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NCT01379209 · ClinicalTrials.gov registry record · Phase 1
Intravenous Administration of RGI-2001 in Patient Undergoing Allogenic Hematopoietic Stem Cell Transplantation (AHSCT)
A Phase 1 study, sponsored by Regimmune Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
NCT01379209: Completed Phase 1 study, sponsored by Regimmune Corporation.
NCT01379209 is a Phase 1 study that has completed, run by Regimmune Corporation. The registered enrollment target is 68 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01379209, a Phase 1 study, has completed, sponsored by Regimmune Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
Study Summary
The clinical trial is a Phase 1/2a, open-label, multi-center, dose-escalation study to evaluate the safety, tolerability and pharmacokinetic profile of RGI-2001 in patients undergoing AHSCT, with radiation or non-radiation myeloablative preparative treatment. The study will be separated into two parts; a dose escalation phase to assess safety, followed by a large expansion phase to further evaluate the pharmacologic effects of either a Maximum Tolerated Dose, Maximum Feasible Dose or optimal pharmacologically active dose of RGI-2001. The initial dose escalation safety portion of the study (Part 1) will include higher risk patients and limit the unrelated donor transplants. After safety is established in part 1 of the study, the second portion of the study will expand the enrollment criteria and allow transplantation by either related or unrelated donors. This study will endeavor to identify the dose range at which RGI-2001 has an acceptable safety profile, at which biologic activity is observed, and to guide possible dose levels to utilize in later phase studies based on biological activity.
Primary Outcome
The primary outcome measures are: * The incidence and severity of adverse events * The maximum tolerated dose (MTD) or maximum feasible dose (MFD) of RGI-2001, administered as a single intravenous infusion approximately 30 minutes after AHSCT
Interventions
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
- PROCEDURE Allogeneic Bone Marrow Transplantation
- DRUG RGI-2001
- DRUG Calcineurin Inhibitors
- DRUG Conditioning Regimen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2011-09 |
| Est. Completion | 2017-04 |
| Phase | Phase 1 |
What the finished NCT01379209 record still lists
NCT01379209 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 5 interventions - of which Allogeneic Hematopoietic Stem Cell Transplantation is the first listed.
NCT01379209 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01379209 about?
NCT01379209 is a clinical study titled "Intravenous Administration of RGI-2001 in Patient Undergoing Allogenic Hematopoietic Stem Cell Transplantation (AHSCT)". The clinical trial is a Phase 1/2a, open-label, multi-center, dose-escalation study to evaluate the safety, tolerability and pharmacokinetic profile of RGI-2001 in patients undergoing AHSCT, with radiation or non-radiation myeloablative preparative treatment. The study will be separated into two pa...
What is the current status of trial NCT01379209?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2011-09. Estimated completion is 2017-04.
What interventions are being tested in trial NCT01379209?
The interventions under investigation include: Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Allogeneic Bone Marrow Transplantation (PROCEDURE), RGI-2001 (DRUG), Calcineurin Inhibitors (DRUG), Conditioning Regimen (DRUG).
Who is sponsoring clinical trial NCT01379209?
This trial is sponsored by Regimmune Corporation, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01379209's enrollment target sits among peer trials
68 776th of 2000 higher than 1,219 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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