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NCT01678443 · ClinicalTrials.gov registry record · Phase 1
Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies
A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT01678443: Clinical Trial Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
NCT01678443 is a Phase 1 study that was terminated before completion, run by Fred Hutchinson Cancer Center. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01678443, a Phase 1 study, was terminated before completion, sponsored by Fred Hutchinson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of monoclonal antibody therapy before stem cell transplant in treating patients with relapsed or refractory lymphoid malignancies. Radiolabeled monoclonal antibodies, such as yttrium-90 anti-CD45 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving radiolabeled monoclonal antibody before a stem cell transplant may be an effective treatment for relapsed or refractory lymphoid malignancies.
Primary Outcome
A DLT (dose limiting toxicity) is defined as a therapy-related grade III or IV Bearman (transplant) toxicity within 30 days of transplant.
Interventions
- PROCEDURE peripheral blood stem cell transplantation
- BIOLOGICAL indium In 111 anti-CD45 monoclonal antibody BC8
- RADIATION yttrium Y 90 anti-CD45 monoclonal antibody BC8
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 1999-09-01 |
| Est. Completion | 2018-09-27 |
| Phase | Phase 1 |
Why NCT01678443 stopped before completion
NCT01678443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which peripheral blood stem cell transplantation is the first listed.
NCT01678443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01678443 about?
NCT01678443 is a clinical study titled "Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies". This phase I trial studies the side effects and best dose of monoclonal antibody therapy before stem cell transplant in treating patients with relapsed or refractory lymphoid malignancies. Radiolabeled monoclonal antibodies, such as yttrium-90 anti-CD45 monoclonal antibody BC8, can find cancer cells...
What is the current status of trial NCT01678443?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 1999-09-01. Estimated completion is 2018-09-27.
What interventions are being tested in trial NCT01678443?
The interventions under investigation include: peripheral blood stem cell transplantation (PROCEDURE), indium In 111 anti-CD45 monoclonal antibody BC8 (BIOLOGICAL), yttrium Y 90 anti-CD45 monoclonal antibody BC8 (RADIATION).
Who is sponsoring clinical trial NCT01678443?
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 NCT01678443's enrollment target sits among peer trials
2 2000th of 2000 the lowest 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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