Trial Outcomes & Findings for Dasatinib in Relapsed Chronic Lymphocytic Leukemia (NCT NCT00438854)

Last Updated: 2017-12-13

Results Overview

Overall objective response rate in terms of complete response, nodular partial response, and partial response to treatment. Objective response is when a biopsy shows. In general response is defined as the following (not complete criteria): Complete response (CR) requires all of the following for a period of at least 2 months: * Absence of lymphadenopathy * No hepatomegaly or splenomegaly * Absence of constitutional symptoms * Normal complete blood count Nodular partial response (nPR): Met the criteria for CR, but had residual bone marrow biopsy nodules as the only evidence of disease Partial response (PR): requires at least the following: * 50% decrease in peripheral blood lymphocyte count * 50% reduction in lymphadenopathy * 50% reduction in the size of the liver and/or spleen

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

2 years

Results posted on

2017-12-13

Participant Flow

Started recruitment 12/2006 and ended recruitment 12/2008. Patients were recruited from the clinics of the Massachusetts General Hospital and the Dana Farber Cancer Institute.

Patients signing the consent form were screened for eligibility. If eligible, they were started on protocol. This is a single-arm protocol.

Participant milestones

Participant milestones
Measure	Dasatinib Treatment All patients were treated with Dasatinib pills by mouth as treatment. Dasatinib: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dasatinib in Relapsed Chronic Lymphocytic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dasatinib Treatment n=15 Participants All patients were treated with Dasatinib pills by mouth as treatment. Dasatinib: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	60.67 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Dasatinib Treatment n=15 Participants All patients were treated with dasatinib pills by mouth as treatment. Dasatinib: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects.
Overall Objective Response	3 participants who responded

SECONDARY outcome

Timeframe: 1 year

The number of participants with a 100% reduction in nodal mass.

Outcome measures

Outcome measures
Measure	Dasatinib Treatment n=15 Participants All patients were treated with dasatinib pills by mouth as treatment. Dasatinib: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects.
Complete Response Rate	0 Participants

SECONDARY outcome

Timeframe: 1 year

The median time to disease progression, measured from the start of treatment.

Outcome measures

Outcome measures
Measure	Dasatinib Treatment n=15 Participants All patients were treated with dasatinib pills by mouth as treatment. Dasatinib: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects.
Median Time to Disease Progression	7.5 Months Interval 0.6 to 34.4

SECONDARY outcome

Timeframe: 3 years

The median survival time, as measured from the start of treatment until death from any cause.

Outcome measures

Outcome measures
Measure	Dasatinib Treatment n=15 Participants All patients were treated with dasatinib pills by mouth as treatment. Dasatinib: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects.
Median Overall Survival	27 Months Interval 1.1 to 47.5

Adverse Events

Dasatinib Treatment

Serious events: 10 serious events

Other events: 15 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Dasatinib Treatment n=15 participants at risk All patients were treated with dasatinib pills by mouth as treatment. Dasatinib: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects.
Investigations Neutrophil count decreased	40.0% 6/15 • From the start of treatment until the participant is taken off study due to disease progression, toxicity, participant withdrawal, or death; median duration of 14 weeks. Participants were assessed for adverse events with the use of physical exams, laboratory tests, and participant self reporting of adverse events
Investigations Platelet count decreased	13.3% 2/15 • From the start of treatment until the participant is taken off study due to disease progression, toxicity, participant withdrawal, or death; median duration of 14 weeks. Participants were assessed for adverse events with the use of physical exams, laboratory tests, and participant self reporting of adverse events
Cardiac disorders Electrocardiogram QT corrected interval prolonged	6.7% 1/15 • From the start of treatment until the participant is taken off study due to disease progression, toxicity, participant withdrawal, or death; median duration of 14 weeks. Participants were assessed for adverse events with the use of physical exams, laboratory tests, and participant self reporting of adverse events
Metabolism and nutrition disorders Hyperkalemia	6.7% 1/15 • From the start of treatment until the participant is taken off study due to disease progression, toxicity, participant withdrawal, or death; median duration of 14 weeks. Participants were assessed for adverse events with the use of physical exams, laboratory tests, and participant self reporting of adverse events

