Adult ALL Treatment at Diagnosis | NCT00537550

Studies
Adult ALL Treatment at Diagnosis

NCT00537550

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status

Completed

Last Update Posted

Oct 1, 2007Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Leukemia, Lymphocytic, Acute

Interventions

Vincristine
Vincristin, Daunorubicine, Asparaginase, Methotrexate

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2000

Primary Completion Date

Not provided

Completion Date

Jun 2006Actual

First Submitted Date

Sep 27, 2007

First Submission Date that Met QC Criteria

Sep 28, 2007

First Posted Date

Oct 1, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2007

Last Update Posted Date

Oct 1, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vincristine	Drug	Steroids pre-treatment
Vincristin, Daunorubicine, Asparaginase, Methotrexate	Drug	Induction therapy

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Franco MANDELLI, Pr	Università degli Studi di Roma "La Sapienza"	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Az. Ospedaliera S. G. Moscati		Avellino			Italy
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34048072	Derived	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.

ID	Term
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D014748	Vinca Alkaloids
D046948	Secologanin Tryptamine Alkaloids
D026121	Indole Alkaloids
D000470	Alkaloids

ID	Term
D014750	Vincristine
D003630	Daunorubicin
D001215	Asparaginase
D008727	Methotrexate