Campath Maintenance in Chronic Lymphocytic Leukemia

This study has been terminated.
(Insufficient recruitment.)
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Kanti Rai, MD, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00587847
First received: December 21, 2007
Last updated: September 16, 2015
Last verified: September 2015
Results First Received: May 29, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Lymphocytic Leukemia
Intervention: Drug: Campath

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was originally designed to recruit 20 patients but only 12 subjects were accrued to the trial before it was stopped due to poor recruitment. Subjects were entered between August 2005 and July 2007. All subjects had Chronic Lymphocytic Leukemia that was previously treated with chemotherapy.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Single Arm, Open Label Trial. single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.

Participant Flow:   Overall Study
    Single Arm, Open Label Trial.  
STARTED     12  
COMPLETED     5  
NOT COMPLETED     7  
Lack of Efficacy                 5  
Adverse Event                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
This was a pilot study with enrollment goal of 20 based on our patient population with potential to meet inclusion criteria. This goal was not met due to patient preferance for no further treatment which is standard of care.

Reporting Groups
  Description
Single Arm, Open Label Trial. single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.

Baseline Measures
    Single Arm, Open Label Trial.  
Number of Participants  
[units: participants]
  12  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     6  
>=65 years     6  
Gender  
[units: participants]
 
Female     3  
Male     9  
Region of Enrollment  
[units: participants]
 
United States     12  



  Outcome Measures
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1.  Primary:   Time to Progression (Months)   [ Time Frame: Every 8 weeks ]

2.  Secondary:   Rate of Infections   [ Time Frame: Weekly then every 2 weeks then every 3 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Trial was terminated early due to poor accrual.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kanti Rai, MD
Organization: North Shore-Long Island Jewish Health System
phone: (718) 470-4050
e-mail: krai@nshs.edu



Responsible Party: Kanti Rai, MD, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00587847     History of Changes
Other Study ID Numbers: 05.10.030
Berlex Study# 106.0621 ( Other Identifier: Berlex )
Study First Received: December 21, 2007
Results First Received: May 29, 2013
Last Updated: September 16, 2015
Health Authority: United States: Food and Drug Administration