NCT00037882

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2001

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2002

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2003

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

2.8 years

First QC Date

May 24, 2002

Last Update Submit

October 31, 2018

Conditions

Leukemia, Myeloid, Philadelphia-Positive

Keywords

Chronic Myelogenous LeukemiaInterferon alphaRoferonIntronChronic Myelogenous Leukemia-Philadelphia positive

Outcome Measures

Primary Outcomes (1)

  • Efficacy

    2 Years

Study Arms (1)

SCH 54031

EXPERIMENTAL

Peg Interferon Alpha-2B/PEG-Intron

Drug: PEG-Intron

Interventions

PEG-IntronDRUG

Once weekly injection.

Also known as: SCH 54031, Peg Interferon Alpha-2B
SCH 54031

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Razelle Kurzrock, M.D.

    UT MD Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2002

First Posted

May 27, 2002

Study Start

February 1, 2001

Primary Completion

December 3, 2003

Study Completion

December 3, 2003

Last Updated

November 1, 2018

Record last verified: 2018-10

Locations

US(1)