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

NCT00171158 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: CSTI571A0102E22005-001380-61
• Study Type: interventional
• Target: 260
• Locations: 4 countries
• Sites: 10

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.

Conditions

Philadelphia Chromosome Positive CML

Keywords

Chronic Myelogenous Leukemia; CML; Philadelphia Chromosome; Blast crisis; Imatinib mesylate

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (1)

Imatinib Mesylate (STI571)

EXPERIMENTAL

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

Interventions

imatinib mesylate DRUG

Also known as: Gleevec/Glivec

Imatinib Mesylate (STI571)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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
• \. 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.
• \. 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.
• \. A negative pregnancy test in participants of childbearing potential.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (10)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Dana Faber Institute

Boston, Massachusetts, 02115, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

Poitiers, France

Location

Novartis Investigative Site

Frankfurt am Main, Germany

Location

Novartis Investigative Site

Leipzig, Germany

Location

Novartis Investigative Site

Mannheim, Germany

Location

Novartis Investigative Site

München, Germany

Location

Novartis Investigative Site

Bologna, Italy

Location

Novartis Investigative Site

Monza, Italy

Location

MeSH Terms

Conditions

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

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Translocation, Genetic; Chromosome Aberrations; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: July 26, 1999
• Primary Completion: April 1, 2013
• Study Completion: April 22, 2013
• Last Updated: June 25, 2021
• Results First Posted: June 25, 2021

Record last verified: 2021-06

Locations

DE (4); US (3); IT (2); FR (1)