GIMEMA LAL 0496: High-dose Anthracycline in the Induction... | NCT00439920

Studies
GIMEMA LAL 0496: High-dose Anthracycline in the Induction Regimen for the Treatment of Adult ALL.

NCT00439920

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status

Unknown status

Last Update Posted

Oct 23, 2018Actual

Enrollment

Not provided

Phase

Phase 2

Conditions

Acute Lymphoblastic Leukemia

Interventions

High-dose anthracycline

Countries

Not provided

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

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1996Actual

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Feb 23, 2007

First Submission Date that Met QC Criteria

Feb 23, 2007

First Posted Date

Feb 26, 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

Oct 22, 2018

Last Update Posted Date

Oct 23, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 aims at verifying the state of the art in what this illness concerns and at organizing a centralized samples analysis.

Detailed Description

The present trial is a prospective multicentric GIMEMA study, in which adult ALL patients are extensively analyzed at diagnosis by a multiparametric approach including CC and molecular analysis for the following gene rearrangements: BCR-ABL, MLL-AF4, E2A-PBX1, TEL-AML1, MLL, p15 and p16 deletion in order to give place to a carefully characterization of the genetic lesions occurring in adult ALL and to evaluate their prognostic significance in a large cohort of patients homogeneously treated.

This study requires a central handling and analysis of bone marrow (BM) or peripheral blood samples at presentation.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
High-dose anthracycline	Experimental		Drug: High-dose anthracycline

Name	Type	Description	Arm Group Labels	Other Names
High-dose anthracycline	Drug		High-dose anthracycline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with complete response	Patients are followed-up for response till death

Secondary Outcomes

Measure	Description	Time Frame
Number of patients that reach disease-free-survival	Patients are followed-up for response till death

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged 16-60
Diagnosed with previously untreated T-ALL and B-ALL

Exclusion Criteria:

previously treated ALL patients
L3 B-ALL

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 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, Prof.	Università degli Studi di Roma "La Sapienza"	Principal Investigator

Locations

Not provided

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
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic