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Hydroxychloroquine in Untreated B-CLL Patients

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ClinicalTrials.gov Identifier: NCT00771056
Recruitment Status : Terminated (study suspended while data is reviewed for safety and efficacy.)
First Posted : October 10, 2008
Results First Posted : July 26, 2016
Last Update Posted : August 22, 2016
Sponsor:
Information provided by (Responsible Party):
Kanti Rai, MD, Northwell Health

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition B-Cell Chronic Lymphocytic Leukemia
Intervention Drug: Hydroxychloroquine
Enrollment 23
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Hydroxychloroquine
Hide Arm/Group Description Hydroxychloroquine 400 mg po daily for up to one year.
Period Title: Overall Study
Started 23
Completed 18
Not Completed 5
Arm/Group Title Hydroxychloroquine
Hide Arm/Group Description Hydroxychloroquine 400 mg po daily for up to one year.
Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
  69.6%
>=65 years
7
  30.4%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 23 participants
59
(44 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
6
  26.1%
Male
17
  73.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants
23
1.Primary Outcome
Title Percentage of Participants With Response
Hide Description Percentage of participants with a reduction of the absolute lymphocytic count- ALC
Time Frame 1 yr
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hydroxychloroquine
Hide Arm/Group Description:
Hydroxychloroquine 400 mg po daily for up to one year.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: percentage of participants
54.4
2.Secondary Outcome
Title Time to Next Treatment
Hide Description number of months to time from last HCQ dose to next CLL treatment
Time Frame 1 yr
Hide Outcome Measure Data
Hide Analysis Population Description
only analyzed for participants that were treated within one year post last dose of hydroxychloroquine dose
Arm/Group Title Hydroxychloroquine
Hide Arm/Group Description:
Hydroxychloroquine 400 mg po daily for up to one year.
Overall Number of Participants Analyzed 3
Mean (Full Range)
Unit of Measure: months
4.3
(2 to 7)
Time Frame Adverse event reporting wil be reported if applicable as subjects are monitored on a monthly basis.
Adverse Event Reporting Description Subjects were monitored monthly by physician for adverse events from hydroxychloroquine.
 
Arm/Group Title Hydroxychloroquine
Hide Arm/Group Description

Hydroxychloroquine 400 mg po daily for up to one year.

Hydroxychloroquine: 400mg by mouth daily x 1 year

All-Cause Mortality
Hydroxychloroquine
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Hydroxychloroquine
Affected / at Risk (%)
Total   0/23 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hydroxychloroquine
Affected / at Risk (%)
Total   0/23 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kanti R Rai, MD
Organization: Northwell Health (formerly North Shore LIJ Health System)
Phone: (718)470-4050
EMail: krai@nshs.edu
Layout table for additonal information
Responsible Party: Kanti Rai, MD, Northwell Health
ClinicalTrials.gov Identifier: NCT00771056    
Other Study ID Numbers: 08-088
First Submitted: October 8, 2008
First Posted: October 10, 2008
Results First Submitted: December 17, 2015
Results First Posted: July 26, 2016
Last Update Posted: August 22, 2016