NCT00439920

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 1996

Longer than P75 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1996

Completed
10.4 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2007

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

22.2 years

First QC Date

February 23, 2007

Last Update Submit

October 22, 2018

Conditions

Acute Lymphoblastic Leukemia

Keywords

ALL

Outcome Measures

Primary Outcomes (1)

  • Number of patients with complete response

    Patients are followed-up for response till death

Secondary Outcomes (1)

  • Number of patients that reach disease-free-survival

Study Arms (1)

High-dose anthracycline

EXPERIMENTAL
Drug: High-dose anthracycline

Interventions

High-dose anthracyclineDRUG
High-dose anthracycline

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • previously treated ALL patients
  • L3 B-ALL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 34048072DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Anthracyclines

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

NaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Franco Mandelli, Prof.

    Università degli Studi di Roma "La Sapienza"

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2007

First Posted

February 26, 2007

Study Start

October 1, 1996

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 23, 2018

Record last verified: 2018-10