Study of Treatment High Risk and/or Low Risk Acute Lymphoblastic leukémia(ALL) Adults Stage III

Sponsor

French Innovative Leukemia Organisation (Other)

Overall Status

Completed

CT.gov ID

NCT00483132

Collaborator

(none)

232

Enrollment

Location

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Lymphocytic, Acute	Drug: interferon alpha 2a	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

232 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Study of Treatment High Risk and/or Low Risk Acute Lymphoblastic leukémia(ALL) Adults Stage III

Study Start Date :

Sep 1, 1994

Actual Study Completion Date :

Apr 1, 2002

Outcome Measures

Primary Outcome Measures

overall survival [time to death]

Secondary Outcome Measures

Efficacy of study treatments [time to end of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	INorbert IFRAH	Angers	chu ANGERS	France	49000

Sponsors and Collaborators

French Innovative Leukemia Organisation

Investigators

Principal Investigator: Norbert IFRAH, Pr, French Innovative Leukemia Organisation
Principal Investigator: Noël MILPIED, French Innovative Leukemia Organisation