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NCT00060346 · ClinicalTrials.gov registry record · Phase 2
Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia
A Phase 2 study, sponsored by Eastern Cooperative Oncology Group.
- Terminated
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT00060346: Clinical Trial Phase 2 study, sponsored by Eastern Cooperative Oncology Group.
NCT00060346 is a Phase 2 study that was terminated before completion, run by Eastern Cooperative Oncology Group. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00060346, a Phase 2 study, was terminated before completion, sponsored by Eastern Cooperative Oncology Group.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with newly diagnosed Waldenstrom's macroglobulinemia.
Primary Outcome
Objective response assessed using standard myeloma response criteria. Objective response is defined as a \> 50% reduction in the quantitative IgM or M-Spike levels from baseline levels. Response must be documented by two measurements separated by at least 3 weeks.
Interventions
- DRUG Doxorubicin
- DRUG Vincristine
- DRUG Prednisone
- DRUG cyclophosphamide
- BIOLOGICAL rituximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2004-10-05 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
Why NCT00060346 stopped before completion
NCT00060346 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 5 interventions - of which Doxorubicin is the first listed.
NCT00060346 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00060346 about?
NCT00060346 is a clinical study titled "Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia". RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining rit...
What is the current status of trial NCT00060346?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2004-10-05. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00060346?
The interventions under investigation include: Doxorubicin (DRUG), Vincristine (DRUG), Prednisone (DRUG), cyclophosphamide (DRUG), rituximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00060346?
This trial is sponsored by Eastern Cooperative Oncology Group, which has 141 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00060346's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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