Trial Outcomes & Findings for Hydroxychloroquine in Untreated B-CLL Patients (NCT NCT00771056)

Results Overview

Percentage of participants with a reduction of the absolute lymphocytic count- ALC

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

1 yr

Results posted on

2016-08-22

Participant Flow

Recruitment was from April 2009 through termination December 2011. Patients were identified and enrolled in the CLL Research and Treatment Program where they already were being seen for care of their CLL.

Participant milestones

Participant milestones
Measure	Hydroxychloroquine Hydroxychloroquine 400 mg po daily for up to one year.
Overall Study STARTED	23
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hydroxychloroquine in Untreated B-CLL Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hydroxychloroquine n=23 Participants Hydroxychloroquine 400 mg po daily for up to one year.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 yr

Percentage of participants with a reduction of the absolute lymphocytic count- ALC

Outcome measures

Outcome measures
Measure	Hydroxychloroquine n=23 Participants Hydroxychloroquine 400 mg po daily for up to one year.
Percentage of Participants With Response	54.4 percentage of participants

SECONDARY outcome

Timeframe: 1 yr

Population: only analyzed for participants that were treated within one year post last dose of hydroxychloroquine dose

number of months to time from last HCQ dose to next CLL treatment

Outcome measures

Outcome measures
Measure	Hydroxychloroquine n=3 Participants Hydroxychloroquine 400 mg po daily for up to one year.
Time to Next Treatment	4.3 months Interval 2.0 to 7.0

Adverse Events

Hydroxychloroquine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kanti R Rai, MD

Northwell Health (formerly North Shore LIJ Health System)

Phone: (718)470-4050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place