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NCT01349972 · ClinicalTrials.gov registry record · Phase 2
Alvocidib, Cytarabine, and Mitoxantrone Hydrochloride or Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed 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
- 172
- Enrollment target
- 11
- Study locations
NCT01349972: 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).
NCT01349972 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 172 participants, above the 113-participant average among 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials with a reported enrollment target (52% higher). The trial reports 11 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01349972, 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
- 172 participants
- Enrollment target
- 11
- Study locations
Study Summary
This randomized phase II trial is studying how alvocidib, cytarabine, and mitoxantrone hydrochloride work compared to cytarabine and daunorubicin hydrochloride in treating patients with newly diagnosed acute myeloid leukemia. Alvocidib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine, mitoxantrone hydrochloride, and daunorubicin hydrochloride work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving alvocidib, cytarabine, and mitoxantrone hydrochloride is more effective than giving cytarabine and daunorubicin hydrochloride in treating patients with acute myeloid leukemia.
Primary Outcome
Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/cu mm and a platelet count of 100,000/cu mm, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. These criteria are taken from Dohner H, Estey EH, Amadori S, et al. Diagnosis and management of acute myeloid leukemia in a
Conditions Studied
Interventions
- DRUG cytarabine
- DRUG alvocidib
- DRUG daunorubicin hydrochloride
- DRUG mitoxantrone hydrochloride
Study Locations (11)
Maryland
- University of Maryland/Greenebaum Cancer Center - Baltimore
- Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center - Baltimore
Arizona
- Mayo Clinic Scottsdale-Phoenix - Scottsdale
Florida
- Moffitt Cancer Center - Tampa
Georgia
- Blood and Marrow Transplant Group of Georgia - Atlanta
Illinois
- University of Chicago - Chicago
Minnesota
- Mayo Clinic - Rochester
North Carolina
- University of North Carolina - Chapel Hill
Tennessee
- Vanderbilt-Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2011-04 |
| Est. Completion | 2014-05 |
| Phase | Phase 2 |
What the finished NCT01349972 record still lists
NCT01349972 is an interventional study that assigns participants to a tested intervention. The registered 172 participants enrollment target is mid-sized for trials with a published cap, above the 113-participant average among 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials with a reported enrollment target (52% higher).
The record links to 10 conditions, with Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities appearing as the primary indexed condition, and to 4 interventions - of which cytarabine is the first listed.
NCT01349972 lists 11 locations in 10 states (Maryland, Arizona, Florida).
Frequently Asked Questions
What is clinical trial NCT01349972 about?
NCT01349972 is a clinical study titled "Alvocidib, Cytarabine, and Mitoxantrone Hydrochloride or Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia". This randomized phase II trial is studying how alvocidib, cytarabine, and mitoxantrone hydrochloride work compared to cytarabine and daunorubicin hydrochloride in treating patients with newly diagnosed acute myeloid leukemia. Alvocidib may stop the growth of cancer cells by blocking some of the enzy...
What is the current status of trial NCT01349972?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 172 participants. The study started on 2011-04. Estimated completion is 2014-05.
What conditions does trial NCT01349972 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 Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Minimally Differentiated Myeloid Leukemia (M0).
What interventions are being tested in trial NCT01349972?
The interventions under investigation include: cytarabine (DRUG), alvocidib (DRUG), daunorubicin hydrochloride (DRUG), mitoxantrone hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01349972?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01349972 being conducted?
This trial has 11 study locations across Arizona, Florida, Georgia, Illinois, Maryland. 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
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Where NCT01349972's enrollment target sits among peer trials
172 3rd of 29 higher than 27 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.
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