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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00037882
Recruitment Status : Terminated
First Posted : May 27, 2002
Last Update Posted : August 1, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

May 24, 2002
May 27, 2002
August 1, 2012
February 2001
October 2003   (Final data collection date for primary outcome measure)
Efficacy [ Time Frame: 2 Years ]
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Complete list of historical versions of study NCT00037882 on Archive Site
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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
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.
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Leukemia, Myeloid, Philadelphia-Positive
Drug: PEG-Intron
Once weekly injection.
Other Names:
  • SCH 54031
  • Peg Interferon Alpha-2B
Experimental: SCH 54031
Peg Interferon Alpha-2B/PEG-Intron
Intervention: Drug: PEG-Intron
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2003
October 2003   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United States
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M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Study Chair: Razelle Kurzrock, M.D. UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP