NCT00483132

Brief Summary

Improved outcome of high risk lymphoblastic leukemia (ALL) with laite high dose therapy. High dose versus conventional therapy for adult low risk T-ALL and Lymphoblastic lymphoma (LBL).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
232

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 1994

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 1994

Completed
7.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2002

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2007

Completed
Last Updated

June 6, 2007

Status Verified

June 1, 2007

First QC Date

June 5, 2007

Last Update Submit

June 5, 2007

Conditions

Leukemia, Lymphocytic, Acute

Outcome Measures

Primary Outcomes (1)

  • overall survival

    time to death

Secondary Outcomes (1)

  • Efficacy of study treatments

    time to end of treatment

Interventions

interferon alpha 2aDRUG

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ALL high risk or low risk or lymphoblastic lymphoma
  • age 15-55 years old
  • informed consent signed

You may not qualify if:

  • patients previously treated with a chemotherapy or alpha-interferon
  • ALL 3 (burkitt like)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INorbert IFRAH

Angers, Chu Angers, 49000, France

Location

Related Publications (1)

  • Hunault M, Harousseau JL, Delain M, Truchan-Graczyk M, Cahn JY, Witz F, Lamy T, Pignon B, Jouet JP, Garidi R, Caillot D, Berthou C, Guyotat D, Sadoun A, Sotto JJ, Lioure B, Casassus P, Solal-Celigny P, Stalnikiewicz L, Audhuy B, Blanchet O, Baranger L, Bene MC, Ifrah N; GOELAMS (Groupe Ouest-Est des Leucemies Airgues et Maladies du Sang) Group. Better outcome of adult acute lymphoblastic leukemia after early genoidentical allogeneic bone marrow transplantation (BMT) than after late high-dose therapy and autologous BMT: a GOELAMS trial. Blood. 2004 Nov 15;104(10):3028-37. doi: 10.1182/blood-2003-10-3560. Epub 2004 Jul 15.

    PMID: 15256423RESULT

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Interferon alpha-2

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Interferon-alphaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Norbert IFRAH, Pr

    French Innovative Leukemia Organisation

    PRINCIPAL INVESTIGATOR

  • Noël MILPIED

    French Innovative Leukemia Organisation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 5, 2007

First Posted

June 6, 2007

Study Start

September 1, 1994

Study Completion

April 1, 2002

Last Updated

June 6, 2007

Record last verified: 2007-06

Locations

FR(1)