NCT00199069

Brief Summary

The study evaluates the efficacy and tolerability of a risk- and subtype-adapted chemotherapy over one year, followed by randomized either intensified or conventional maintenance therapy. It includes a distinct protocol for the subgroup 'mature B-ALL',

Trial Health

87
On Track

Trial Health Score

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

Enrollment
720

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 1993

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

April 1, 1993

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 1999

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2001

Completed
4.4 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
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

5.8 years

First QC Date

September 12, 2005

Last Update Submit

March 15, 2023

Conditions

Adult Acute Lymphocytic Leukemia

Keywords

ALLTreatmentDe NovoAdult

Outcome Measures

Primary Outcomes (1)

  • remission rate, disease free survival, overall survival

Secondary Outcomes (1)

  • death in induction, toxicity, time and dose compliance

Interventions

AsparaginaseDRUG
VincristineDRUG
Daunorubicin, AdriamycinDRUG
CyclophosphamideDRUG
IfosfamideDRUG
CytarabineDRUG
MitoxantroneDRUG
MethotrexateDRUG
6-MercaptopurineDRUG
6-ThioguanineDRUG
VM26DRUG
Dexamethasone / PrednisoloneDRUG
CNS IrradiationPROCEDURE
Mediastinal IrradiationPROCEDURE
Stem Cell TransplantationPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Acute Lymphocytic Leukemia
  • Age 15 - 65 years

You may not qualify if:

  • Serious secondary diseases which may compromise intensified chemotherapeutical treatment
  • Serious psychiatric diseases, which may compromise compliance with therapy
  • HIV-1 or HIV-2 Infection
  • Pretreatment \> 2 weeks or chemotherapy other than Vincristine and Steroids
  • Patients without central diagnosis who cannot be allocated to a risk group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Medical Dept. II

Frankfurt, Germany

Location

Related Links

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

AsparaginaseVincristineDaunorubicinDoxorubicinCyclophosphamideIfosfamideCytarabineMitoxantroneMethotrexateMercaptopurineThioguanineTeniposideDexamethasonePrednisoloneStem Cell Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AmidohydrolasesHydrolasesEnzymesEnzymes and CoenzymesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingCytidinePyrimidine NucleosidesPyrimidinesArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAnthraquinonesAnthronesAnthracenesQuinonesAminopterinPterinsPteridinesSulfhydryl CompoundsSulfur CompoundsPurinesGlucosidesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsSteroids, FluorinatedCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Dieter Hoelzer, MD, PhD

    University of Frankfurt, Medical Department II

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Coordinator

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

April 1, 1993

Primary Completion

January 1, 1999

Study Completion

May 1, 2001

Last Updated

March 17, 2023

Record last verified: 2023-03

Locations

DE(1)