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NCT02483000 · ClinicalTrials.gov registry record · Phase 1
Anti-CD20 Radioimmunotherapy Before Chemotherapy and Stem Cell Transplant in Treating Patients With High-Risk B-Cell Malignancies
A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT02483000: Clinical Trial Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
NCT02483000 is a Phase 1 study that was terminated before completion, run by Fred Hutchinson Cancer Center. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02483000, a Phase 1 study, was terminated before completion, sponsored by Fred Hutchinson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dose of anti-cluster of differentiation (CD)20 radioimmunotherapy (RIT), and to see how well it works when given before chemotherapy and stem cell transplant in treating patients with B-cell malignancies that have not responded to treatment or have come back after responding to treatment. CD20 is a protein found on the cells of a type of cancer cell called B-cells. Anti-CD20 RIT attaches radioactive material to a drug that is designed to target CD20, which brings radioactive material to the cancer cells to kill the cells. This may kill more tumor cells while causing fewer side effects to healthy tissue. Adding anti-CD20 to standard chemotherapy and stem cell transplant may be more effective in treating patients with B-cell malignancies.
Primary Outcome
Following the completed observation of the final patient, a two-parameter logistic model will be fit to the data, thereby generating a dose-toxicity curve based on the observed DLT rate at the various dose levels visited. Based on this fitted model, the MTD is estimated to be the dose that is associated with a DLT rate of 25%.
Interventions
- DRUG Cytarabine
- DRUG Carmustine
- PROCEDURE Autologous Hematopoietic Stem Cell Transplantation
- BIOLOGICAL Anti-CD20 B9E9 scFv-Streptavidin Fusion Protein
- DRUG Clearing Agent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2017-02-01 |
| Est. Completion | 2020-09-02 |
| Phase | Phase 1 |
Why NCT02483000 stopped before completion
NCT02483000 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which Cytarabine is the first listed.
NCT02483000 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02483000 about?
NCT02483000 is a clinical study titled "Anti-CD20 Radioimmunotherapy Before Chemotherapy and Stem Cell Transplant in Treating Patients With High-Risk B-Cell Malignancies". This phase I/II trial studies the side effects and best dose of anti-cluster of differentiation (CD)20 radioimmunotherapy (RIT), and to see how well it works when given before chemotherapy and stem cell transplant in treating patients with B-cell malignancies that have not responded to treatment or ...
What is the current status of trial NCT02483000?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2017-02-01. Estimated completion is 2020-09-02.
What interventions are being tested in trial NCT02483000?
The interventions under investigation include: Cytarabine (DRUG), Carmustine (DRUG), Autologous Hematopoietic Stem Cell Transplantation (PROCEDURE), Anti-CD20 B9E9 scFv-Streptavidin Fusion Protein (BIOLOGICAL), Clearing Agent (DRUG).
Who is sponsoring clinical trial NCT02483000?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02483000's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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