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NCT00078949 · ClinicalTrials.gov registry record · Phase 3
Chemotherapy Before Autologous Stem Cell Transplantation +/- Rituximab in Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
A Phase 3 study, sponsored by NCIC Clinical Trials Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 849
- Enrollment target
NCT00078949: Completed Phase 3 study, sponsored by NCIC Clinical Trials Group.
NCT00078949 is a Phase 3 study that has completed, run by NCIC Clinical Trials Group. The registered enrollment target is 849 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00078949, a Phase 3 study, has completed, sponsored by NCIC Clinical Trials Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 849 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as dexamethasone, cisplatin, gemcitabine, and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving rituximab as maintenance therapy after stem cell transplantation may kill any remaining cancer cells. It is not yet known which salvage chemotherapy regimen is more effective before autologous stem cell transplantation in treating relapsed or refractory non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying salvage chemotherapy using dexamethasone, cisplatin, and gemcitabine to see how well it works compared to dexamethasone, cisplatin, and cytarabine given before autologous stem cell transplantation in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. This trial also is studying giving rituximab as maintenance therapy to see how well it works compared to no further therapy after stem cell transplantation. Rituximab was added to both salvage treatment arms for CD20+ patients in a protocol amendment in 2005.
Primary Outcome
The overall response rate by arm is calculated as total number of responders (CR + CRu + PR) / (all patients in the ITT analysis population).
Interventions
- DRUG cisplatin
- BIOLOGICAL rituximab
- DRUG dexamethasone
- DRUG cytarabine
- DRUG gemcitabine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 849 participants |
| Start Date | 2003-08-27 |
| Est. Completion | 2018-12 |
| Phase | Phase 3 |
What the finished NCT00078949 record still lists
NCT00078949 is an interventional study that assigns participants to a tested intervention. The registered 849 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 5 interventions - of which cisplatin is the first listed.
NCT00078949 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00078949 about?
NCT00078949 is a clinical study titled "Chemotherapy Before Autologous Stem Cell Transplantation +/- Rituximab in Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma". RATIONALE: Drugs used in chemotherapy, such as dexamethasone, cisplatin, gemcitabine, and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of c...
What is the current status of trial NCT00078949?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 849 participants. The study started on 2003-08-27. Estimated completion is 2018-12.
What interventions are being tested in trial NCT00078949?
The interventions under investigation include: cisplatin (DRUG), rituximab (BIOLOGICAL), dexamethasone (DRUG), cytarabine (DRUG), gemcitabine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00078949?
This trial is sponsored by NCIC Clinical Trials Group, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00078949's enrollment target sits among peer trials
849 389th of 2000 higher than 1,612 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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