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NCT01434472 · ClinicalTrials.gov registry record · Phase 2
High-Dose Y-90-Ibritumomab Tiuxetan Added to Reduced-Intensity Allogeneic Stem Cell Transplant Regimen for Relapsed or Refractory Aggressive B-Cell Lymphoma
A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01434472 is a Phase 2 study that was terminated before completion, run by Fred Hutchinson Cancer Center. The registered enrollment target is 20 participants.
The verdict
NCT01434472, a Phase 2 study, was terminated before completion, sponsored by Fred Hutchinson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This phase II trial studies the side effects and how well high-dose yttrium-90 (Y-90)-ibritumomab tiuxetan (anti-cluster of differentiation \[CD\]20) followed by fludarabine phosphate, low-dose total body irradiation (TBI), and donor peripheral blood stem cell transplant (PBSCT) work in treating patients with aggressive B-cell lymphoma that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory). Radiolabeled monoclonal antibodies, such as Y-90-ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them with less effect on normal cells. Giving chemotherapy, such as fludarabine phosphate, and TBI before a donor PBSCT helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. However, high-dose radiolabeled antibodies also destroy healthy blood cells in the patient's body. When healthy stem cells from a donor are infused into the patient (stem cell transplant), they may help the patient's body replace these blood cells. Giving high-dose Y-90-ibritumomab tiuxetan followed by fludarabine phosphate, TBI, and donor PBSCT may be an effective treatment for patients with B-cell lymphoma.
Interventions
- DRUG Mycophenolate Mofetil
- DRUG Fludarabine Phosphate
- DRUG Cyclosporine
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
- RADIATION Indium In-111 Ibritumomab Tiuxetan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-11-16 |
| Est. Completion | 2020-05-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01434472
The ClinicalTrials.gov registry entry for NCT01434472 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Mycophenolate Mofetil is the first listed.
NCT01434472 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01434472 about?
NCT01434472 is a clinical study titled "High-Dose Y-90-Ibritumomab Tiuxetan Added to Reduced-Intensity Allogeneic Stem Cell Transplant Regimen for Relapsed or Refractory Aggressive B-Cell Lymphoma". This phase II trial studies the side effects and how well high-dose yttrium-90 (Y-90)-ibritumomab tiuxetan (anti-cluster of differentiation \[CD\]20) followed by fludarabine phosphate, low-dose total body irradiation (TBI), and donor peripheral blood stem cell transplant (PBSCT) work in treating pat...
What is the current status of trial NCT01434472?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2011-11-16. Estimated completion is 2020-05-06.
What interventions are being tested in trial NCT01434472?
The interventions under investigation include: Mycophenolate Mofetil (DRUG), Fludarabine Phosphate (DRUG), Cyclosporine (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Indium In-111 Ibritumomab Tiuxetan (RADIATION).
Who is sponsoring clinical trial NCT01434472?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
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