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
073
Phase II Study Treatment of High Risk Non-Hodgkin's Lymphomas
2 other identifiers
interventional
45
1 country
1
Brief Summary
Phase II multicenter pilot trial (073) evaluating tandem HDT with PBSC support in aa-IPI=3 untreated aggressive NHL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 lymphoma
Started Oct 1994
Longer than P75 for phase_2 lymphoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1994
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 23, 2009
CompletedFirst Posted
Study publicly available on registry
March 25, 2009
CompletedMarch 25, 2009
March 1, 2009
4.8 years
March 23, 2009
March 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete response
end of treatment
Secondary Outcomes (1)
overall survival disease free survival
10 years after treatment
Interventions
cyclophosphamide 1200 mg/m² intravenously on day 1 (d1), epirubicin 100 mg/m² intravenously on d1, vindesine 3 mg/m² intravenously on d1 and prednisone 80 mg/m² orally or intravenously on d1-5, with two weeks intervals
The conditioning regimen of the first HDT was mitoxantrone 45 mg/m² intravenously on d1 + cytarabine 1000 mg/m² by a 3-hour infusion every 12 hours from d1-4. The conditioning regimen of the second HDT started d30 to d45 after the first stem cell infusion, and consisted of 1200 cGy total body irradiation (TBI) in 6 twice daily 200 cGy fractionated doses with a 800 cGy pulmonary shielding, followed by CBV: carmustine 300 mg/m² intravenously on d4, etoposide 200 mg/m² intravenously on d5-8 and cyclophosphamide 1500 mg/m² intravenously on d5-8.
Eligibility Criteria
You may qualify if:
- patients aged from 15 to 60 years
- previously untreated
- histologically proven aggressive NHL
- high aa-IPI (equal to 3)
- proper underlying organ function
You may not qualify if:
- transformed low-grade, lymphoblastic, mantle-cell, or Burkitt's lymphoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- French Innovative Leukemia Organisationlead
- Amgencollaborator
Study Sites (1)
Emmanuel Gyan
Tours, 37000, France
Related Publications (1)
Monjanel H, Deconinck E, Perrodeau E, Gastinne T, Delwail V, Moreau A, Francois S, Berthou C, Gyan E, Milpied N; GOELAMS. Long-term follow-up of tandem high-dose therapy with autologous stem cell support for adults with high-risk age-adjusted international prognostic index aggressive non-Hodgkin Lymphomas: a GOELAMS pilot study. Biol Blood Marrow Transplant. 2011 Jun;17(6):935-40. doi: 10.1016/j.bbmt.2010.11.017. Epub 2010 Nov 23.
PMID: 21109011DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Noël MILPIED, MDPD
French Innovative Leukemia Organisation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 23, 2009
First Posted
March 25, 2009
Study Start
October 1, 1994
Primary Completion
July 1, 1999
Study Completion
February 1, 2009
Last Updated
March 25, 2009
Record last verified: 2009-03