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
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.
It has been shown that patients who experience complete hematologic or at least a partial cytogenetic response to interferon will have improved survival times. In addition, evidence exists that even patients who do not demonstrate a cytogenetic response to interferon treatment can still benefit from treatment, in terms of survival, compared to patients not treated with interferon. This indicates that if a patient is better able to tolerate interferon, he or she may have improved survival even without cytogenetic response. Preliminary studies suggest that PEG-Intron is more convenient for patients (administered once weekly rather than daily), is better tolerated than interferon, and can produce hematologic remission in interferon-a resistant patients. Phase II studies are needed to ascertain the overall hematologic and cytogenetic response rates to PEG-Intron in such patients. ;
| 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 |