Clinical trial · Interventional
PEG-Intron For Chronic Myelogenous Leukemia Patients Unresponsive To Or Intolerant Of Roferon Or Intron
A Phase II Study of SCH 54031 (Peg Interferon Alpha-2B/PEG-Intron) in Subjects With Interferon-Refractory Chronic Myelogenous Leukemia
NCT00037882CI-TRIAL-00035595terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Philadelphia-Positive | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEG-Intron | Drug | Peginterferon Alfa-2b | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SCH 54031
- description
- Peg Interferon Alpha-2B/PEG-Intron
- interventionNames
- Drug: PEG-Intron
Primary outcomes (1)
- measure
- Efficacy
- timeFrame
- 2 Years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.