18 and older, any sex, with Philadelphia Positive Chronic Myeloid Leukemia or Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Hematologic Response in Accelerated Phase Chronic Myeloid/Myelogenous LeukemiaPrimary· Up to 3 years after start of treatment
Hematologic response was evaluated from hematology measurements in the peripheral blood (PB) and bone marrow (BM) and assessments of extramedullary leukemic involvement (EMD) at physical examination. Response was defined as complete hematologic remission (CHR), no evidence of leukemia (NEL), or return to chronic phase (RTC).
Percentage of Participants With Cytogenetic Response in Accelerated Phase Chronic Myeloid/Myelogenous LeukemiaSecondary· Up to 3 years after start of treatment
Bone marrow (BM) cytogenetic analysis was required at baseline, after 12 weeks (visit 22) and after 24 weeks (visit 28) to evaluate Ph chromosome positivity. In several participants, this was also done after 4 and 8 weeks. Based on the percentage of Philadelphia chromosome positive (Ph+) cells = (positive cells/examined cells)x100, at each BM assessment the cytogenetic response was classified as: Complete, 0% Ph+ cells; Partial, \>0 - 35% Ph+ cells; Minor, \>35 - 65% Ph+ cells; Minimal, \>65 - 95% Ph+ cells; None, \>95% Ph+ cells; Not done: \<20 metaphases were examined and/or response could n
Duration of Response in Participants With Accelerated Phase Chronic Myeloid/Myelogenous LeukemiaSecondary· Up to 3 years after start of treatment
Duration of response was defined as the time between first documented response (which was confirmed ≥4 weeks later) and the earliest date of the following: loss of response (when any of the criteria for response were no longer fulfilled); progression to blast crisis (≥30% blasts in peripheral blood or bone marrow, extramedullary involvement other than liver/spleen enlargement); discontinuation due to adverse event, laboratory abnormality, unsatisfactory therapeutic effect or death.
Time to Progression to Blast Crisis in Participants With Accelerated Phase Chronic Myeloid/Myelogenous LeukemiaSecondary· Up to 3 years after start of treatment
Progression to blast crisis was defined as ≥30% blasts in peripheral blood or bone marrow or as extramedullary involvement other than liver or spleen enlargement.
Overall Survival by DiseaseSecondary· 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156 months after start of treatment
To evaluate overall survival, all participants were followed after the last dose of study drug every month for the first three months and thereafter every three months until death. Overall survival was calculated for all participants as the time between start of treatment and death due to any reason. The time was censored at the date of last contact for participants who discontinued treatment and were in survival follow-up. For participants without survival follow-up information, the time was censored at last available visit/treatment date.
Overall Survival by Dose in Participants With Accelerated Phase Chronic Myeloid/Myelogenous LeukemiaSecondary· 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132 months after start of treatment
To evaluate overall survival, all participants were followed after the last dose of study drug every month for the first three months and thereafter every three months until death. Overall survival was calculated for all participants as the time between start of treatment and death due to any reason. The time was censored at the date of last contact for participants who discontinued treatment and were in survival follow-up. For participants without survival follow-up information, the time was censored at last available visit/treatment date.
Time frame: Up to approximately 14 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
STI571
Serious: 20/293 (7%)
Deaths: —
Serious adverse events (18 terms)
Reaction
System
STI571
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Death
General disorders
—
Subdural haematoma
Injury, poisoning and procedural complications
—
Transfusion reaction
Injury, poisoning and procedural complications
—
Breast cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Gastrointestinal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The objectives of Part 1 of the study were:
* To determine the rate of hematologic response (HR) lasting ≥4 weeks in participants with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the accelerated phase (AP).
* To evaluate duration of HR, overall survival, cytogenetic response (CyR), time to blast crisis in CML participants in the AP, improvement of symptomatic parameters, tolerability and safety of STI571 treatment.
The objective of the extension (Part 2) was:
-To enable participants to have access to study drug and continue study treatment and to decrease data collection to include only overall survival and serious adverse events.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 22 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00171249.