An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Participants With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Blast Crisis

June 3, 2021 updated by: Novartis Pharmaceuticals

An Extension to a Phase II Open-label Study to Determine the Safety and Anti-leukemic Effects of STI571 in Patients With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Myeloid Blast Crisis

This extension II study allowed for further follow-up of the disease under treatment with imatinib mesylate and allow the participants to continue to receive imatinib mesylate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Poitiers, France
        • Novartis Investigative Site
  • Germany
      • Frankfurt/Main, Germany
        • Novartis Investigative Site
      • Leipzig, Germany
        • Novartis Investigative Site
      • Mannheim, Germany
        • Novartis Investigative Site
      • Muenchen, Germany
        • Novartis Investigative Site
  • Italy
      • Bologna, Italy
        • Novartis Investigative Site
      • Monza, Italy
        • Novartis Investigative Site
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Faber Institute
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1. Participants with Philadelphia chromosome positive chronic myelogenous leukemia (CML) in myeloid blast crisis (including both newly diagnosed and the participants who received prior therapy for accelerated or blastic phases), defined as either:

  1. ≥ 30% blast in peripheral blood and /or bone marrow
  2. by flow cytometry criteria

2. To be categorized as "newly diagnosed", participants with CML in blast crisis were not to have received specific therapy for CML accelerated or blast phases, with the exception of interferon-alpha or hydroxyurea.

3. serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT) not more than 3 times the upper limit of the normal range (ULN) (or not more than 5 times the ULN if clinically suspected leukemic involvement of the liver), serum creatinine concentration not more than 2 times the ULN, and total serum bilirubin level not more than 3 times the ULN at the laboratory where the analyses were performed.

4. A negative pregnancy test in participants of childbearing potential.

Exclusion Criteria:

  1. Participants with an eastern cooperative oncology group (ECOG) performance status score ≥ 3.
  2. Participants previously treated for blast crisis were not to have received any of the following with respect to Day 1 of the study: busulfan within six weeks, interferon-alpha within 48-hours, hydroxyurea within 24-hours, homoharringtonine within 14 days, low-dose, moderate dose or high dose cytosine arabinoside within 7, 14 and 28 days respectively, anthracyclines, mitoxantrone, or etoposide within 21 days.
  3. Participants receiving any hematopoietic stem cell transplantation within six weeks of Day 1.
  4. Participants receiving any other investigational agents within 28 days of Day 1.
  5. Participants with Grade 3/4 cardiac disease or any other serious concurrent medical conditions.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Imatinib Mesylate (STI571)
Participants initially received STI571 capsules or tablets, orally, initially once daily (400 mg) or (600 mg). The dosage was escalated from 400 mg to 600 mg and from 600 mg to 800 mg, on an individual basis as per the investigator's judgement. Treatment continued until death, or the development of intolerable toxicity, or the participant was considered not to benefit from treatment, whichever came first.
Drug: imatinib mesylate
Other Names:
  • Gleevec/Glivec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From first dose until death of the patient, up to 14 years.
Overall survival was defined as the number of events of death, expressed as a percentage, from the start of treatment to death, due to any reason.
From first dose until death of the patient, up to 14 years.
Overall Survival (by Month)
Time Frame: From first dose until death of the patient, up to 14 years.
Overall survival was defined as the time between start of treatment and death due to any reason. Overall survival for the participants was calculated by Kaplan-Meier estimates per month. The time was censored at the date of last contact for participants who discontinued treatment and were in survival follow-up.
From first dose until death of the patient, up to 14 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 1999

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 22, 2013

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

June 25, 2021

Last Update Submitted That Met QC Criteria

June 3, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSTI571A0102E2
  • 2005-001380-61 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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