Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by NCIC Clinical Trials Group. The registered enrollment target is 849 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00078949
The ClinicalTrials.gov registry entry for NCT00078949 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 849 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NCIC Clinical Trials Group, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which cisplatin is the first listed.
NCT00078949 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.