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NCT01468311 · ClinicalTrials.gov registry record · Phase 1
Yttrium-90-labeled Daclizumab With Chemotherapy and Stem Cell Transplant for Hodgkin's Lymphoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01468311: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01468311 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01468311, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Background: * Hodgkins lymphoma (HL) is a highly treatable cancer. However, if HL does not respond to chemotherapy or returns after chemotherapy, further treatments often are not successful. * Some HL cells have a molecule called cluster of differentiation 25 (CD25) on the surface. Daclizumab is a drug that can detect CD25 on cells. In a treatment study for HL that did not respond to chemotherapy, daclizumab plus a radioactive atom called Yttrium 90 helped kill these HL cells. Researchers want to combine this 90Y daclizumab with high-dose chemotherapy and stem cell transplant. This treatment may be more effective than the daclizumab alone. Objectives: \- To see if yttrium-90 daclizumab, high-dose chemotherapy, and stem cell transplants can treat HL that has not responded to earlier treatments. Eligibility: \- Individuals at least 18 years of age who have Hodgkins lymphoma that has not responded to chemotherapy. Design: * Participants will be screened with a physical exam and medical history. They will also have blood and urine tests. * Participants will have filgrastim and plerixafor to move stem cells into the blood. Stem cells will be collected with apheresis. * Four weeks after stem cells are collected, participants will have the 90Y daclizumab and normal daclizumab to treat the HL. Chemotherapy will start 9 days after the first treatment. * Most participants will have a second dose of 90Y daclizumab 6 weeks after the first dose. * After each daclizumab treatment, participants will have several imaging studies of the chest and abdomen. Blood samples will also be collected. * On the day after the last day of chemotherapy, participants will receive the stem cells collected earlier. Filgrastim injections will help stimulate stem cell growth....
Primary Outcome
The MTD is defined as the dose level below the dose at which 2 out of 2 to 6 patients at a given dose level develop dose limiting toxicity (DLT). A DLT is defined as patients who develop either a Common Terminology Criteria in Adverse Events (CTCAE) v4.0 grade 3 or greater non-hematologic toxicity, with the exception of fatigue, of more than 5 days duration possibly, probably or definitely related to the infusion of 90Y-daclizumab prior to the start of BEAM chemotherapy (Day - 6) will have devel
Interventions
- DRUG BEAM
- PROCEDURE Auto stem cell transplant
- RADIATION 111In-daclizumab
- RADIATION 90Y-daclizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2011-10-11 |
| Est. Completion | 2020-10-22 |
| Phase | Phase 1 |
Why NCT01468311 stopped before completion
NCT01468311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 4 interventions - of which BEAM is the first listed.
NCT01468311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01468311 about?
NCT01468311 is a clinical study titled "Yttrium-90-labeled Daclizumab With Chemotherapy and Stem Cell Transplant for Hodgkin's Lymphoma". Background: * Hodgkins lymphoma (HL) is a highly treatable cancer. However, if HL does not respond to chemotherapy or returns after chemotherapy, further treatments often are not successful. * Some HL cells have a molecule called cluster of differentiation 25 (CD25) on the surface. Daclizumab is a ...
What is the current status of trial NCT01468311?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2011-10-11. Estimated completion is 2020-10-22.
What interventions are being tested in trial NCT01468311?
The interventions under investigation include: BEAM (DRUG), Auto stem cell transplant (PROCEDURE), 111In-daclizumab (RADIATION), 90Y-daclizumab (RADIATION).
Who is sponsoring clinical trial NCT01468311?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01468311's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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