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Trial record 28 of 1274 for:    IFNA2

Pegasys in Patients With Chronic Myeloid Leukemia (CML)

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ClinicalTrials.gov Identifier: NCT01392170
Recruitment Status : Terminated (Slow Accrual)
First Posted : July 12, 2011
Results First Posted : April 14, 2015
Last Update Posted : May 4, 2015
Sponsor:
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
Enrollment 2
Recruitment Details 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 Study was terminated due to slow accrual.
Arm/Group Title PEG-IFNá-2a
Hide Arm/Group Description PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
Period Title: Overall Study
Started 2
Completed 0
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Ineligible             1
Arm/Group Title PEG-IFNá-2a
Hide Arm/Group Description PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
2
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Number of Participants Achieved of Major Molecular Response (MMR) or Complete Molecular Response (CMR)
Hide Description Molecular response defined as: major molecular response (MMR) corresponds to a BCR-ABL1/ABL1 ratio of <=0.01. Complete molecular response (CMR) is defined as undetectable BCR-ABL1 transcripts. Molecular response measured every 3 months (a total of 4 assessments within one year of therapy).
Time Frame 12 months from start of treatment with PEG-IFNá-2a
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated due to low accrual. No participants were evaluable for outcome.
Arm/Group Title PEG-IFNá-2a
Hide Arm/Group Description:
PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event collection through 30 days post treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PEG-IFNá-2a
Hide Arm/Group Description PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
All-Cause Mortality
PEG-IFNá-2a
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PEG-IFNá-2a
Affected / at Risk (%)
Total   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PEG-IFNá-2a
Affected / at Risk (%)
Total   0/2 (0.00%) 
Early termination due to slow accrual, no analysis possible.
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
ClinicalTrials.gov 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