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NCT01490723 · ClinicalTrials.gov registry record · Phase 2
Zevalin-Containing Nonmyeloablative Conditioning for Stem Cell Transplantation (SCT)
A Phase 2 study of Lymphoma and Leukemia, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT01490723: Completed Phase 2 study of Lymphoma and Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT01490723 is a Phase 2 study of Lymphoma and Leukemia that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 20 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01490723, a Phase 2 study of Lymphoma and Leukemia, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research study is to learn if adding Zevalin (ibritumomab tiuxetan) to low-intensity chemotherapy (the combination of rituximab, bendamustine, and fludarabine), followed by an allogeneic stem cell transplant, can help to control lymphoma. The safety of this combination will also be studied. Two (2) forms of ibritumomab tiuxetan will be used in this study. 90Y-ibritumomab tiuxetan is designed to attach to lymphoma cells and destroy the cells using a radioactive particle that is attached to it. 111In-ibritumomab tiuxetan is like 90Y- ibritumomab tiuxetan, but the radioactive particle that is attached to it does not kill lymphoma cells. The radioactive particle makes the drug able to be seen inside your body. It is being used in this study to predict how fast the study drug will travel in the body and how long the drug stays in the body. Rituximab is designed to attach to lymphoma cells, which may cause them to die. Bendamustine is designed to damage and destroy the DNA (genetic material) of cancer cells. Fludarabine is designed to make cancer cells less able to repair damaged DNA. This may increase the likelihood of the cells dying.
Primary Outcome
Number of participants without treatment related mortality at day 100.
Interventions
- DRUG Fludarabine
- DRUG Rituximab
- DRUG 111In Ibritumomab
- PROCEDURE Planar Scintigraphy Imaging
- DRUG 90Y IbritumomabTiuxetan
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-01 |
| Est. Completion | 2019-04-24 |
| Phase | Phase 2 |
What the finished NCT01490723 record still lists
NCT01490723 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Fludarabine is the first listed.
NCT01490723 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01490723 about?
NCT01490723 is a clinical study titled "Zevalin-Containing Nonmyeloablative Conditioning for Stem Cell Transplantation (SCT)". The goal of this clinical research study is to learn if adding Zevalin (ibritumomab tiuxetan) to low-intensity chemotherapy (the combination of rituximab, bendamustine, and fludarabine), followed by an allogeneic stem cell transplant, can help to control lymphoma. The safety of this combination will...
What is the current status of trial NCT01490723?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2013-01. Estimated completion is 2019-04-24.
What conditions does trial NCT01490723 study?
This clinical trial studies the following conditions: Lymphoma, Leukemia.
What interventions are being tested in trial NCT01490723?
The interventions under investigation include: Fludarabine (DRUG), Rituximab (DRUG), 111In Ibritumomab (DRUG), Planar Scintigraphy Imaging (PROCEDURE), 90Y IbritumomabTiuxetan (DRUG).
Who is sponsoring clinical trial NCT01490723?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01490723 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01490723's enrollment target sits among peer trials
20 246th of 299 higher than 49 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma 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.
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