An Extension Study to Determine the Safety and Anti-Leukemic Effects of Imatinib Mesylate in Adult Participants With Ph+ Leukemia

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).

Time frame: Up to 3 years after start of treatment

Population: ITT population consisted of all enrolled participants. The data for this outcome measure was collected and analyzed in participants who belonged to the disease group of Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg or 600 mg only, as pre-specified in the protocol. The other three acute leukemia disease groups were exploratory only.~Data is reported with data that is available. No additional data tables were found that could provide results with arms broken down any further.

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 frame: Up to 3 years after start of treatment

Population: ITT population consisted of all enrolled participants. The data for this outcome measure was collected and analyzed in participants who belonged to the disease group of Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg or 600 mg only, as pre-specified in the protocol. The other three acute leukemia disease groups were exploratory only.~Data is reported with data that is available. No additional data tables were found that could provide results with arms broken down any further.

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: 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156 months after start of treatment

Population: ITT population consisted of all enrolled participants. The data for this outcome measure was collected and analyzed in participants by disease groups.~Data is reported with data that is available. No additional data tables were found that could provide results with arms broken down any further.

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: 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132 months after start of treatment

Population: ITT population consisted of all enrolled participants. The overall survival was calculated as per initial dose (400 mg or 600 mg) only for participants with Accelerated Phase Chronic Myeloid/Myelogenous Leukemia, as pre-specified in the protocol.~Data is reported with data that is available. No additional data tables were found that could provide results with arms broken down any further.

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 not be assigned. Cytogenetic response was defined as confirmed complete or partial response. A BM sample was considered as assessable for cytogenetic response only if it contained ≥20 metaphases. However, an assessment of partial response was retained in a sample with \<20 metaphases when it was immediately preceded or followed by a complete or partial response in another sample with ≥20 metaphases.

Time frame: Up to 3 years after start of treatment

Population: ITT population consists of all enrolled participants. The data for this outcome measure was collected and analyzed in participants who belonged to the disease group of Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg or 600 mg only, as pre-specified in the protocol. The other three acute leukemia disease groups were exploratory only.~Data is reported with data that is available. No additional data tables were found that could provide results with arms broken down any further.

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.

Time frame: Up to 3 years after start of treatment

Population: ITT population consisted of all enrolled participants. The data for this outcome measure was collected and analyzed in participants who belonged to the disease group of Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg or 600 mg only, as pre-specified in the protocol. The other three acute leukemia disease groups were exploratory only.~Data is reported with data that is available. No additional data tables were found that could provide results with arms broken down any further.

Time to response was defined for all participants as the time until first documented response (which was confirmed ≥4 weeks later).

Time frame: Up to 3 years after start of treatment

Population: ITT population consisted of all enrolled participants. The data for this outcome measure was collected and analyzed in participants who belonged to the disease group of Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg or 600 mg only, as pre-specified in the protocol. The other three acute leukemia disease groups were exploratory only.~Data is reported with data that is available. No additional data tables were found that could provide results with arms broken down any further.