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

This study has been terminated.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: May 24, 2002
Last updated: July 31, 2012
Last verified: July 2012
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.

Condition Intervention Phase
Leukemia, Myeloid, Philadelphia-Positive
Drug: PEG-Intron
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of SCH 54031 (Peg Interferon Alpha-2B/PEG-Intron) in Subjects With Interferon-Refractory Chronic Myelogenous Leukemia

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 2 Years ]

Enrollment: 1
Study Start Date: February 2001
Study Completion Date: December 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SCH 54031
Peg Interferon Alpha-2B/PEG-Intron
Drug: PEG-Intron
Once weekly injection.
Other Names:
  • SCH 54031
  • Peg Interferon Alpha-2B

Detailed 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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00037882

United States, Texas
M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Study Chair: Razelle Kurzrock, M.D. UT MD Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00037882     History of Changes
Other Study ID Numbers: DM00-150
Study First Received: May 24, 2002
Last Updated: July 31, 2012

Keywords provided by M.D. Anderson Cancer Center:
Chronic Myelogenous Leukemia
Interferon alpha
Chronic Myelogenous Leukemia-Philadelphia positive

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017