Leukemia, Myeloid, Philadelphia-Positive Clinical Trial
Official title:
A Phase II Study of SCH 54031 (Peg Interferon Alpha-2B/PEG-Intron) in Subjects With Interferon-Refractory Chronic Myelogenous Leukemia
Verified date | October 2018 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | December 3, 2003 |
Est. primary completion date | December 3, 2003 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | M. D. Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | Schering-Plough |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy | 2 Years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT00297570 -
Imatinib Versus Imatinib and Peg-Interferon in Patients With Ph+ CML and Complete Cytogenetic Response After Imatinib Therapy
|
Phase 3 |