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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

Primary Purpose

Philadelphia Chromosome Positive CML

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
imatinib mesylate
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Philadelphia Chromosome Positive CML focused on measuring Chronic Myelogenous Leukemia, CML, Philadelphia Chromosome, Blast crisis, Imatinib mesylate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: ≥ 30% blast in peripheral blood and /or bone marrow 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: Participants with an eastern cooperative oncology group (ECOG) performance status score ≥ 3. 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. Participants receiving any hematopoietic stem cell transplantation within six weeks of Day 1. Participants receiving any other investigational agents within 28 days of Day 1. Participants with Grade 3/4 cardiac disease or any other serious concurrent medical conditions. Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • University of Chicago
  • Dana Faber Institute
  • MD Anderson Cancer Center
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imatinib Mesylate (STI571)

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall Survival
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.
Overall Survival (by Month)
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.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
June 3, 2021
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00171158
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 26, 1999 (Actual)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 22, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Philadelphia Chromosome Positive CML
Keywords
Chronic Myelogenous Leukemia, CML, Philadelphia Chromosome, Blast crisis, Imatinib mesylate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imatinib Mesylate (STI571)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Other Intervention Name(s)
Gleevec/Glivec
Primary Outcome Measure Information:
Title
Overall Survival
Description
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.
Time Frame
From first dose until death of the patient, up to 14 years.
Title
Overall Survival (by Month)
Description
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.
Time Frame
From first dose until death of the patient, up to 14 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: ≥ 30% blast in peripheral blood and /or bone marrow 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: Participants with an eastern cooperative oncology group (ECOG) performance status score ≥ 3. 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. Participants receiving any hematopoietic stem cell transplantation within six weeks of Day 1. Participants receiving any other investigational agents within 28 days of Day 1. Participants with Grade 3/4 cardiac disease or any other serious concurrent medical conditions. Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Dana Faber Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Novartis Investigative Site
City
Poitiers
Country
France
Facility Name
Novartis Investigative Site
City
Frankfurt/Main
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
Country
Germany
Facility Name
Novartis Investigative Site
City
Mannheim
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
Country
Germany
Facility Name
Novartis Investigative Site
City
Bologna
Country
Italy
Facility Name
Novartis Investigative Site
City
Monza
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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