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

Philadelphia Chromosome Positive CML Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171158
• Other study ID #: CSTI571A0102E2
• Secondary ID: 2005-001380-61
• Status: Completed
• Phase: Phase 2
• Start date: July 26, 1999
• Est. completion date: April 22, 2013

Study information

• Verified date: June 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: April 22, 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blast Crisis
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Philadelphia Chromosome
• Philadelphia Chromosome Positive CML

Intervention

Drug:
• imatinib mesylate

Locations

Country	Name	City	State
France	Novartis Investigative Site	Poitiers
Germany	Novartis Investigative Site	Frankfurt/Main
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Mannheim
Germany	Novartis Investigative Site	Muenchen
Italy	Novartis Investigative Site	Bologna
Italy	Novartis Investigative Site	Monza
United States	Dana Faber Institute	Boston	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From first dose until death of the patient, up to 14 years.
Primary	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.	From first dose until death of the patient, up to 14 years.