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

Sponsor:	University of Heidelberg
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00946374

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 II

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:

MedlinePlus related topics: Lymphoma

Drug Information available for: Cyclophosphamide Prednisone Vincristine Fludarabine Doxorubicin Doxorubicin hydrochloride Etoposide Cyclosporine Fludarabine monophosphate Cyclosporin Etoposide phosphate Rituximab Cytarabine Melphalan Vincristine sulfate

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

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:

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®

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®

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:

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

Contacts and Locations

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

University of Heidelberg

Investigators

Principal Investigator:

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

Director of Department

More Information

Additional Information:

Homepage University hospital Heidelberg, Germany This link exits the ClinicalTrials.gov site

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 University of Heidelberg:

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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 09, 2012