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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00037882
• Other study ID #: DM00-150
• Status: Terminated
• Phase: Phase 2
• Start date: February 2001
• Est. completion date: December 3, 2003

Study information

• Verified date: October 2018
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Philadelphia-Positive

Intervention

Drug:
• PEG-Intron
Once weekly injection.

Locations

Country	Name	City	State
United States	M. D. Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Schering-Plough

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy		2 Years

External Links

•   Public website for M.D.Anderson Cancer Center