NCT00199017

Brief Summary

This study evaluates the efficacy and tolerability of treatment for T-lymphoblastic lymphoma (T-LBL) according to a protocol for acute lymphoblastic leukemia. Patients receive one year of intensive cyclical chemotherapy with additional prophylaxis for central nervous system (CNS) relapse by intrathecal therapy and cranial irradiation and mediastinal irradiation after induction chemotherapy.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 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

April 1, 2004

Completed
1.4 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
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Last Updated

August 23, 2010

Status Verified

May 1, 2008

Enrollment Period

4.9 years

First QC Date

September 12, 2005

Last Update Submit

August 20, 2010

Conditions

Lymphoma, Lymphoblastic

Keywords

T-LBLTreatmentDe novoChemotherapyAdultLymphoma, lymphoblastic, T-cell

Outcome Measures

Primary Outcomes (1)

  • remission rate, remission duration, disease free survival, overall survival

Secondary Outcomes (1)

  • time and dose compliance, toxicity according to World Health Organization (WHO)

Interventions

Dexamethasone/PrednisoloneDRUG
CyclophosphamideDRUG
VincristineDRUG
DaunorubicinDRUG
AsparaginaseDRUG
G-CSFDRUG
MercaptopurineDRUG
CytarabineDRUG
MethotrexateDRUG
VP16DRUG
VindesineDRUG
AdriamycinDRUG
ThioguanineDRUG
HDARACDRUG
CNS irradiationPROCEDURE
Mediastinal irradiationPROCEDURE
CladribineDRUG

Eligibility Criteria

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

You may qualify if:

  • T-lymphoblastic lymphoma (bone marrow \[BM\] involvement \< 25%)
  • Aged 15-65 years (55-65 years if biologically younger)
  • Written informed consent

You may not qualify if:

  • Severe complications due to lymphoma or secondary disease
  • T-LBL as second malignancy or other active second malignancy
  • Cytostatic pretreatment of LBL (exception of emergency treatments)
  • Pregnancy
  • Severe psychiatric illness or other circumstances which may compromise cooperation of the patient or informed consent
  • Participation in other study interfering with study treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Medical Dept. II

Frankfurt, 60590, Germany

Location

Related Links

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaLymphoma

Interventions

DexamethasonePrednisoloneCyclophosphamideVincristineDaunorubicinAsparaginaseGranulocyte Colony-Stimulating FactorMercaptopurineCytarabineMethotrexateEtoposideVindesineDoxorubicinThioguanineCladribine

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicAminoglycosidesGlycosidesCarbohydratesAmidohydrolasesHydrolasesEnzymesEnzymes and CoenzymesColony-Stimulating FactorsGlycoproteinsGlycoconjugatesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsSulfhydryl CompoundsSulfur CompoundsPurinesCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAminopterinPterinsPteridinesPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosides2-ChloroadenosineAdenosinePurine NucleosidesDeoxyadenosinesDeoxyribonucleosidesRibonucleosides

Study Officials

  • Dieter Hoelzer, MD, PhD

    University Hospital Frankfurt, Medical Dept. II

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

April 1, 2004

Primary Completion

March 1, 2009

Last Updated

August 23, 2010

Record last verified: 2008-05

Locations

DE(1)