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NCT00490529 · ClinicalTrials.gov registry record · Phase 2
Phase 1-2 of a CpG-Activated Whole Cell Vaccine Followed by Autologous Immunotransplant for MCL
A Phase 2 study, sponsored by Ronald Levy.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
NCT00490529: Completed Phase 2 study, sponsored by Ronald Levy.
NCT00490529 is a Phase 2 study that has completed, run by Ronald Levy. The registered enrollment target is 59 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00490529, a Phase 2 study, has completed, sponsored by Ronald Levy.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
Study Summary
Mantle cell lymphoma (MCL) is a sub-type of non-Hodgkin's lymphoma (NHL) which is generally considered incurable with current therapy. Participants will receive an autologous vaccine against their individual lymphoma after undergoing stem cell transplantation. This vaccination may prolong the time which patients will stay in remission from their disease.
Primary Outcome
Molecular residual disease (MRD) is defined as detection in blood samples by the ClonoSEQ test of the (11;14) (q13;q32) gene translocation. It is considered positive if a tumor-specific VDJ sequence is detected in the peripheral blood cells by Ig-HTS at a frequency of greater or equal to 1 molecule per 10,000 input leukocyte equivalents of DNA within 1 year post-autologous stem cell transplant (ASCT). The outcome will be reported as number and percent of participants that maintain MRD-negative s
Interventions
- DRUG Rituximab
- BIOLOGICAL CpG-MCL vaccine
- BIOLOGICAL PF-3512676
- PROCEDURE Vaccine-primed T-cells
- PROCEDURE Autologous hematopoietic stem cell transplant (HSCT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2009-08 |
| Est. Completion | 2017-12-14 |
| Phase | Phase 2 |
What the finished NCT00490529 record still lists
NCT00490529 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 5 interventions - of which Rituximab is the first listed.
NCT00490529 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00490529 about?
NCT00490529 is a clinical study titled "Phase 1-2 of a CpG-Activated Whole Cell Vaccine Followed by Autologous Immunotransplant for MCL". Mantle cell lymphoma (MCL) is a sub-type of non-Hodgkin's lymphoma (NHL) which is generally considered incurable with current therapy. Participants will receive an autologous vaccine against their individual lymphoma after undergoing stem cell transplantation. This vaccination may prolong the time w...
What is the current status of trial NCT00490529?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2009-08. Estimated completion is 2017-12-14.
What interventions are being tested in trial NCT00490529?
The interventions under investigation include: Rituximab (DRUG), CpG-MCL vaccine (BIOLOGICAL), PF-3512676 (BIOLOGICAL), Vaccine-primed T-cells (PROCEDURE), Autologous hematopoietic stem cell transplant (HSCT) (PROCEDURE).
Who is sponsoring clinical trial NCT00490529?
This trial is sponsored by Ronald Levy, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00490529's enrollment target sits among peer trials
59 1133rd of 2000 higher than 866 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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