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CompletedNCT00537550LAL2000Updated Oct 1, 2007

Adult ALL Treatment at Diagnosis

An interventional study of Vincristine and Vincristin, Daunorubicine, Asparaginase, Methotrexate in Leukemia, Lymphocytic, Acute, sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto. Completed at 5 sites in Italy. Open to participants aged 14 Years to 60 Years. Per ClinicalTrials.gov, last updated 2007-10-01.

Sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Allocation
Not applicable
Ages
14 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Leukemia, Lymphocytic, Acute

Keywords

  • ALL
  • Adult
03

In context

Leukemia, Lymphoid

1,780 studies on the registry are indexed under Leukemia, Lymphoid; 176 are open to participants now.

Browse Leukemia, Lymphoid studies →

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto is the lead sponsor of 132 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)

Interventions

  • DrugVincristine

    Steroids pre-treatment

  • DrugVincristin, Daunorubicine, Asparaginase, Methotrexate

    Induction therapy

06

Study locations

5 sites
  • Az. Ospedaliera S. G. Moscati
    Avellino, Italy
  • Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
    Bologna, Italy
  • Ospedale Reg. A di Summa
    Brindisi, Italy
  • Istituto di Ematologia- Ospedale San Carlo
    Potenza, Italy
  • Policlinico G.B. Rossi
    Verona, 37134, Italy
07

References and documents

Publications

  • 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. PubMed 34048072 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00537550
Lead sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
First posted
Oct 1, 2007
Start date
Jul 2000
Completion
Jun 2006
Last update
Oct 1, 2007

Study contacts

Franco MANDELLI, Pr
principal investigator · Università degli Studi di Roma "La Sapienza"

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.

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