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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00483132
Other study ID # GOELAL02
Secondary ID
Status Completed
Phase Phase 3
First received June 5, 2007
Last updated June 5, 2007
Start date September 1994
Est. completion date April 2002

Study information

Verified date June 2007
Source French Innovative Leukemia Organisation
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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).


Description:

Comparison between two autograf therapeutic strategies in high risk patients Ramdomised comparison between maintenance treatment with or not interferon alpha 2 a


Recruitment information / eligibility

Status Completed
Enrollment 232
Est. completion date April 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 65 Years
Eligibility Inclusion Criteria

- ALL high risk or low risk or lymphoblastic lymphoma

- age 15-55 years old

- informed consent signed

Exclusion Criteria:

- patients previously treated with a chemotherapy or alpha-interferon

- ALL 3 (burkitt like)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
interferon alpha 2a


Locations

Country Name City State
France INorbert IFRAH Angers chu ANGERS

Sponsors (1)

Lead Sponsor Collaborator
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Country where clinical trial is conducted

France, 

References & 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, Bé — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary overall survival time to death
Secondary Efficacy of study treatments time to end of treatment
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