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

Primary Purpose

Leukemia, Myeloid, Philadelphia-Positive

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PEG-Intron
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Philadelphia-Positive focused on measuring Chronic Myelogenous Leukemia, Interferon alpha, Roferon, Intron, Chronic Myelogenous Leukemia-Philadelphia positive

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • M. D. Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SCH 54031

Arm Description

Peg Interferon Alpha-2B/PEG-Intron

Outcomes

Primary Outcome Measures

Efficacy

Secondary Outcome Measures

Full Information

First Posted
May 24, 2002
Last Updated
October 31, 2018
Sponsor
M.D. Anderson Cancer Center
Collaborators
Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
NCT00037882
Brief Title
PEG-Intron For Chronic Myelogenous Leukemia Patients Unresponsive To Or Intolerant Of Roferon Or Intron
Official Title
A Phase II Study of SCH 54031 (Peg Interferon Alpha-2B/PEG-Intron) in Subjects With Interferon-Refractory Chronic Myelogenous Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Study Start Date
February 2001 (Actual)
Primary Completion Date
December 3, 2003 (Actual)
Study Completion Date
December 3, 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Schering-Plough

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Philadelphia-Positive
Keywords
Chronic Myelogenous Leukemia, Interferon alpha, Roferon, Intron, Chronic Myelogenous Leukemia-Philadelphia positive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SCH 54031
Arm Type
Experimental
Arm Description
Peg Interferon Alpha-2B/PEG-Intron
Intervention Type
Drug
Intervention Name(s)
PEG-Intron
Other Intervention Name(s)
SCH 54031, Peg Interferon Alpha-2B
Intervention Description
Once weekly injection.
Primary Outcome Measure Information:
Title
Efficacy
Time Frame
2 Years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Razelle Kurzrock, M.D.
Organizational Affiliation
UT MD Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
M. D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
Public website for M.D.Anderson Cancer Center

Learn more about this trial

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

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