Pegasys in Patients With Chronic Myeloid Leukemia (CML)

This study has been terminated.
(Slow Accrual)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01392170
First received: July 8, 2011
Last updated: April 13, 2015
Last verified: April 2015
Results First Received: March 31, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia
Intervention: Drug: PEG-IFNá-2a

  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
Recruitment Period: October 28, 2011 to March 28, 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study was terminated due to slow accrual.

Reporting Groups
  Description
PEG-IFNá-2a PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.

Participant Flow:   Overall Study
    PEG-IFNá-2a  
STARTED     2  
COMPLETED     0  
NOT COMPLETED     2  
Withdrawal by Subject                 1  
Ineligible                 1  



  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.
No text entered.

Reporting Groups
  Description
PEG-IFNá-2a PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.

Baseline Measures
    PEG-IFNá-2a  
Number of Participants  
[units: participants]
  2  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     2  
>=65 years     0  
Gender  
[units: participants]
 
Female     2  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     2  



  Outcome Measures

1.  Primary:   Number of Participants Achieved of Major Molecular Response (MMR) or Complete Molecular Response (CMR)   [ Time Frame: 12 months from start of treatment with PEG-IFNá-2a ]


  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
Early termination due to slow accrual, no analysis possible.


  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: Alfonso Quintas-Cardama, MD/Professor, Leukemia
Organization: University of Texas (UT) MD Anderson Cancer Center
phone: 713-745-4009
e-mail: CR_Study_Registration@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01392170     History of Changes
Other Study ID Numbers: 2011-0184, NCI-2011-01465
Study First Received: July 8, 2011
Results First Received: March 31, 2015
Last Updated: April 13, 2015
Health Authority: United States: Institutional Review Board