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NCT00634244 · ClinicalTrials.gov registry record · Phase 2

Comparing Three Different Combination Chemotherapy Regimens in Treating Patients With Relapsed or Refractory 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
92
Enrollment target
20
Study locations

NCT00634244 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 92 participants, below the 116-participant average among 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT00634244, 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
92 participants
Enrollment target
20
Study locations

Study Summary

This randomized phase II trial is comparing three different combination chemotherapy regimens to see how well they work in treating patients with relapsed or refractory acute myeloid leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating patients with relapsed or refractory acute myeloid leukemia.

Interventions

  • DRUG carboplatin
  • DRUG sirolimus
  • DRUG cytarabine
  • DRUG alvocidib
  • DRUG mitoxantrone hydrochloride

Study Locations (20)

Pennsylvania

  • Geisinger Medical Center - Danville
  • Geisinger Medical Center-Cancer Center Hazleton - Hazleton
  • Penn State Milton S Hershey Medical Center - Hershey
  • Lewistown Hospital - Lewistown
  • Geisinger Medical Group - State College
  • Mount Nittany Medical Center - State College
  • Geisinger Wyoming Valley - Wilkes-Barre

Wisconsin

  • University of Wisconsin Hospital and Clinics - Madison
  • Froedtert and the Medical College of Wisconsin - Milwaukee

Alabama

  • University of Alabama at Birmingham - Birmingham

Arizona

  • Mayo Clinic in Arizona - Scottsdale

Florida

  • Mayo Clinic in Florida - Jacksonville

Illinois

  • Northwestern University - Chicago

Iowa

  • Siouxland Hematology Oncology Associates - Sioux City

Maryland

  • Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center - Baltimore

Trial Details

FieldValue
Enrollment Target 92 participants
Start Date 2008-10
Est. Completion 2014-10
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT00634244

The ClinicalTrials.gov registry entry for NCT00634244 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 29 other Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities trials with a reported enrollment target (21% lower). 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 5 interventions - of which carboplatin is the first listed.

NCT00634244 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Pennsylvania, Wisconsin, Alabama.

Frequently Asked Questions

What is clinical trial NCT00634244 about?

NCT00634244 is a clinical study titled "Comparing Three Different Combination Chemotherapy Regimens in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia". This randomized phase II trial is comparing three different combination chemotherapy regimens to see how well they work in treating patients with relapsed or refractory acute myeloid leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the...

What is the current status of trial NCT00634244?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2008-10. Estimated completion is 2014-10.

What conditions does trial NCT00634244 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 t(8;21)(q22;q22), Adult Acute Minimally Differentiated Myeloid Leukemia (M0).

What interventions are being tested in trial NCT00634244?

The interventions under investigation include: carboplatin (DRUG), sirolimus (DRUG), cytarabine (DRUG), alvocidib (DRUG), mitoxantrone hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00634244?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00634244 being conducted?

This trial has 20 study locations across Alabama, Arizona, Florida, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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