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NCT00493181 · ClinicalTrials.gov registry record · Phase 2
Interleukin 11, Thrombocytopenia, Imatinib in Chronic Myelogenous Leukemia (CML) Patients
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT00493181: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00493181 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00493181, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find out if IL-11 (NeumegaTM) may increase the platelet count in patients with Chronic myeloid leukemia (CML) who develop low platelet counts while receiving therapy with imatinib mesylate (Gleevec, STI571), or other tyrosine kinase inhibitors such as AMN107, dasatinib, or SK1606. Primary Objective: 1\. To determine efficacy of low-dose interleukin-11, (IL-11, oprelvekin, NeumegaTM) in improving the thrombocytopenia associate with imatinib or other tyrosine kinase inhibitor therapy in patients with CML. Secondary Objective: 1\. To determine the safety of low-dose IL-11 in patients with CML and thrombocytopenia associated with imatinib or other tyrosine kinase inhibitors
Primary Outcome
Number of participants with platelet response of 'Complete Response' (CR) defined as a sustained (\>/= 3 months) platelet count \>/= 60 x 10\^9/L while continuing tyrosine kinase inhibitor (TKI) therapy or sustained (\>/= 3 months) re-escalation of TKI dose to the pre-thrombocytopenia level without recurrence of thrombocytopenia.
Interventions
- DRUG Interleukin-11 (IL-11 or Neumega)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2005-10 |
| Est. Completion | 2011-01 |
| Phase | Phase 2 |
What the finished NCT00493181 record still lists
NCT00493181 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Interleukin-11 (IL-11 or Neumega) is the first listed.
NCT00493181 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00493181 about?
NCT00493181 is a clinical study titled "Interleukin 11, Thrombocytopenia, Imatinib in Chronic Myelogenous Leukemia (CML) Patients". The goal of this clinical research study is to find out if IL-11 (NeumegaTM) may increase the platelet count in patients with Chronic myeloid leukemia (CML) who develop low platelet counts while receiving therapy with imatinib mesylate (Gleevec, STI571), or other tyrosine kinase inhibitors such as A...
What is the current status of trial NCT00493181?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2005-10. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00493181?
The interventions under investigation include: Interleukin-11 (IL-11 or Neumega) (DRUG).
Who is sponsoring clinical trial NCT00493181?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00493181's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 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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