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)
• Enrollment: 45
• Location: 1
• Duration (Months): 172.1
• Patients Per Site Per Month: 0.3

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
Lymphoma	Drug: CEEP regimen; Procedure: Tandem high-dose therapy (HDT) followed by autologous peripheral blood stem cell (PBSC)	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

1. Complete response [end of treatment]

Secondary Outcome Measures

1. 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.

• 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 , ,: High-dose chemotherapy; aggressive NHL; high-risk; PBSC
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin

Study Results

No Results Posted as of Mar 25, 2009