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

Primary Purpose

Leukemia, Lymphocytic, Acute

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
interferon alpha 2a
Sponsored by
French Innovative Leukemia Organisation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Lymphocytic, Acute

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • INorbert IFRAH

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

Efficacy of study treatments

Full Information

First Posted
June 5, 2007
Last Updated
June 5, 2007
Sponsor
French Innovative Leukemia Organisation
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1. Study Identification

Unique Protocol Identification Number
NCT00483132
Brief Title
Study of Treatment High Risk and/or Low Risk Acute Lymphoblastic leukémia(ALL) Adults Stage III
Official Title
Study of Treatment High Risk and/or Low Risk Acute Lymphoblastic leukémia(ALL) Adults Stage III
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
September 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
French Innovative Leukemia Organisation

4. Oversight

Data Monitoring Committee
Yes

5. 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).
Detailed Description
Comparison between two autograf therapeutic strategies in high risk patients Ramdomised comparison between maintenance treatment with or not interferon alpha 2 a

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphocytic, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
232 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
interferon alpha 2a
Primary Outcome Measure Information:
Title
overall survival
Time Frame
time to death
Secondary Outcome Measure Information:
Title
Efficacy of study treatments
Time Frame
time to end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norbert IFRAH, Pr
Organizational Affiliation
French Innovative Leukemia Organisation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Noël MILPIED
Organizational Affiliation
French Innovative Leukemia Organisation
Official's Role
Principal Investigator
Facility Information:
Facility Name
INorbert IFRAH
City
Angers
State/Province
chu ANGERS
ZIP/Postal Code
49000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
15256423
Citation
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.
Results Reference
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Study of Treatment High Risk and/or Low Risk Acute Lymphoblastic leukémia(ALL) Adults Stage III

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