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Adult ALL Treatment at Diagnosis (LAL2000)

Primary Purpose

Leukemia, Lymphocytic, Acute

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Vincristine
Vincristin, Daunorubicine, Asparaginase, Methotrexate
Sponsored by
Gruppo Italiano Malattie EMatologiche dell'Adulto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Lymphocytic, Acute focused on measuring ALL, Adult

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Az. Ospedaliera S. G. Moscati
  • Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
  • Ospedale Reg. A di Summa
  • Istituto di Ematologia- Ospedale San Carlo
  • Policlinico G.B. Rossi

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 27, 2007
Last Updated
September 28, 2007
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
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1. Study Identification

Unique Protocol Identification Number
NCT00537550
Brief Title
Adult ALL Treatment at Diagnosis
Acronym
LAL2000
Official Title
GIMEMA Guidelines for the Treatment of Adult ALL Affected Patients at Diagnosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphocytic, Acute
Keywords
ALL, Adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Steroids pre-treatment
Intervention Type
Drug
Intervention Name(s)
Vincristin, Daunorubicine, Asparaginase, Methotrexate
Intervention Description
Induction therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco MANDELLI, Pr
Organizational Affiliation
Università degli Studi di Roma "La Sapienza"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Az. Ospedaliera S. G. Moscati
City
Avellino
Country
Italy
Facility Name
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
City
Bologna
Country
Italy
Facility Name
Ospedale Reg. A di Summa
City
Brindisi
Country
Italy
Facility Name
Istituto di Ematologia- Ospedale San Carlo
City
Potenza
Country
Italy
Facility Name
Policlinico G.B. Rossi
City
Verona
ZIP/Postal Code
37134
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
34048072
Citation
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.
Results Reference
derived

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Adult ALL Treatment at Diagnosis

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