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NCT00577278 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of Allo-HCT for B-Cell NHL Using Zevalin, Fludarabine and Melphalan
A Phase 2 study, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT00577278: Completed Phase 2 study, sponsored by City of Hope Medical Center.
NCT00577278 is a Phase 2 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00577278, a Phase 2 study, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
Study Summary
RATIONALE: Giving monoclonal antibody therapy, radioimmunotherapy, and chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related donor that do not exactly match the patient's blood, are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and sirolimus before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects and how well giving indium In 111 ibritumomab tiuxetan and yttrium y 90 ibritumomab tiuxetan together with rituximab, fludarabine, melphalan, and donor stem cell transplant works in treating patients with B-cell non-Hodgkin lymphoma.
Primary Outcome
The primary endpoint was 2-year cumulative incidence of relapse/progression (RP), defined as time from alloHCT to disease recurrence or progression. Cumulative incidences for RP was generated in a competing-risk setting, given that death events were competing events.
Interventions
- BIOLOGICAL rituximab
- DRUG fludarabine phosphate
- DRUG tacrolimus
- DRUG melphalan
- DRUG sirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2007-10-03 |
| Est. Completion | 2023-12-14 |
| Phase | Phase 2 |
What the finished NCT00577278 record still lists
NCT00577278 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 5 interventions - of which rituximab is the first listed.
NCT00577278 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00577278 about?
NCT00577278 is a clinical study titled "A Phase II Study of Allo-HCT for B-Cell NHL Using Zevalin, Fludarabine and Melphalan". RATIONALE: Giving monoclonal antibody therapy, radioimmunotherapy, and chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related donor that do not exactly...
What is the current status of trial NCT00577278?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2007-10-03. Estimated completion is 2023-12-14.
What interventions are being tested in trial NCT00577278?
The interventions under investigation include: rituximab (BIOLOGICAL), fludarabine phosphate (DRUG), tacrolimus (DRUG), melphalan (DRUG), sirolimus (DRUG).
Who is sponsoring clinical trial NCT00577278?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00577278's enrollment target sits among peer trials
41 1352nd of 2000 higher than 639 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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