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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 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.

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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.

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

FieldValue
Enrollment Target 172 participants
Start Date 2011-04
Est. Completion 2014-05
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT01349972

The ClinicalTrials.gov registry entry for NCT01349972 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 172 participants, a figure that helps gauge the scale of data the investigators plan to collect, 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 listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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 reports 11 study locations spanning 10 distinct geographic areas - top geographies include 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.

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