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NCT03007147 · ClinicalTrials.gov registry record · Phase 3

Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

A Phase 3 study of Acute Lymphoblastic Leukemia and Mixed Phenotype Acute Leukemia, sponsored by Children's Oncology Group.

Active
Registry status
Phase 3
Development phase
475
Enrollment target
20
Study locations

NCT03007147 is a Phase 3 study of Acute Lymphoblastic Leukemia and Mixed Phenotype Acute Leukemia that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 475 participants, above the 378-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (26% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT03007147, a Phase 3 study of Acute Lymphoblastic Leukemia and Mixed Phenotype Acute Leukemia, is active but no longer recruiting, sponsored by Children's Oncology Group.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
475 participants
Enrollment target
20
Study locations

Study Summary

This randomized phase III trial studies how well imatinib mesylate works in combination with two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to improve outcomes in children and adolescents with Philadelphia chromosome positive (Ph+) ALL when given with strong chemotherapy, but the combination has many side effects. This trial is testing whether a different chemotherapy regimen may work as well as the stronger one but have fewer side effects when given with imatinib. The trial is also testing how well the combination of chemotherapy and imatinib works in another group of patients with a type of ALL that is similar to Ph+ ALL. This type of ALL is called "ABL-class fusion positive ALL", and because it is similar to Ph+ ALL, is thought it will respond well to the combination of agents used to treat Ph+ ALL.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Cytarabine
  • DRUG Calaspargase Pegol
  • DRUG Daunorubicin Hydrochloride
  • PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation

Study Locations (20)

California

  • Kaiser Permanente Downey Medical Center - Downey
  • City of Hope Comprehensive Cancer Center - Duarte
  • Loma Linda University Medical Center - Loma Linda
  • Miller Children's and Women's Hospital Long Beach - Long Beach
  • Children's Hospital Los Angeles - Los Angeles
  • Cedars Sinai Medical Center - Los Angeles
  • Valley Children's Hospital - Madera
  • UCSF Benioff Children's Hospital Oakland - Oakland
  • Kaiser Permanente-Oakland - Oakland
  • Children's Hospital of Orange County - Orange
  • Lucile Packard Children's Hospital Stanford University - Palo Alto
  • University of California Davis Comprehensive Cancer Center - Sacramento
  • Rady Children's Hospital - San Diego - San Diego

Arizona

  • Banner Children's at Desert - Mesa
  • Phoenix Childrens Hospital - Phoenix
  • Banner University Medical Center - Tucson - Tucson

Alabama

  • Children's Hospital of Alabama - Birmingham
  • USA Health Strada Patient Care Center - Mobile

Alaska

  • Providence Alaska Medical Center - Anchorage

Arkansas

  • Arkansas Children's Hospital - Little Rock

Trial Details

FieldValue
Enrollment Target 475 participants
Start Date 2017-08-08
Est. Completion 2027-09-30
Phase Phase 3

Sponsor

Children's Oncology Group

342 total trials

What the Registry Record Tells You About NCT03007147

The ClinicalTrials.gov registry entry for NCT03007147 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 475 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 378-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (26% higher). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT03007147 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arizona, Alabama.

Frequently Asked Questions

What is clinical trial NCT03007147 about?

NCT03007147 is a clinical study titled "Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia". This randomized phase III trial studies how well imatinib mesylate works in combination with two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to improve outcomes in chil...

What is the current status of trial NCT03007147?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 475 participants. The study started on 2017-08-08. Estimated completion is 2027-09-30.

What conditions does trial NCT03007147 study?

This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia, B Acute Lymphoblastic Leukemia, T Acute Lymphoblastic Leukemia.

What interventions are being tested in trial NCT03007147?

The interventions under investigation include: Cyclophosphamide (DRUG), Cytarabine (DRUG), Calaspargase Pegol (DRUG), Daunorubicin Hydrochloride (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE).

Who is sponsoring clinical trial NCT03007147?

This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03007147 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.