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NCT00733824 · ClinicalTrials.gov registry record · Phase 1
Intravenous AMD3100 for Collection of Autologous Peripheral Blood Stem Cells in Patients With Lymphoma
A Phase 1 study of Lymphoma, Non-Hodgkin and Hodgkin Disease, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
- 1
- Study location
NCT00733824: Completed Phase 1 study of Lymphoma, Non-Hodgkin and Hodgkin Disease, sponsored by Washington University School of Medicine.
NCT00733824 is a Phase 1 study of Lymphoma, Non-Hodgkin and Hodgkin Disease that has completed, run by Washington University School of Medicine. The registered enrollment target is 61 participants, below the 388-participant average among 58 other Lymphoma, Non-Hodgkin trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00733824, a Phase 1 study of Lymphoma, Non-Hodgkin and Hodgkin Disease, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the safety and efficacy of intravenous AMD3100 added to a standard G-CSF mobilization regimen of patients undergoing autologous stem cell transplantation for lymphoma. The investigators hypothesize that after stem cell mobilization with G-CSF plus IV AMD3100, a significantly higher proportion of lymphoma patients will collect ≥ 2 x 10E6 CD34+ cells/kg.
Primary Outcome
* MTD: the highest dose level of AMD3100 at which ≤ 1 of 6 participants experience a dose limiting toxicity (DLT). The MTD will be the Phase II dose. * DLT: selected grade III or higher (hematologic, cardiac, pulmonary, hepatobiliary/pancreatic, renal, or CNS) not attributable to any other cause.
Conditions Studied
Interventions
- DRUG G-CSF
- PROCEDURE Apheresis
- DRUG AMD3100
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2008-11 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
What the finished NCT00733824 record still lists
NCT00733824 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 388-participant average among 58 other Lymphoma, Non-Hodgkin trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Lymphoma, Non-Hodgkin appearing as the primary indexed condition, and to 3 interventions - of which G-CSF is the first listed.
NCT00733824 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT00733824 about?
NCT00733824 is a clinical study titled "Intravenous AMD3100 for Collection of Autologous Peripheral Blood Stem Cells in Patients With Lymphoma". This study will evaluate the safety and efficacy of intravenous AMD3100 added to a standard G-CSF mobilization regimen of patients undergoing autologous stem cell transplantation for lymphoma. The investigators hypothesize that after stem cell mobilization with G-CSF plus IV AMD3100, a significantl...
What is the current status of trial NCT00733824?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2008-11. Estimated completion is 2013-09.
What conditions does trial NCT00733824 study?
This clinical trial studies the following conditions: Lymphoma, Non-Hodgkin, Hodgkin Disease.
What interventions are being tested in trial NCT00733824?
The interventions under investigation include: G-CSF (DRUG), Apheresis (PROCEDURE), AMD3100 (DRUG).
Who is sponsoring clinical trial NCT00733824?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00733824 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00733824's enrollment target sits among peer trials
61 31st of 58 higher than 28 of 58 other Lymphoma, Non-Hodgkin trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma, Non-Hodgkin 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.
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