Adult ALL Treatment at Diagnosis

NCT ID: NCT00537550

Last Updated: 2007-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Study Completion Date

2006-06-30

Brief Summary

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The present study has been designed to give participating centers the possibility of better understanding the diagnostic and prognostic factors of ALL patients.

Detailed Description

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Conditions

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Leukemia, Lymphocytic, Acute

Keywords

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ALL Adult

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Vincristine

Steroids pre-treatment

Intervention Type DRUG

Vincristin, Daunorubicine, Asparaginase, Methotrexate

Induction therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of acute lymphoblastic leukemia (ALL)
* Negative myeloperoxidase stain
* Phenotype T (ALL-T) and B(ALL-B)

Exclusion Criteria

* Creatinine \> 2.5mg/dL after adequate hydratation
* LVEF \<50%
* Presence of documented infections not responding to antibiotic and/or antifungal therapy
* Presence of concomitant malignant diseases
* Absence of any psychological condition that does not allow to intake high doses of cortisone
* Patients who have received any antineoplastic chemiotherapy for more than 5 days
* Patients who have received any steroids for more than 10 days
Minimum Eligible Age

14 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role lead

Principal Investigators

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Franco MANDELLI, Pr

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Roma "La Sapienza"

Locations

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Az. Ospedaliera S. G. Moscati

Avellino, , Italy

Site Status

Ist.Ematologia e Oncologia Medica L.e A. Seragnoli

Bologna, , Italy

Site Status

Ospedale Reg. A di Summa

Brindisi, , Italy

Site Status

Istituto di Ematologia- Ospedale San Carlo

Potenza, , Italy

Site Status

Policlinico G.B. Rossi

Verona, , Italy

Site Status

Countries

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Italy

References

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Piciocchi A, Messina M, Elia L, Vitale A, Soddu S, Testi AM, Chiaretti S, Mancini M, Albano F, Spadano A, Krampera M, Bonifacio M, Cairoli R, Vetro C, Colella F, Ferrara F, Cimino G, Bassan R, Fazi P, Vignetti M. Prognostic impact of KMT2A-AFF1-positivity in 926 BCR-ABL1-negative B-lineage acute lymphoblastic leukemia patients treated in GIMEMA clinical trials since 1996. Am J Hematol. 2021 Sep 1;96(9):E334-E338. doi: 10.1002/ajh.26253. Epub 2021 Jun 9. No abstract available.

Reference Type DERIVED
PMID: 34048072 (View on PubMed)

Other Identifiers

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LAL2000

Identifier Type: -

Identifier Source: org_study_id