Other adverse events

Other adverse events
Measure	Dasatinib Treatment n=15 participants at risk All patients were treated with dasatinib pills by mouth as treatment. Dasatinib: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects.
Blood and lymphatic system disorders Anemia	93.3% 14/15 • From the start of treatment until the participant is taken off study due to disease progression, toxicity, participant withdrawal, or death; median duration of 14 weeks. Participants were assessed for adverse events with the use of physical exams, laboratory tests, and participant self reporting of adverse events
Investigations Neutrophil count decreased	46.7% 7/15 • From the start of treatment until the participant is taken off study due to disease progression, toxicity, participant withdrawal, or death; median duration of 14 weeks. Participants were assessed for adverse events with the use of physical exams, laboratory tests, and participant self reporting of adverse events
Investigations Platelet Count Decreased	86.7% 13/15 • From the start of treatment until the participant is taken off study due to disease progression, toxicity, participant withdrawal, or death; median duration of 14 weeks. Participants were assessed for adverse events with the use of physical exams, laboratory tests, and participant self reporting of adverse events
Gastrointestinal disorders Nausea /vomiting	80.0% 12/15 • From the start of treatment until the participant is taken off study due to disease progression, toxicity, participant withdrawal, or death; median duration of 14 weeks. Participants were assessed for adverse events with the use of physical exams, laboratory tests, and participant self reporting of adverse events
Gastrointestinal disorders Heartburn	33.3% 5/15 • From the start of treatment until the participant is taken off study due to disease progression, toxicity, participant withdrawal, or death; median duration of 14 weeks. Participants were assessed for adverse events with the use of physical exams, laboratory tests, and participant self reporting of adverse events
Gastrointestinal disorders Diarrhea	60.0% 9/15 • From the start of treatment until the participant is taken off study due to disease progression, toxicity, participant withdrawal, or death; median duration of 14 weeks. Participants were assessed for adverse events with the use of physical exams, laboratory tests, and participant self reporting of adverse events
Respiratory, thoracic and mediastinal disorders Dyspnea	60.0% 9/15 • From the start of treatment until the participant is taken off study due to disease progression, toxicity, participant withdrawal, or death; median duration of 14 weeks. Participants were assessed for adverse events with the use of physical exams, laboratory tests, and participant self reporting of adverse events
Respiratory, thoracic and mediastinal disorders Pleural effusion	26.7% 4/15 • From the start of treatment until the participant is taken off study due to disease progression, toxicity, participant withdrawal, or death; median duration of 14 weeks. Participants were assessed for adverse events with the use of physical exams, laboratory tests, and participant self reporting of adverse events
General disorders Fatigue	86.7% 13/15 • From the start of treatment until the participant is taken off study due to disease progression, toxicity, participant withdrawal, or death; median duration of 14 weeks. Participants were assessed for adverse events with the use of physical exams, laboratory tests, and participant self reporting of adverse events
Respiratory, thoracic and mediastinal disorders Pneumonitis	13.3% 2/15 • From the start of treatment until the participant is taken off study due to disease progression, toxicity, participant withdrawal, or death; median duration of 14 weeks. Participants were assessed for adverse events with the use of physical exams, laboratory tests, and participant self reporting of adverse events
Nervous system disorders Headache	33.3% 5/15 • From the start of treatment until the participant is taken off study due to disease progression, toxicity, participant withdrawal, or death; median duration of 14 weeks. Participants were assessed for adverse events with the use of physical exams, laboratory tests, and participant self reporting of adverse events
Skin and subcutaneous tissue disorders Rash	40.0% 6/15 • From the start of treatment until the participant is taken off study due to disease progression, toxicity, participant withdrawal, or death; median duration of 14 weeks. Participants were assessed for adverse events with the use of physical exams, laboratory tests, and participant self reporting of adverse events
General disorders Edema	20.0% 3/15 • From the start of treatment until the participant is taken off study due to disease progression, toxicity, participant withdrawal, or death; median duration of 14 weeks. Participants were assessed for adverse events with the use of physical exams, laboratory tests, and participant self reporting of adverse events

Additional Information

Philip C. Amrein, M.D.

Massachusetts General Hospital

Phone: 617-726-8748

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place