Polyethylene Glycol Interferon Alfa-2b (PEG Intron) Versus Interferon Alfa-2b (INTRON^® A) in the Treatment of Newly Diagnosed Chronic Myelogenous Leukemia (CML) (C98026)

NCT03547154 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 344

Last updated 2019-08-12

Study results available
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Summary

The primary purpose of this study is to compare the efficacy of polyethylene glycol (PEG; pegylated) interferon alfa-2b (PEG Intron, C98026) versus interferon alfa-2b (Intron® A) in the treatment of participants with newly diagnosed CML.

Conditions

  • Chronic Myelogenous Leukemia

Interventions

BIOLOGICAL

Pegylated interferon alfa-2b

Weekly SC injection of pegylated interferon alfa-2b, 6.0 microg/kg

BIOLOGICAL

Interferon alfa-2b

Daily SC injection of interferon alfa-2b, 5 MIU/m\^2

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-10-22
Primary Completion
2001-02-20
Completion
2001-02-20
FDA Drug
Yes

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03547154 on ClinicalTrials.gov