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Clinical Trials/NCT00869284
NCT00869284CompletedPhase 2

Phase II Study Treatment of High Risk Non-Hodgkin's Lymphomas

French Innovative Leukemia Organisation2 sites in 1 country45 target enrollmentStarted: October 1, 1994Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
45
Locations
2
Primary Endpoint
Complete response
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Phase II multicenter pilot trial (073) evaluating tandem HDT with PBSC support in aa-IPI=3 untreated aggressive NHL.

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
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
15 Years to 60 Years (Child, Adult)
Sex
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

Outcomes

Primary Outcomes

Complete response

Time Frame: end of treatment

Secondary Outcomes

  • overall survival disease free survival(10 years after treatment)

Investigators

Sponsor
French Innovative Leukemia Organisation
Sponsor Class
Other

Study Sites (2)

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