Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Philadelphia Chromosome

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Translocation, Genetic

Chromosome Aberrations

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Antisickling Agents

Hematinics

Amino Acids

Cytarabine

Interferons

Hydroxyurea

Interferon-alpha

Imatinib Mesylate

Iron-Dextran Complex

Interferon alpha-2

Antiviral Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10\^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m\^2/day (max 40 mg) SC injection for 10 days every month. Maximum study duration was 11.5 years.

In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m\^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10\^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.

imatinib supplied as 100 mg and 400 mg tablets or 100 mg capsules.

imatinib mesilate

interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day.

interferon-alpha (INF-a)

cytarabine 20 mg/m\^2/day (max 40 mg) SC for 10 days every month.

cytarabine (ARA-C)

Novartis Pharmaceuticals

The purpose of this study is to evaluate and compare the side effects and anti-leukemic benefits of imatinib with those of interferon and Ara-C for patients who have chronic myeloid leukemia (CML) in the chronic phase. Patients in this study will be randomized (1:1) to receive either interferon plus Ara-C or imatinib as initial treatment.

Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia

A Phase III Study of STI571 Versus Interferon-α (IFN-α) Combined With Cytarabine (Ara-C) in Patients With Newly Diagnosed Previously Untreated Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Overall survival was defined as the time between date of randomization and death due to any cause. The time was censored at last examination date for patients who were still being treated and at date of last contact for patients who discontinued treatment. Kaplan-Meier estimates of the percentage of participants at each time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.

Event-free survival is defined as the time between randomization and the earliest of any of the following events on treatment:

* progression to Accelerated Phase (AP) or Blast Crisis (BC)
* loss of Complete Hematological Response (CHR)
* loss of Major Cytogenetic Response (MCyR) confirmed
* loss of Major Cytogenetic Response (MCyR) unconfirmed
* increase in white blood cell count (WBC) if approved by the Study Management Committee (SMC)
* death (due to any cause when reported as primary reason for discontinuation of treatment).

Kaplan Meier estimates of the percentage of participants with Event Free Survival at the given time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.

Event-free survival is defined as the time between randomization and the earliest of any of the following events on treatment:

* progression to Accelerated Phase (AP) or Blast Crisis (BC)
* loss of Complete Hematological Response (CHR)
* loss of Major Cytogenic Response (MCyR) confirmed
* loss of Major Cytogenic Response (MCyR) unconfirmed
* increase in white blood cell count (WBC) if approved by the Study Management Committee (SMC)
* death (due to any cause when reported as primary reason for discontinuation of treatment).

The percentage of participants with Event Free Survival events in each category was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.

Time to progression to AP/BC is defined as the time between randomization and either of the following events on treatment: death (due to CML when reported as primary reason for discontinuation of treatment) or progression to Accelerated Phase or Blast Crisis and is censored at last examination date for patients without event. No data after discontinuation of study treatment was included. The Kaplan Meier estimates of the percentage of participants with survival without progression to AP/BC at the given time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.

Bone marrow aspirate was performed to evaluate cytogenetic results (percentage of Philadelphia chromosome positive (Ph+) metaphases) and amount of blasts and promyelocytes in bone marrow to establish cytogenetic response.

Major Cytogenetic Response= Complete Response or Partial Response. Complete Cytogenetic Response= 0 % of Ph+ metaphases (out of 20 metaphases). Partial Cytogenetic Response= \> 0 and ≤ 35 % of Ph+ metaphases (out of 20 metaphases). The percentage of participants with cytogenetic response in each category was calculated.

Bone marrow aspirate was performed to evaluate cytogenetic results (percentage of Ph chromosome (Ph+) containing metaphases) and the amount of blasts and promyelocytes in bone marrow to establish cytogenetic response.

Major Cytogenetic Response= Complete Response or Partial Response. Complete Cytogenetic Response= 0 % of Ph+ metaphases (out of 20 metaphases). Partial Cytogenetic Response= \> 0 and ≤ 35 % Ph+ metaphases (out of 20 metaphases). The percentage of participants with cytogenetic response in each category was calculated.

A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant

Major Molecular Response was determined using a quantitative polymerase chain reaction (PCR) laboratory test and was defined as BCR-ABL protein transcripts of ≤ 0.1% according to the international scale.

In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10\^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C) in the second-line treatment period. Maximum study duration was 11.5 years.

Imatinib (STI571)

IFN-a + Ara-C

In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10\^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m\^2/day (max 40 mg) SC injections for 10 days every month.

Imatinib to IFN-a + Ara-C

In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m\^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10\^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.

IFN-a + Ara-C to Imatinib

In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10\^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.

