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A Phase II Study of SCH 54031 (Peg Interferon Alpha-2B/PEG-Intron) in Subjects With Interferon-Refractory Chronic Myelogenous Leukemia

Phase 2
Not Enrolling
Leukemia, Myeloid, Philadelphia-Positive

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Trial Information

A Phase II Study of SCH 54031 (Peg Interferon Alpha-2B/PEG-Intron) in Subjects With Interferon-Refractory Chronic Myelogenous Leukemia

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

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
- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

2 Years

Safety Issue:


Principal Investigator

Razelle Kurzrock, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2001

Completion Date:

December 2003

Related Keywords:

  • Leukemia, Myeloid, Philadelphia-Positive
  • Chronic Myelogenous Leukemia
  • Interferon alpha
  • Roferon
  • Intron
  • Chronic Myelogenous Leukemia-Philadelphia positive
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive



M. D. Anderson Cancer Center Houston, Texas  77030