073: Long-Term Follow-up of Tandem High-Dose Therapy With Peripheral Blood Stem Cell for Adults With High-Risk Age-Adjusted IPI Aggressive Non-Hodgkin's Lymphomas
Sponsor
French Innovative Leukemia Organisation (Other)
Overall Status
Completed
CT.gov ID
NCT00869284
Collaborator
Amgen (Industry)
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172.1
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Study Details
Study Description
Brief Summary
Phase II multicenter pilot trial (073) evaluating tandem HDT with PBSC support in aa-IPI=3 untreated aggressive NHL.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
High-dose chemotherapy; untreated aggressive non-Hodgkin's lymphoma; high-risk; peripheral blood stem cell support Patients were aged from 15 to 60 years
Study Design
Study Type:
Interventional
Actual Enrollment
:
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study Treatment of High Risk Non-Hodgkin's Lymphomas
Study Start Date
:
Oct 1, 1994
Actual Primary Completion Date
:
Jul 1, 1999
Actual Study Completion Date
:
Feb 1, 2009
Outcome Measures
Primary Outcome Measures
- Complete response [end of treatment]
Secondary Outcome Measures
- overall survival disease free survival [10 years after treatment]
Eligibility Criteria
Criteria
Ages Eligible for Study:
15 Years
to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
patients aged from 15 to 60 years
-
previously untreated
-
histologically proven aggressive NHL
-
high aa-IPI (equal to 3)
-
proper underlying organ function
Exclusion Criteria:
- transformed low-grade, lymphoblastic, mantle-cell, or Burkitt's lymphoma
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Emmanuel Gyan | Tours | France | 37000 |
Sponsors and Collaborators
- French Innovative Leukemia Organisation
- Amgen
Investigators
- Principal Investigator: Noël MILPIED, MDPD, French Innovative Leukemia Organisation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00869284
Other Study ID Numbers:
- GOELAMS 073
- no other identification number
First Posted:
Mar 25, 2009
Last Update Posted:
Mar 25, 2009
Last Verified:
Mar 1, 2009
Keywords provided by ,
,
Additional relevant MeSH terms: