Trial Outcomes & Findings for A Study of Dasatinib and Rituximab for Relapsed/Refractory Chronic Lymphocytic Leukemia (NCT NCT00949988)

NCT ID: NCT00949988

Last Updated: 2019-08-14

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2019-08-14

Participant Flow

Participant milestones

Measure	All Participants This study only enrolled three subjects and all three subjects withdrew before study completion.
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	All Participants This study only enrolled three subjects and all three subjects withdrew before study completion.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

A Study of Dasatinib and Rituximab for Relapsed/Refractory Chronic Lymphocytic Leukemia

Baseline characteristics by cohort

Measure	All Participants n=3 Participants This study only enrolled three subjects and all three subjects withdrew before study completion.
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	2 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: This study only enrolled three participants and all three participants withdrew. No data analysis was performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: This study only enrolled three participants and all three participants withdrew. No data analysis was performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: This study only enrolled three participants and all three participants withdrew. No data analysis was performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: This study only enrolled three participants and all three participants withdrew. No data analysis was performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: This study only enrolled three participants and all three participants withdrew. No data analysis was performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: This study only enrolled three participants and all three participants withdrew. No data analysis was performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: This study only enrolled three participants and all three participants withdrew. No data analysis was performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: This study only enrolled three participants and all three participants withdrew. No data analysis was performed.

Phase II:

To determine the efficacy of D+R treatment in patients with relapsed/refractory CLL as measured by complete and partial response rates

Outcome measures

Outcome data not reported

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Participants n=3 participants at risk This study only enrolled three subjects and all three subjects withdrew before study completion.
General disorders Rigors	33.3% 1/3 • Number of events 1
Ear and labyrinth disorders Sialoadenitis	33.3% 1/3 • Number of events 1
Blood and lymphatic system disorders Thrombocytopenia	33.3% 1/3 • Number of events 1

Additional Information

Kimberly Aguilar, Clinical Trials Manager

UCSD Moores Cancer Center

Phone: 858-534-5201

Email: k1aguilar@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place