiency, not compensated Congestive Cardiomyopathy Chronic pulmonary disease including hypoxemia Severe hypertension, not condensable with drugs Severe diabetes mellitus not condensable with drugs Renal Insufficiency ( serum creatinin > 2,0 mg/dl, other than Lymphoma related) Liver impairment ( Transaminases value more than 3 x upper normal value or Bilirubin > 2,0 mg/dl, other than Lymphoma related) HIV-Infection Active Hepatitis B-Infection if continuous virostatic treatment is not possible Active Hepatitis C-Infection Clinical signs of cerebrovascular insufficiency or cerebral damages Pregnancy, lactation or inadequate contraception in women of childbearing age Severe psychiatric disorders Transplantation in the past

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Markus Munder, M. D.

Phone

0049 6221 56

Ext

32370

markus.munder@med.uni-heidelberg.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Director of Department

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Markus Munder, MD

12. IPD Sharing Statement

Links:

URL

http://www.klinikum.uni-heidelberg.de

Description

Homepage University hospital Heidelberg, Germany

Learn more about this trial

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

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