NCT00946374

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 27, 2009

Status Verified

July 1, 2009

Enrollment Period

6.4 years

First QC Date

July 24, 2009

Last Update Submit

July 24, 2009

Conditions

Mantle-Cell Lymphoma

Keywords

Mantle-Cell-LymphomaMCLNon Hodgkin´s LymphomaNHLImmunochemotherapyR-CHOPCHOPHigh-dose chemotherapyBEAMHD-BEAMAutologous stem cell transplantationReduced conditioning regimenUnrelated donorSibling donorTotal Body IrradiationTBIAllogenic stem cell transplantationABSCTASCTFludarabine+TBI

Outcome Measures

Primary Outcomes (1)

  • Efficacy: ORR, OS, EFS

    during treatment and on day 720 after allogenic SCT

Secondary Outcomes (3)

  • 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

Interventions

ImmunochemotherapyDRUG

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

Also known as: R-CHOP, CHOP, MabThera®, Endoxan®, Cytoxan®, Neosar®, Procytox®, Revimmune®, Oncovin®, Adriamycin®, Decortin®, Corticosteroid, Steroid, Cellcristin®, CAELYX®, Adriblastin®, Doxo-Cell®
High-dose BEAM plus autologous SCTDRUG

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

Also known as: BEAM, High-dose BEAM, ABSCT, ASCT, BCNU, Crmubris®, ARA-C, Eposin®, Etopophos®, ETO CELL®, Vepesid®, VP-16®, Alkeran®
HLA-identical allogenic SCTOTHER

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.

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

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Heidelberg, 69120, Germany

RECRUITING

Related Links

MeSH Terms

Conditions

Lymphoma, Mantle-CellLymphoma, Non-Hodgkin

Interventions

R-CHOP protocolRituximabCyclophosphamideVincristineDoxorubicinPrednisoneAdrenal Cortex HormonesSteroidsliposomal doxorubicinCarmustineCytarabineEtoposideetoposide phosphateMelphalanTransplantation Conditioningfludarabine phosphateCyclosporine

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPregnadienediolsPregnadienesPregnanesFused-Ring CompoundsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNitrosourea CompoundsUreaAmidesNitroso CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsImmunosuppression TherapyImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesCyclosporinsPeptides, CyclicMacrocyclic CompoundsPeptides

Study Officials

  • Anthony D. Ho, Ph.D., Prof.

    Director of Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Markus Munder, M. D.

CONTACT

0049 6221 56markus.munder@med.uni-heidelberg.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 27, 2009

Study Start

July 1, 2004

Primary Completion

December 1, 2010

Study Completion

June 1, 2011

Last Updated

July 27, 2009

Record last verified: 2009-07

Locations

DE(1)