NCT00131027

Brief Summary

The purpose of this study is to investigate the clinical efficacy of high-dose methotrexate consolidation therapy for adult patients with BCR-ABL-negative ALL.

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
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2002

Longer than P75 for phase_3

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

September 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2005

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

November 14, 2008

Status Verified

November 1, 2008

Enrollment Period

8.5 years

First QC Date

August 15, 2005

Last Update Submit

November 13, 2008

Conditions

Lymphoblastic Leukemia, Acute

Keywords

acute lymphoblastic leukemianewly diagnosedBCR-ABL-negative

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

    3 years

Secondary Outcomes (2)

  • Toxicity

    2 years

  • The rate of complete remission

    2 months

Study Arms (2)

A

EXPERIMENTAL

HD-MTX

Drug: CyclophosphamideDrug: DaunorubicinDrug: VincristineDrug: PrednisoloneDrug: L-asparaginaseDrug: CytarabineDrug: EtoposideDrug: DexamethasoneDrug: MethotrexateDrug: MercaptopurineDrug: Doxorubicin

B

ACTIVE COMPARATOR

ID-MTX

Drug: CyclophosphamideDrug: DaunorubicinDrug: VincristineDrug: PrednisoloneDrug: L-asparaginaseDrug: CytarabineDrug: EtoposideDrug: DexamethasoneDrug: MercaptopurineDrug: DoxorubicinDrug: Methotrexate

Interventions

CyclophosphamideDRUG
AB
DaunorubicinDRUG
AB
VincristineDRUG
AB
PrednisoloneDRUG
AB
L-asparaginaseDRUG
AB
CytarabineDRUG
AB
EtoposideDRUG
AB
DexamethasoneDRUG
AB
MethotrexateDRUG

3 g/sqm (high dose)

A
MercaptopurineDRUG
AB
DoxorubicinDRUG
AB

Eligibility Criteria

Age25 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Previously untreated BCR-ABL-negative ALL
  • Age between 25 and 64 years
  • Performance status between 0 and 3 (ECOG criteria)
  • Adequate functioning of the liver (serum bilirubin level \< 2.0 mg/dL); kidneys (serum creatinine level \< 2.0 mg/dL); and heart (left ventricular ejection fraction greater than 50% and no severe abnormalities detected on electrocardiograms and echocardiographs).
  • Written informed consent to participate in the trial

You may not qualify if:

  • Uncontrolled active infection
  • Another severe and/or life-threatening disease
  • Positive for HIV antibody and/or hepatitis B surface (HBs) antigen tests
  • Another primary malignancy which is clinically active and/or requires medical interventions
  • Pregnant and/or lactating women
  • Past history of renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology, Nagoya University Graduate School of Medicine

Nagoya, 466-8550, Japan

RECRUITING

Related Links

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

CyclophosphamideDaunorubicinVincristinePrednisoloneAsparaginaseCytarabineEtoposideDexamethasoneMethotrexateMercaptopurineDoxorubicin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsAmidohydrolasesHydrolasesEnzymesEnzymes and CoenzymesCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesSteroids, FluorinatedAminopterinPterinsPteridinesSulfhydryl CompoundsSulfur CompoundsPurines

Study Officials

  • Fumihiko Hayakawa, MD

    Nagoya University

    STUDY DIRECTOR

  • Tomoki Naoe, MD

    Nagoya University

    STUDY CHAIR

Central Study Contacts

Fumihiko Hayakawa, MD

CONTACT

bun-hy@med.nagoya-u.ac.jp

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2005

First Posted

August 17, 2005

Study Start

September 1, 2002

Primary Completion

March 1, 2011

Study Completion

September 1, 2011

Last Updated

November 14, 2008

Record last verified: 2008-11

Locations

JP(1)