Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Dasatinib (Sprycel) in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (NCT NCT00918463)

Last Updated: 2018-08-31

Results Overview

Response rate will be used as a measure of efficacy of dasatinib monotherapy in relapsed or refractory aggressive Diffuse Large B-Cell Lymphoma (DLBCL)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

2 years

Results posted on

2018-08-31

Participant Flow

Participant milestones

Participant milestones
Measure	All Patients dasatinib: 100 mg daily dosing
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	All Patients dasatinib: 100 mg daily dosing
Overall Study Death	1
Overall Study Lack of Efficacy	1

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of Dasatinib (Sprycel) in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=2 Participants dasatinib: 100 mg daily dosing
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Data was not collected due to early termination of the study.

Response rate will be used as a measure of efficacy of dasatinib monotherapy in relapsed or refractory aggressive Diffuse Large B-Cell Lymphoma (DLBCL)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Data was not collected due to early termination of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Data was not collected due to early termination of the study.

Outcome measures

Outcome data not reported

Adverse Events

All Patients

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Patients n=2 participants at risk dasatinib: 100 mg daily dosing
Vascular disorders Hypotension	50.0% 1/2 • Number of events 1 Zero subjects at risk for "Other (Not Including Serious) Adverse Events" as subjects were not evaluated due to early study termination.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	50.0% 1/2 • Number of events 1 Zero subjects at risk for "Other (Not Including Serious) Adverse Events" as subjects were not evaluated due to early study termination.
Renal and urinary disorders Acute renal failure	50.0% 1/2 • Number of events 1 Zero subjects at risk for "Other (Not Including Serious) Adverse Events" as subjects were not evaluated due to early study termination.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Peter Martin

Weill Cornell Medicine

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place