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NCT01463852 · ClinicalTrials.gov registry record · Early Phase 1
A Study of the Effect of Vinca Alkaloids on c-Jun N-terminal Kinase (JNK) Phosphorylation in Patients With Chronic Lymphocytic Leukemia (CLL)
A Early Phase 1 study, sponsored by Dartmouth-Hitchcock Medical Center.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 11
- Enrollment target
NCT01463852 is a Early Phase 1 study that was terminated before completion, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 11 participants.
The verdict
NCT01463852, a Early Phase 1 study, was terminated before completion, sponsored by Dartmouth-Hitchcock Medical Center.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
In this proof-of-principle study, patients with chronic lymphocytic leukemia (CLL), who are scheduled to initiate treatment per the recommendations of their primary oncologist, will receive a single dose of vincristine 2 milligrams (mg). The objective is to determine if this single dose will induce rapid cell death in isolated CLL cells. Vincristine 2 mg will be administered to the participants intravenously over 5 minutes. Blood samples will be collected from an intravenous line inserted into the contralateral limb to that where the vincristine was given, at time zero (pre-vincristine treatment), immediately after vincristine administration (within 2-10 minutes upon completion of administration) and at 1, 2, 4 and 6 hours post-vincristine treatment. Patients will then at a later date receive chemotherapy treatment as prescribed by their primary oncologist. Within 7 days of vincristine administration, participants will receive a phone call from the research nurse to discuss potential toxicities. At the time of the initiation of standard chemotherapy treatment, the Principal Investigator will also meet with the participant to collect information regarding adverse events.
Interventions
- DRUG vincristine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2012-10 |
| Est. Completion | 2014-12 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01463852
The ClinicalTrials.gov registry entry for NCT01463852 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which vincristine is the first listed.
NCT01463852 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01463852 about?
NCT01463852 is a clinical study titled "A Study of the Effect of Vinca Alkaloids on c-Jun N-terminal Kinase (JNK) Phosphorylation in Patients With Chronic Lymphocytic Leukemia (CLL)". In this proof-of-principle study, patients with chronic lymphocytic leukemia (CLL), who are scheduled to initiate treatment per the recommendations of their primary oncologist, will receive a single dose of vincristine 2 milligrams (mg). The objective is to determine if this single dose will induce ...
What is the current status of trial NCT01463852?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 11 participants. The study started on 2012-10. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01463852?
The interventions under investigation include: vincristine (DRUG).
Who is sponsoring clinical trial NCT01463852?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
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