Trial Outcomes & Findings for Dasatinib in Treating Patients With Chronic Lymphocytic Leukemia (NCT NCT01441882)

Last Updated: 2021-04-08

Results Overview

Defined by a decrease in absolute lymphocyte count, as determined by peripheral blood complete blood count (CBC) with differential or by bone marrow examination of 50 % and/or a decrease of detectable total lymph node size or spleen size by 50% (either by clinical examination contrast enhanced computed tomography \[CT\]).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

8 weeks

Results posted on

2021-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Dasatinib) Patients receive dasatinib PO QD during course 1 and if tolerated, BID in subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Dasatinib: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Overall Study STARTED	19
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dasatinib in Treating Patients With Chronic Lymphocytic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Dasatinib) n=13 Participants Patients receive dasatinib PO QD during course 1 and if tolerated, BID in subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Dasatinib: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	62.6 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome measures
Measure	Treatment (Dasatinib) n=13 Participants Patients receive dasatinib PO QD during course 1 and if tolerated, BID in subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Dasatinib: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
The Number of Participants With In Vitro Dasatinib Sensitivity in Predicting Clinical Activity ABS lymph ct decrease > 50%	4 Participants
The Number of Participants With In Vitro Dasatinib Sensitivity in Predicting Clinical Activity In vitro dasatinib sensitivity in predicting clini	5 Participants
The Number of Participants With In Vitro Dasatinib Sensitivity in Predicting Clinical Activity Total lymph size decrease > 50%	4 Participants
The Number of Participants With In Vitro Dasatinib Sensitivity in Predicting Clinical Activity Spleen decrease by > 50%	0 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Proportion of patients achieving the endpoint along with its 95% exact binomial confidence interval will be presented. Complete Response (CR): present \>=2 mos: no symptoms of CLL, normal findings on exam, ALC \< 4.000/mm3, ANC \>1.500/ mm3, platelet (PLT) count (ct) \>100.000/ mm3, hemoglobin (Hgb) concentration \>11 g/dL (untransfused), bone marrow (BM) lymphocytosis \<30%, and no nodules (lymphoid aggregates) on BM biopsy. Partial Response (PR): present \>=2 months: a reduction in prev. enlarged nodes, spleen, \& liver by at least 50%. ANC \>= 1.500/ mm3 or PLT ct \>= 100.000/ mm3 or Hgb concentration \>=11 g/dL or 50% improvement over pre-therapy reductions in Hgb concentration and/or PLT ct. Nodular PR: persistent BM nodules or infiltrates seen on BM biopsy those achieving a CR or PR. Stable Disease (SD): Does not meet CR or PR, but also not progressive disease (PD). PD: 50% size increase of lymph node, spleen, liver; or histologic (e.g. Richter's) transformation (per NCI and iwCLL).

Outcome measures

Outcome measures
Measure	Treatment (Dasatinib) n=13 Participants Patients receive dasatinib PO QD during course 1 and if tolerated, BID in subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Dasatinib: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Objective Response Complete Response (CR)	0 Participants
Objective Response Partial Response (PR)	2 Participants
Objective Response Partial Response with Lymphocytosis (PR-L)	2 Participants
Objective Response Stable Disease (SD)	8 Participants
Objective Response Progression	1 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: Given the significant evolution of the treatment landscape, overall survival was no longer deemed to be a worthwhile/meaningful endpoint. Patients were lost to follow up and data was not collected.

Kaplan-Meier method will be used to estimate the survival curve.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Kaplan-Meier method will be used to estimate the survival curve.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 4 years

Assessed According to the NCI Common Terminology Criteria for Adverse Events Version 4.0. Adverse events will be tabulated and summarized according to key reporting criteria (i.e., grade or seriousness, unanticipated, treatment attribution). Refer to the Adverse Event tables below for specific details.

