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NCT00840931 · ClinicalTrials.gov registry record · Phase 1

Immunotherapy Using Lenalidomide + Bystander Vaccine in High Risk Myelodysplastic Syndrome (MDS)

A Phase 1 study of Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Completed
Registry status
Phase 1
Development phase
22
Enrollment target
1
Study location

NCT00840931: Completed Phase 1 study of Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

NCT00840931 is a Phase 1 study of Leukemia that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 22 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00840931, a Phase 1 study of Leukemia, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

COMPLETED
Registry status
Phase 1
Development phase
22 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to find out the maximum tolerated dose (MTD) of the combined therapy of lenalidomide (Revlimid®) and Granulocyte/macrophage colony stimulating factor and CD40 Ligand expressed in the K562 cell line (GM.CD40L) bystander vaccine. This research is also being done to see how well the combination of these drugs works to fight myelodysplastic syndrome (MDS).

Primary Outcome

Determination of MTD of GM.CD40L bystander vaccine with lenalidomide in high-risk MDS patients.

Conditions Studied

Interventions

  • DRUG lenalidomide
  • BIOLOGICAL bystander vaccine

Study Locations (1)

Florida

  • H. Lee Moffitt Cancer Center & Research Institute - Tampa

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2009-02-02
Est. Completion 2019-12
Phase Phase 1

What the finished NCT00840931 record still lists

NCT00840931 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (95% lower).

The record links to 1 condition, with Leukemia appearing as the primary indexed condition, and to 2 interventions - of which lenalidomide is the first listed.

NCT00840931 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT00840931 about?

NCT00840931 is a clinical study titled "Immunotherapy Using Lenalidomide + Bystander Vaccine in High Risk Myelodysplastic Syndrome (MDS)". The purpose of this study is to find out the maximum tolerated dose (MTD) of the combined therapy of lenalidomide (Revlimid®) and Granulocyte/macrophage colony stimulating factor and CD40 Ligand expressed in the K562 cell line (GM.CD40L) bystander vaccine. This research is also being done to see how...

What is the current status of trial NCT00840931?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2009-02-02. Estimated completion is 2019-12.

What conditions does trial NCT00840931 study?

This clinical trial studies the following conditions: Leukemia.

What interventions are being tested in trial NCT00840931?

The interventions under investigation include: lenalidomide (DRUG), bystander vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00840931?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00840931 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00840931's enrollment target sits among peer trials

22 179th of 233 higher than 53 of 233 other Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Leukemia 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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Source: ClinicalTrials.gov NCT00840931, the US trial registry maintained by the National Library of Medicine. NCT00840931 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.