Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

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

Chromosome Aberrations

Chronic Graft Versus Host Disease

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.

Overall Survival by Dose in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia

Lymphoid Blast Crisis 400 mg

Acute Lymphoblastic Leukemia 400 mg

Lymphoid Blast Crisis 600 mg

Acute Lymphoblastic Leukemia 600 mg

Acute Myeloid/Myelogenous Leukemia 600 mg

Overall Study

Anti-Infective Agents

Interferons

Interferon-alpha

Adult Ph+CML pts in CCgR after IFN alpha.

Long term outcom after interferon alpha discontinuation or not

Interpheron alpha

Domenico Russo

Objectives

This is an observational study aimed at updating the overall survival (OS), the progression free survival (PFS) to accelerated-blastic (AB) phase and the complete cytogenetic response (CCgR) duration of the CML patients who between 1986 and 2001 were treated with an IFN based therapy (either alone or in combination) and who obtained a CCgR. It also aims at analysing the clinical and biological features of this selected cohort of patients with persisting CCgR after treatment with IFN.

Study design This study is an observational retrospective multicenter study.

Assessment and Follow-up Patients' demographic data and retrospective collection of CML cytogenetic and molecular data will be reported in the "Assessment and Follow-up FORM".

In this FORM the events related to therapy, disease and survival will also be reported.

Duration of the study:

The recruitment period is estimated in approximately 2 years.

Study rational

* IFN, either alone or in combination with AC, prolonged survival of Ph+ CML patients, in early chronic phase, mainly in those patients achieving the CCgR
* CCgR became the surrogate marker for survival duration and the main target of IFN therapy
* CCgR were rare events accounting for less than 10% of the cytogenetic responsive patients
* These cases can be considered as a fascinating elite of patients who have the highest sensitivity to IFN and are the most likely candidates for prolonged survival and possibly cure
* From 1986 to 2001, more than 1200 CML patients either enrolled in different national trials or referred in single Institutions have been treated frontline with IFN based therapy
* In 2001, data on 317 CCgRs were reported by the EICML group
* They included 214 cases treated with IFN alone collected from the database of 9 national study groups in Austria, Belgium, Netherlands, France, Germany, Italy, Spain, Sweden and United Kingdom and 103 cases treated with IFN alone collected from single Institutions in Italy, France, and United Kingdom.
* The study did not include the patients achieving CCgR with IFN + LDAC
* The contribution of Italy was of 119 cases: 59 from national studies and 60 from single Institutions
* The follow-up of these patients is stopped at 2000 and from 2000 thereafter almost CML patients were treated with IM
* We don't know if the patients who had achieved a CCgR with IFN based therapy continued or discontinued IFN, or crossed to IM therapy
* We don't know if they maintained a CCgR with or without therapy
* We don't know if the patients who achieved a CCgR with IFN and crossed to IM had the same cytogenetic and molecular response, PFS and OS as the majority of the patients unresponsive to IFN who were treated with IM
* We don't know the clinical and biological features of these selected cohort of patients

Follow-up of Ph+ Chronic Myleoid Leukemia Patients in Complete Cytogenetic Response With Interferon Based Therapy

Long Term Follow-up of Ph+ CML Patients Achieving Complete Cytogenetic Remission With Interferon Based Therapy

One primary outcome measure is the PFS of the CML patients who between 1986 and 2001 were treated with IFN based therapy (either alone or in combination) and who obtained the CCgR.

One primary outcome measure is the duration of CCgR of the CML patients who between 1986 and 2001 were treated with IFN based therapy (either alone or in combination) and who obtained the CCgR.

OS will be calculated from the date of diagnosis until date of death (whatever the cause). Patients still alive will be censored at the moment of last follow-up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Follow-up of Ph+ Chronic Myleoid Leukemia Patients in Complete Cytogenetic Response With Interferon Based Therapy	NCT01490853	Chronic Myeloid...	Interpheron alp...	18 Years -	Università degli Studi di Brescia

Spots Global Cancer Trial Database for philadelphia positive chronic myeloid leukemia