Outcome measures

Outcome measures
Measure	Treatment (Dasatinib) n=13 Participants Patients receive dasatinib PO QD during course 1 and if tolerated, BID in subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Dasatinib: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Incidence of Adverse Events (Number of Participants Affected)	8 Participants

Adverse Events

Treatment (Dasatinib)

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Dasatinib) n=13 participants at risk Patients receive dasatinib PO QD during course 1 and if tolerated, BID in subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Dasatinib: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
Skin and subcutaneous tissue disorders Facial Swelling	7.7% 1/13 • Number of events 1 • Adverse events were collected within 30 days of discontinuation of study drug, up to 4 years. Adverse events were tabulated and summarized according to key reporting criteria (i.e., grade or seriousness, unanticipated, treatment attribution).
Gastrointestinal disorders Colitis	7.7% 1/13 • Number of events 1 • Adverse events were collected within 30 days of discontinuation of study drug, up to 4 years. Adverse events were tabulated and summarized according to key reporting criteria (i.e., grade or seriousness, unanticipated, treatment attribution).
General disorders Fatigue	15.4% 2/13 • Number of events 2 • Adverse events were collected within 30 days of discontinuation of study drug, up to 4 years. Adverse events were tabulated and summarized according to key reporting criteria (i.e., grade or seriousness, unanticipated, treatment attribution).
Metabolism and nutrition disorders Hypocalcemia	7.7% 1/13 • Number of events 1 • Adverse events were collected within 30 days of discontinuation of study drug, up to 4 years. Adverse events were tabulated and summarized according to key reporting criteria (i.e., grade or seriousness, unanticipated, treatment attribution).
Blood and lymphatic system disorders Edema	7.7% 1/13 • Number of events 1 • Adverse events were collected within 30 days of discontinuation of study drug, up to 4 years. Adverse events were tabulated and summarized according to key reporting criteria (i.e., grade or seriousness, unanticipated, treatment attribution).
Blood and lymphatic system disorders Bilateral leg edema	7.7% 1/13 • Number of events 1 • Adverse events were collected within 30 days of discontinuation of study drug, up to 4 years. Adverse events were tabulated and summarized according to key reporting criteria (i.e., grade or seriousness, unanticipated, treatment attribution).
Blood and lymphatic system disorders Leukocytosis	7.7% 1/13 • Number of events 1 • Adverse events were collected within 30 days of discontinuation of study drug, up to 4 years. Adverse events were tabulated and summarized according to key reporting criteria (i.e., grade or seriousness, unanticipated, treatment attribution).
Blood and lymphatic system disorders Thrombocytopenia	15.4% 2/13 • Number of events 2 • Adverse events were collected within 30 days of discontinuation of study drug, up to 4 years. Adverse events were tabulated and summarized according to key reporting criteria (i.e., grade or seriousness, unanticipated, treatment attribution).
Blood and lymphatic system disorders Neutropenia	7.7% 1/13 • Number of events 1 • Adverse events were collected within 30 days of discontinuation of study drug, up to 4 years. Adverse events were tabulated and summarized according to key reporting criteria (i.e., grade or seriousness, unanticipated, treatment attribution).
Blood and lymphatic system disorders Anemia	15.4% 2/13 • Number of events 2 • Adverse events were collected within 30 days of discontinuation of study drug, up to 4 years. Adverse events were tabulated and summarized according to key reporting criteria (i.e., grade or seriousness, unanticipated, treatment attribution).
Blood and lymphatic system disorders Hyperkalemia	7.7% 1/13 • Number of events 1 • Adverse events were collected within 30 days of discontinuation of study drug, up to 4 years. Adverse events were tabulated and summarized according to key reporting criteria (i.e., grade or seriousness, unanticipated, treatment attribution).
Eye disorders Conjunctivitis	7.7% 1/13 • Number of events 1 • Adverse events were collected within 30 days of discontinuation of study drug, up to 4 years. Adverse events were tabulated and summarized according to key reporting criteria (i.e., grade or seriousness, unanticipated, treatment attribution).
Infections and infestations Pneumonia	7.7% 1/13 • Number of events 1 • Adverse events were collected within 30 days of discontinuation of study drug, up to 4 years. Adverse events were tabulated and summarized according to key reporting criteria (i.e., grade or seriousness, unanticipated, treatment attribution).
General disorders vasovagal reaction	7.7% 1/13 • Number of events 1 • Adverse events were collected within 30 days of discontinuation of study drug, up to 4 years. Adverse events were tabulated and summarized according to key reporting criteria (i.e., grade or seriousness, unanticipated, treatment attribution).
Skin and subcutaneous tissue disorders basal cell carcinoma	7.7% 1/13 • Number of events 1 • Adverse events were collected within 30 days of discontinuation of study drug, up to 4 years. Adverse events were tabulated and summarized according to key reporting criteria (i.e., grade or seriousness, unanticipated, treatment attribution).

Other adverse events

Adverse event data not reported

Additional Information

Stephen Spurgeon

Oregon Health & Science University

Phone: 503-494-4606

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place