Pegasys in Patients With Chronic Myeloid Leukemia (CML)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01392170
Recruitment Status : Terminated (Slow Accrual)
First Posted : July 12, 2011
Results First Posted : April 14, 2015
Last Update Posted : May 4, 2015
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Leukemia
Intervention: Drug: PEG-IFNá-2a

  Participant Flow

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

Participant Flow:   Overall Study
Withdrawal by Subject                1 
Ineligible                1 

  Baseline Characteristics

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

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   2 
>=65 years   0 
[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

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

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

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01392170     History of Changes
Other Study ID Numbers: 2011-0184
NCI-2011-01465 ( Registry Identifier: NCI CTRP )
First Submitted: July 8, 2011
First Posted: July 12, 2011
Results First Submitted: March 31, 2015
Results First Posted: April 14, 2015
Last Update Posted: May 4, 2015