PEG-Intron For Chronic Myelogenous Leukemia Patients Unresponsive To Or Intolerant Of Roferon Or Intron

Stopped early · Phase 2

Conditions studied: Leukemia, Myeloid, Philadelphia-Positive

In brief

The purpose of this study is to determine if PEG-Intron is better tolerated and more efficacious than standard interferons (Roferon, Intron) in patients with Philadelphia-positive Chronic Myelogenous Leukemia. These patients should have previously received standard interferon therapy and have been intolerant, resistant, or have relapsed disease.

Key facts

Study ID

NCT00037882

Run by

M.D. Anderson Cancer Center

People needed

1

Starts

2001-02-01

Expected to finish

2003-12-03

Last updated by the study team

2018-11-01

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic phase CML, documented by the presence of Philadelphia chromosome or bcr/abl rearrangement at time of diagnosis, confirmed by either cytogenetics or PCR.
• WBC >/= 3000/ul </=100,000/ul.
• Patients must have received prior interferon therapy \& proven to have primary refractory disease, secondary resistance or intolerance to interferon-a
• Patient must have ECOG status of 0, 1, or 2
• Labs: SGOT/SGPT<2xULN; serum bilirubin<2xULN; serum creatinine <2.0mg/dl
• Recovered from effects of major surgery
• Life expectancy > 12 wks.
• Signed informed consent.
• Women of childbearing potential must have negative serum pregnancy test within 72 hrs prior to administration of PEG-Intron \& use effective contraception during the study.

You may not qualify if…

• NO accelerated Phase CML patients with peripheral blood: blasts>/=15%, basophils>/=20%, blasts+promyelocytes>/=30%, platelets<100,000/ul (unrelated to therapy). Blastic phase CML:>/=30% in peripheral blood/bone marrow.
• NO patients with known hypersensitivity to interferon-a.
• NO severe cardiovascular disease, i.e. arrhythmias requiring chronic treatment or congestive heart failure (NYHA classification III/IV).
• NO history of neuropsychiatric disorder requiring hospitalization.
• NO patients requiring therapy for refractory thyroid dysfunction
• NO patients with uncontrolled diabetes mellitus.
• NO patients who have had treatment for a 2nd malignancy in the past 5 yrs, except for localized basal cell/squamous cell carcinoma of the skin or cervical carcinoma in situ.
• NO pregnant or lactating patients.
• NO patients known to be actively using alcohol or drugs
• NO patients receiving any experimental therapy within 30 days of enrollment in study.

Where it is running

• M. D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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