Trial Outcomes & Findings for Pegasys in Patients With Chronic Myeloid Leukemia (CML) (NCT NCT01392170)

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

12 months from start of treatment with PEG-IFNá-2a

Results posted on

2015-05-04

Participant Flow

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

Study was terminated due to slow accrual.

Participant milestones

Participant milestones
Measure	PEG-IFNá-2a PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	PEG-IFNá-2a PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
Overall Study Withdrawal by Subject	1
Overall Study Ineligible	1

Baseline Characteristics

Pegasys in Patients With Chronic Myeloid Leukemia (CML)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PEG-IFNá-2a n=2 Participants PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months from start of treatment with PEG-IFNá-2a

Population: Study terminated due to low accrual. No participants were evaluable for outcome.

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).

Outcome measures

Outcome data not reported

Adverse Events

PEG-IFNá-2a

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alfonso Quintas-Cardama, MD/Professor, Leukemia

University of Texas (UT) MD Anderson Cancer Center

Phone: 713-745-4009

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place