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NCT00137995 · ClinicalTrials.gov registry record · Phase 3
R-ICE Versus R-DHAP in Patients Aged 18-65 With Relapse Diffuse Large B-cell Lymphoma
A Phase 3 study of Lymphoma, Large-Cell, Diffuse, sponsored by Lymphoma Study Association.
- Completed
- Registry status
- Phase 3
- Development phase
- 481
- Enrollment target
- 10
- Study locations
NCT00137995 is a Phase 3 study of Lymphoma, Large-Cell, Diffuse that has completed, run by Lymphoma Study Association. The registered enrollment target is 481 participants. The trial reports 10 study locations across 2 states.
The verdict
NCT00137995, a Phase 3 study of Lymphoma, Large-Cell, Diffuse, has completed, sponsored by Lymphoma Study Association.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 481 participants
- Enrollment target
- 10
- Study locations
Study Summary
The primary objective of this study is to evaluate the efficacy and safety of induction therapy R-ICE in comparison to R-DHAP after 3 cycles adjusted to successful mobilization of stem cells in patients with previously treated diffuse large B-cell lymphoma CD20. The goal is to detect a difference in mobilization adjusted response rate of 15% between R-ICE and R-DHAP. The other objective is to evaluate the efficacy and safety of MabThera maintenance therapy after transplantation as measured by the event free survival. The goal is to obtain a 15% increase of event free survival at 2 years.
Conditions Studied
Interventions
- DRUG Rituximab
- DRUG Etoposide
- DRUG Carboplatine
- DRUG Ifosfamide + Mesna
- DRUG Cisplatine
Study Locations (10)
Other
- Australian leukemia and lymphoma group - Sydney
- Groupe d'atude des lymphome de l'adulte - Yvoir
- Czech Lymphoma study group - Prague
- Hospital district of south west Finland - Turku
- German high grade non hodgkin's lymphoma group - Hamburg
- Israel Society of Hematology - Tel Litwinsky
- Nordic center - Uppsala
- Schweirische Arbeitsgruppe fur klinische Krebsforschung - Lausanne
- National cancer research institute - London
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 481 participants |
| Start Date | 2003-06 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00137995
The ClinicalTrials.gov registry entry for NCT00137995 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 481 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lymphoma Study Association, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lymphoma, Large-Cell, Diffuse appearing as the primary indexed condition, and to 5 interventions - of which Rituximab is the first listed.
NCT00137995 reports 10 study locations spanning 2 distinct geographic areas - top geographies include Other, New York.
Frequently Asked Questions
What is clinical trial NCT00137995 about?
NCT00137995 is a clinical study titled "R-ICE Versus R-DHAP in Patients Aged 18-65 With Relapse Diffuse Large B-cell Lymphoma". The primary objective of this study is to evaluate the efficacy and safety of induction therapy R-ICE in comparison to R-DHAP after 3 cycles adjusted to successful mobilization of stem cells in patients with previously treated diffuse large B-cell lymphoma CD20. The goal is to detect a difference i...
What is the current status of trial NCT00137995?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 481 participants. The study started on 2003-06. Estimated completion is 2008-10.
What conditions does trial NCT00137995 study?
This clinical trial studies the following conditions: Lymphoma, Large-Cell, Diffuse.
What interventions are being tested in trial NCT00137995?
The interventions under investigation include: Rituximab (DRUG), Etoposide (DRUG), Carboplatine (DRUG), Ifosfamide + Mesna (DRUG), Cisplatine (DRUG).
Who is sponsoring clinical trial NCT00137995?
This trial is sponsored by Lymphoma Study Association, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00137995 being conducted?
This trial has 10 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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