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NCT00352365 · ClinicalTrials.gov registry record · Phase 2
Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia
A Phase 2 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
- 20
- Study locations
NCT00352365: Completed Phase 2 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), sponsored by National Cancer Institute (NCI).
NCT00352365 is a Phase 2 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 41 participants, below the 117-participant average among 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00352365, a Phase 2 study of Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial is studying how well lenalidomide works in treating older patients with acute myeloid leukemia with abnormal chromosome 5q. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.
Primary Outcome
Morphologic complete remission (CR): ANC \>=1,000/mcl, platelet count \>=100,000/mcl, \<5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be \<1,000/mcl and/or platelet count \<100,000/mcl.
Conditions Studied
Interventions
- DRUG lenalidomide
Study Locations (20)
Montana
- Montana Cancer Consortium CCOP - Billings
- Northern Rockies Radiation Oncology Center - Billings
- Saint Vincent Healthcare - Billings
- Hematology-Oncology Centers of the Northern Rockies PC - Billings
- Billings Clinic - Billings
- Deaconess Medical Center - Billings
- Bozeman Deaconess Cancer Center - Bozeman
- Bozeman Deaconess Hospital - Bozeman
- Saint James Community Hospital and Cancer Treatment Center - Butte
- Berdeaux, Donald MD (UIA Investigator) - Great Falls
California
- Shasta Regional Medical Center - Redding
- Sutter Roseville Medical Center - Roseville
- Sutter General Hospital - Sacramento
Illinois
- Cancer Care Center of Decatur - Decatur
- Decatur Memorial Hospital - Decatur
- Memorial Medical Center - Springfield
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Kansas
- Salina Regional Health Center - Salina
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2006-06 |
| Est. Completion | 2011-07-01 |
| Phase | Phase 2 |
What the finished NCT00352365 record still lists
NCT00352365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 117-participant average among 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials with a reported enrollment target (65% lower).
The record links to 10 conditions, with Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities appearing as the primary indexed condition, and to 1 intervention - of which lenalidomide is the first listed.
NCT00352365 names 20 study sites across 7 states, led by Montana, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT00352365 about?
NCT00352365 is a clinical study titled "Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia". This phase II trial is studying how well lenalidomide works in treating older patients with acute myeloid leukemia with abnormal chromosome 5q. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.
What is the current status of trial NCT00352365?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2006-06. Estimated completion is 2011-07-01.
What conditions does trial NCT00352365 study?
This clinical trial studies the following conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2).
What interventions are being tested in trial NCT00352365?
The interventions under investigation include: lenalidomide (DRUG).
Who is sponsoring clinical trial NCT00352365?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00352365 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
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 NCT00352365's enrollment target sits among peer trials
41 16th of 29 higher than 14 of 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities 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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