NCT00199082

Brief Summary

The study evaluates the efficacy and tolerability of alternating short cycles of high-dose and conventional chemotherapy in combination with rituximab in CD20 positive patients, followed by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. A dose-reduced regimen is offered for patients estimated to be over 55 years, biologically.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
650

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

August 19, 2022

Status Verified

August 1, 2022

Enrollment Period

7.9 years

First QC Date

September 12, 2005

Last Update Submit

August 17, 2022

Conditions

Burkitt's LymphomaBurkitt's LeukemiaMediastinal NeoplasmsLymphoblastic LymphomaLarge Cell Anaplastic Lymphoma

Keywords

High-grade NHLDe novoMature B-ALLBurkitt'S NHLChemotherapyRituximabPrimary mediastinal diffuse large cell lymphomaB-precursor lymphoblastic lymphoma

Outcome Measures

Primary Outcomes (4)

  • Remission rate

  • Remission duration

  • Disease free survival

  • Overall survival

Secondary Outcomes (4)

  • Dose and time compliance

  • Toxicity according to National Cancer Institute (NCI)-Common Toxicity Criteria (CTC)

  • Death under therapy and in complete remission (CR)

  • Localisations of relapse

Study Arms (1)

Experimental

EXPERIMENTAL

This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement

Drug: AdriamycinDrug: CyclophosphamideDrug: CytarabineDrug: Dexamethasone/PrednisoloneDrug: VP16Drug: IfosfamideDrug: MethotrexateDrug: G-CSFDrug: RituximabDrug: Vincristine/VindesineProcedure: Irradiation (in specific conditions)

Interventions

AdriamycinDRUG
Experimental
CyclophosphamideDRUG
Experimental
CytarabineDRUG
Experimental
Dexamethasone/PrednisoloneDRUG
Experimental
VP16DRUG
Experimental
IfosfamideDRUG
Experimental
MethotrexateDRUG
Experimental
G-CSFDRUG
Experimental
RituximabDRUG
Experimental
Vincristine/VindesineDRUG
Experimental
Irradiation (in specific conditions)PROCEDURE
Experimental

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Burkitt's leukemia or Burkitt's lymphoma or primary mediastinal large B-cell lymphoma or B-precursor lymphoblastic lymphoma or large cell anaplastic lymphoma
  • Age \> 15 years
  • Written informed consent

You may not qualify if:

  • Serious secondary diseases, including psychiatric conditions, under which the required therapy compliance is not to be expected
  • HIV infection
  • Secondary lymphoma following prior chemotherapy/radiotherapy or active second malignancy
  • Known severe allergy to foreign proteins
  • Pre-treatment other than 1 cycle CHOP or similar; \< 1 week of another chemotherapy.
  • Pregnancy or nursing
  • Participation in other studies that interfere with study therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Medical Dept. II

Frankfurt, 60590, Germany

Location

Related Publications (1)

  • Hoelzer D, Walewski J, Dohner H, Viardot A, Hiddemann W, Spiekermann K, Serve H, Duhrsen U, Huttmann A, Thiel E, Dengler J, Kneba M, Schaich M, Schmidt-Wolf IG, Beck J, Hertenstein B, Reichle A, Domanska-Czyz K, Fietkau R, Horst HA, Rieder H, Schwartz S, Burmeister T, Gokbuget N; German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia. Improved outcome of adult Burkitt lymphoma/leukemia with rituximab and chemotherapy: report of a large prospective multicenter trial. Blood. 2014 Dec 18;124(26):3870-9. doi: 10.1182/blood-2014-03-563627. Epub 2014 Oct 30.

    PMID: 25359988RESULT

MeSH Terms

Conditions

Burkitt LymphomaMediastinal NeoplasmsPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, Large-Cell, Anaplastic

Interventions

DoxorubicinCyclophosphamideCytarabineDexamethasonePrednisoloneEtoposideIfosfamideMethotrexateGranulocyte Colony-Stimulating FactorRituximabVincristineVindesineRadiation

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesThoracic NeoplasmsNeoplasms by SiteMediastinal DiseasesThoracic DiseasesRespiratory Tract DiseasesLeukemia, LymphoidLeukemiaHematologic DiseasesLymphoma, T-Cell

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsSteroids, FluorinatedPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesOxazinesAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingColony-Stimulating FactorsGlycoproteinsGlycoconjugatesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsSerum GlobulinsGlobulinsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesIndolizidinesIndolizinesPhysical Phenomena

Study Officials

  • Nicola Goekbuget, Dr. med.

    University Hospital of Frankfurt (Main)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Study Coordinator

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

July 1, 2002

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

August 19, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)