Neoplasms

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Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Philadelphia Chromosome

Leukemia, Myeloid, Accelerated Phase

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Translocation, Genetic

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Myeloid Leukemia

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Non Lymphoblastic Leukemia

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

Lymphosarcoma

Chronic Myeloproliferative Disorders

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Imatinib Mesylate

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.

Participants with lymphoid blast crisis received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.

Participants with acute lymphoblastic leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.

Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.

Participants with lymphoid blast crisis received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.

Participants with acute lymphoblastic leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.

Participants with acute myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.

STI571 400 mg

STI571 600 mg

Novartis Pharmaceuticals

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.

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

An Extension to a Phase II Study to Determine the Safety and Anti-Leukemic Effects of STI571 in Adult Patients With Philadelphia Chromosome Positive Leukemia Including Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Accelerated Phase Chronic Myeloid 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).

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

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.

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.

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.

AEs were not collected separately for each disease and dose groups of participants. The data has been reported as originally produced by the team at the time of reporting. We have exhausted all efforts to locate additional data; therefore, no additional data is available to report or modify what has previously been reported. No other non-serious AEs were collected during extension phase within clinical database.

Participants received STI571 400/600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.

Note- Data is reported with data that is available. No additional data tables were found that could provide results 'per arm' , therefore a summary arm has been reported.

STI571

Age, Continuous

Sex: Female, Male

Intention-to-treat (ITT) population consisted of all enrolled participants. Baseline characteristics were collected and reported together for each disease and dose groups (Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg or 600 mg, Lymphoid Blast Crisis 400 mg or 600 mg, Acute Lymphoblastic Leukemia 400 mg or 600 mg, and Acute Myeloid/Myelogenous Leukemia 600 mg) of participants, as pre-specified in the protocol.

Study Director

Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg

Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 600 mg

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.

Percentage of Participants With Hematologic Response in Accelerated Phase Chronic Myeloid/Myelogenous Leukemia

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.

Percentage of Participants With Cytogenetic Response in Accelerated Phase Chronic Myeloid/Myelogenous Leukemia

Hematologic response

Cytogenetic response

Time to Response in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia

Duration of Response in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia

Time to Progression to Blast Crisis in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia

12 months

24 months

36 months

48 months

60 months

72 months

84 months

96 months

108 months

120 months

132 months

144 months

156 months

Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 400/600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.

Accelerated Phase Chronic Myeloid/Myelogenous Leukemia

Participants with lymphoid blast crisis received STI571 400/600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.

Lymphoid Blast Crisis

Participants with acute lymphoid leukemia received STI571 400/600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.

Acute Lymphoid Leukemia

Acute Myeloid/Myelogenous Leukemia

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.

Overall Survival by Disease

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
An Extension Study to Determine the Safety and Anti-Leukemic Effects of Imatinib Mesylate in Adult Participants With Ph+ Leukemia	NCT00171249	Philadelphia Po... Acute Lymphobla... Acute Myeloid L...	STI571 400 mg STI571 600 mg	18 Years -	Novartis
An Extension Study to Determine the Safety and Anti-Leukemic Effects of Imatinib Mesylate in Adult Participants With Ph+ Leukemia	NCT00171249	Philadelphia Po... Acute Lymphobla... Acute Myeloid L...	STI571 400 mg STI571 600 mg	18 Years -	Novartis

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