Adult ALL Treatment at Diagnosis

NCT00537550 | Completed

• 1 other identifier: LAL2000
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Leukemia, Lymphocytic, Acute

Keywords

ALL; Adult

Interventions

Vincristine DRUG

Steroids pre-treatment

Vincristin, Daunorubicine, Asparaginase, Methotrexate DRUG

Induction therapy

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (5)

Az. Ospedaliera S. G. Moscati

Avellino, Italy

Location

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

Bologna, Italy

Location

Ospedale Reg. A di Summa

Brindisi, Italy

Location

Istituto di Ematologia- Ospedale San Carlo

Potenza, Italy

Location

Policlinico G.B. Rossi

Verona, 37134, Italy

Location

Related Publications (1)

• 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.

  PMID: 34048072 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Vincristine; Daunorubicin; Asparaginase; Methotrexate

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Aminopterin; Pterins; Pteridines

Study Officials

• Franco MANDELLI, Pr

  Università degli Studi di Roma "La Sapienza"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 27, 2007
• First Posted: October 1, 2007
• Study Start: July 1, 2000
• Study Completion: June 1, 2006
• Last Updated: October 1, 2007

Record last verified: 2007-09

Locations

IT (5)