Trial Outcomes & Findings for Imatinib Mesylate Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia (NCT NCT00022490)

Results Overview

Cytogenetic response is defined in terms of the percentage of Philadelphia (Ph) chromosome. Major cytogenetic response is defined as 0-34% Ph-positive cells.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

6 months

Results posted on

2016-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	Cytarabine/ Imatinib Mesylate Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Imatinib Mesylate Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cytarabine/ Imatinib Mesylate n=24 Participants Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Cytogenetic response is defined in terms of the percentage of Philadelphia (Ph) chromosome. Major cytogenetic response is defined as 0-34% Ph-positive cells.

Outcome measures

Outcome measures
Measure	Cytarabine/ Imatinib Mesylate n=24 Participants Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months
The Rate of Major Cytogenetic Response at 6 Months	5 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 and 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 and 12 months

Outcome measures

Outcome data not reported

Adverse Events

Cytarabine/ Imatinib Mesylate

Serious events: 13 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cytarabine/ Imatinib Mesylate n=24 participants at risk Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months
Blood and lymphatic system disorders Neutropenia	16.7% 4/24
Blood and lymphatic system disorders Thrombocytopenia	16.7% 4/24
Skin and subcutaneous tissue disorders Hyperbilirubinemia	8.3% 2/24
Musculoskeletal and connective tissue disorders Bone Pain	4.2% 1/24
Gastrointestinal disorders Diarrhea	4.2% 1/24
General disorders Fatigue	4.2% 1/24

Other adverse events

Adverse event data not reported

Additional Information

Dr. Brian Druker

OHSU Knight Cancer Institute

Phone: (503) 494 5596

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place