In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m\^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10\^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (CSI151). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.

Total

Age Continuous

Sex: Female, Male

Study Director

12 months (n = 553, 553)

24 months (n = 542, 512)

36 months (n = 518, 471)

48 months (n = 492, 441)

60 months (n = 475, 411)

72 months (n = 461, 388)

84 months (n = 446, 373)

96 months (n = 430, 358)

108 months (n = 391, 315)

120 months (n = 368, 299)

132 months (n = 356, 288)

144 months (n = 250, 199)

Intent-to-treat population included all randomized participants. n = number of participants at risk at the beginning of the specific time interval

Kaplan-Meier Estimates of Overall Survival (All Randomized Participants)

24 months (n = 505, 332)

36 months (n = 448, 263)

48 months (n = 415, 241)

60 months (n = 395, 223)

72 months (n = 376, 207)

84 months (n = 352, 181)

96 months (n = 334, 166)

108 months (n = 301, 141)

120 months (n = 269, 130)

132 months (n = 257, 124)

144 months (n = 143, 76)

Kaplan Meier Estimates of Event Free Survival (All Randomized Participants)

Participants with events

Progression to AP or BC

Loss of CHR

Loss of MCyR (confirmed)

Loss of MCyR (unconfirmed)

Increase of WBC

Death

Intent-to-treat population included all randomized participants.

Percentage of Participants With Event Free Survival Events (All Randomized Participants)

24 months (n = 513, 388)

36 months (n = 461, 337)

48 months (n = 431, 311)

60 months (n = 409, 289 )

72 months (n = 384, 265)

84 months (n = 358, 236)

96 months (n = 338, 220)

108 months (n = 305, 189)

120 months (n = 272, 175)

132 months (n = 259, 165)

144 months (n = 145, 94)

Kaplan Meier Estimates of Time to Progression to Accelerated Phase (AP) or Blast Crisis (BC) (All Randomized Participants)

Major Cytogenic Response

Complete Cytogenic Response

Partial Cytogenic Response

Intent-to-treat participants included all randomized participants.

Percentage of Participants With Best Cytogenetic Response (First-line Treatment)

Percentage of Participants With Best Cytogenetic Response (Second-line Treatment)

Safety Population included all randomized participants who received study drug.

Number of Participants With Serious Adverse Events as a Measure of Safety (First-line Treatment)

In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10\^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 mu/m\^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m\^2/day (max 40 mg) SC injection for 10 days every month in the second-line treatment period.

Number of Participants With Serious Adverse Events as a Measure of Safety (Second-line Treatment)

12 months (n= 305, 83)

24 months (n= 102, 12)

36 months (n= 68, 7)

48 months (n= 305, 12)

60 months (n= 316, 10)

72 months (n= 292, 9)

84 months (n= 247, 8)

96 months (n= 228, 4)

108 months (n= 233, 0)

120 months (n= 204, 0)

132 months (n= 168, 0)

144 months (n= 1, 0)

Percentage of Participants With Major Molecular Response (First-line Treatment)

12 months (n = 86)

24 months (n = 62)

36 months (n = 130)

48 months (n = 216)

60 months (n = 174)

72 months (n = 146)

84 months (n = 139)

96 months (n = 138)

108 months (n = 120)

120 months (n = 84)

132 months (n = 31)

144 months

Intent-to-treat population included all randomized participants. No participants in the imatinib to IFN-a + Ara-C arm were available for testing.

Percentage of Participants With Major Molecular Response (Second-line Treatment)

First-line Treatment Period

Second-line Treatment Period

Desmoplastic Small Round Cell Tumor

Sarcoma

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Imatinib mesilate

An open-label, non-comparative study conducted to investigate the activity and safety of imatinib mesylate in refractory desmoplastic small round cell tumors expressing PDGF-R. Patients will be treated up to 12 months, or to disease progression. Tumor will be evaluated according to Recist criteria

Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors

Open-label Trial of Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors (DSRCT) Expressing PDGF-R

An imaging technique (CT scan or MRI) determined tumor response according to RECIST criteria.

Recorded survival after treatment and other associated treatment modalities.

Assessed actual resectability rate after therapy compared to resectability before therapy.

External Affairs

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia	NCT00333840	Chronic Myeloge...	imatinib mesila... interferon-alph... cytarabine (ARA...	18 Years - 70 Years	Novartis
Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia	NCT00333840	Chronic Myeloge...	imatinib mesila... interferon-alph... cytarabine (ARA...	18 Years - 70 Years	Novartis
Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors	NCT00417807	Refractory Desm...	Imatinib mesila...	16 Years -	Novartis

Spots Global Cancer Trial Database for imatinib mesilate