Status:
COMPLETED
An Extension Study to Determine the Efficacy and Safety of STI571 in Participants With Chronic Myeloid Leukemia Who Are Refractory to or Intolerant of Interferon-Alpha
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
During the Core Phase of the study, participants received STI571 at a dose of 400 milligrams (mg) daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue trea...
Eligibility Criteria
Inclusion
- Participants included in the study were:
- Consenting males or females greater than or equal to (≥)18 years of age with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML).
- With a documented failure of interferon-alpha (IFN) or an IFN-containing therapy, characterized as resistance or refractoriness defined as any of the following:
- Hematologic Resistance - Failure to achieve a complete hematological response (CHR), lasting for at least 1 month despite 6 or more months of IFN or an IFN-containing regimen, in which IFN was administered at a dose of at least 25 million international units (MIU) per week. During this treatment period the cumulative duration of hydroxyurea therapy may not have exceeded 50% of the treatment period with the IFN-containing regimen.
- Cytogenetic Resistance - Bone marrow cytogenetics showing ≥65% Ph+ after one year of IFN-based therapy,
- Cytogenetic Refractoriness - An increase in the Ph+ chromosome in BM cells by at least 30 percentage points (e.g. from 20% to 50%, or from 30% to 60%) confirmed by two samples at least 1 month apart, or an absolute increase to ≥65%,
- Hematologic Refractoriness - A rising white blood cell count (WBC) \[to a level ≥20 x 10\^9/L confirmed by two samples taken at least two weeks apart\] for participants achieving a complete hematologic response while receiving IFN or an IFN-containing regimen. This regimen must have included IFN at a dose of at least 25 MIU administered per week. During this treatment period the cumulative duration of hydroxyurea therapy may not have exceeded 50% of the treatment period with the IFN-containing regimen.
- In this report all refractory populations were referred to as "relapsed" populations.
- With a documented intolerance to IFN therapy defined as a ≥Grade 3 non-hematologic toxicity persisting for at least one month, for participants receiving IFN or an IFN- containing regimen. IFN was to be administered at a dose of at least 25 MIU/week. Participants who were intolerant of IFN were to have been diagnosed ≥6 months prior to the time of entry into the study.
Exclusion
- Participants excluded from the study were:
- Females of childbearing potential without a negative pregnancy test prior to the initiation of study drug. Barrier contraceptive precautions were to be used throughout the trial in both sexes.
- With serum bilirubin and creatinine concentrations more than twice the upper limit of the normal range (ULN).
- With serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) more than twice the ULN.
- With \>15% of blasts or basophils in peripheral blood (PB) or bone marrow (BM).
- With ≥30% of blasts plus promyelocytes in PB or BM.
- With a platelet count of less than (\<)100 x 10\^9/L.
- With an Eastern Cooperative Oncology Group (ECOG) Performance Status Score ≥3.
- Receiving busulfan within 6 weeks of Day 1.
- Receiving treatment with IFN or cytosine arabinoside (Ara-C) within 14 days of Day 1.
- Receiving treatment with hydroxyurea within 7 days of Day 1.
- Receiving other investigational agents within 28 days of Day 1.
- With prior marrow or stem cell transplantation.
Key Trial Info
Start Date :
December 6 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2013
Estimated Enrollment :
532 Patients enrolled
Trial Details
Trial ID
NCT00171223
Start Date
December 6 1999
End Date
November 29 2013
Last Update
July 22 2021
Active Locations (28)
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1
UCLA Medical Center
Los Angeles, California, United States, 90095
2
H. Lee Moffet Cancer Center & Research Institute/Univ of South Florida
Tampa, Florida, United States, 33612
3
Northwestern Univ meical School/Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, United States, 60611
4
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231