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NCT01267643 · ClinicalTrials.gov registry record · Phase 1
Alefacept in Patients With Relapsed/Refractory Aplastic Anemia
A Phase 1 study, sponsored by The Cleveland Clinic.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT01267643: Clinical Trial Phase 1 study, sponsored by The Cleveland Clinic.
NCT01267643 is a Phase 1 study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01267643, a Phase 1 study, was terminated before completion, sponsored by The Cleveland Clinic.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
Aplastic Anemia (AA) is an autoimmune hematologic stem cell disease mediated by activated T-lymphocytes that leads to pancytopenia. The disease related morbidity and mortality if left untreated can approach 90%. For over 30 years, anti-thymocyte globulin (ATG) in combination with cyclosporine (CsA) remains the standard therapy. However, the treatment response with ATG is at best between 50-60% with a sizeable number of partial responses. Treatment with ATG is also associated with significant toxicity and high relapse rate that can be as high as 45%. Since the prognosis in refractory and relapsed AA remains poor, there is a need for less toxic novel immunosuppressive agents that can improve response rates and remission duration in refractory and relapsed AA. Alefacept is a human recombinant dimeric fusion protein composed of the terminal portion of leukocyte functioning antigen-3 (LFA3/CD58) and the Fc portion of human IgG1. It prevents co-stimulatory signals between antigen presenting cells and memory T cells by competitive inhibition of CD2 in T cells, induces selective apoptosis of CD4+ and CD8+ memory effector T cells by interaction between the Fc portion of IgG1 and the FcyIII in NK cells, and possibly direct ligation of CD2 molecules on T cells that subsequently result in the alteration in T cell agonist signaling. It has been used successfully in the treatment of other T cell mediated disorders particularly psoriasis and steroid refractory graft versus host disease (GVHD) with minimal side effects. In a case of liver transplant associated AA (similar to transfusion associated AA) which is fatal in most patients, Alefacept induced remission after patient did not respond to ATG and other immunosuppressants. The investigators hypothesize that the LFA3-CD2 co-stimulatory pathway play an important role in the immune pathogenesis of AA and treatment with Alefacept can help treat refractory/relapsed cases of AA.
Primary Outcome
The dosing cohorts includes (Cohort -1= 5 mg IV weekly, Cohort 1= 7.5 mg IV weekly, Cohort 2= 10 mg IV weekly, and Cohort 3= 12.5 mg IV weekly). The MTD will be defined as the dose level that has maxiumum effectiveness with minimal toxicity.
Interventions
- DRUG Alefacept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2011-05 |
| Est. Completion | 2013-04-16 |
| Phase | Phase 1 |
Why NCT01267643 stopped before completion
NCT01267643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Alefacept is the first listed.
NCT01267643 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01267643 about?
NCT01267643 is a clinical study titled "Alefacept in Patients With Relapsed/Refractory Aplastic Anemia". Aplastic Anemia (AA) is an autoimmune hematologic stem cell disease mediated by activated T-lymphocytes that leads to pancytopenia. The disease related morbidity and mortality if left untreated can approach 90%. For over 30 years, anti-thymocyte globulin (ATG) in combination with cyclosporine (CsA) ...
What is the current status of trial NCT01267643?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2011-05. Estimated completion is 2013-04-16.
What interventions are being tested in trial NCT01267643?
The interventions under investigation include: Alefacept (DRUG).
Who is sponsoring clinical trial NCT01267643?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01267643's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 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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