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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: Clinical Trial Phase 1 study, sponsored by Barbara Ann Karmanos Cancer Institute.
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, 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
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.
Primary Outcome
After drug infusion, participants will be closely monitored for at least 4 hours for side effects
Interventions
- DRUG Denileukin Diftitox (Ontak)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2010-11 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
Why NCT01251952 stopped before completion
NCT01251952 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 1 intervention - of which Denileukin Diftitox (Ontak) is the first listed.
NCT01251952 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01251952'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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