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NCT01251952 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation
A Phase 1 study, sponsored by Barbara Ann Karmanos Cancer Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT01251952 is a Phase 1 study that was terminated before completion, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 2 participants.
The verdict
NCT01251952, a Phase 1 study, was terminated before completion, sponsored by Barbara Ann Karmanos Cancer Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
The primary goal of this study is to determine the feasibility and safety of giving two doses of denileukin diftitox (DD) at days 0 and 21 post autologous stem cell transplantation in a dose escalation fashion. Secondary goals include evaluating the the effect of DD on the number and percentage of T-regs in the peripheral blood post transplant at each dose level, the effect of DD on T cell (CD4/CD8) reconstitution post transplant at each dose level and determining the time to engraftment: absolute neutrophil count (\>0.5 x 10\^9/L for 3 consecutive days), and platelet (\>20X 10\^9/L for 3 consecutive days). The hypothesis for the study is based on the ability of DD to deplete T-regs and subsequently enhance the immune reconstitution and reverse post transplant lymphopenia. This may indirectly enhance the efficacy of autologous transplantation and reduce disease relapse.
Interventions
- DRUG Denileukin Diftitox (Ontak)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2010-11 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01251952
The ClinicalTrials.gov registry entry for NCT01251952 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Barbara Ann Karmanos Cancer Institute, which has 139 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Denileukin Diftitox (Ontak) is the first listed.
NCT01251952 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01251952 about?
NCT01251952 is a clinical study titled "Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation". The primary goal of this study is to determine the feasibility and safety of giving two doses of denileukin diftitox (DD) at days 0 and 21 post autologous stem cell transplantation in a dose escalation fashion. Secondary goals include evaluating the the effect of DD on the number and percentage of T...
What is the current status of trial NCT01251952?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2010-11. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01251952?
The interventions under investigation include: Denileukin Diftitox (Ontak) (DRUG).
Who is sponsoring clinical trial NCT01251952?
This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 139 total clinical trials registered on ClinicalTrials.gov.
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