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

NCT ID: NCT03547154

Last Updated: 2019-08-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 344 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-10-22
• Study Completion Date: 2001-02-20

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pegylated interferon alfa-2b

Participants received pegylated interferon alfa-2b (PEG Intron) at a dose of 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Participants may have received hydroxyurea therapy as needed prior to randomization to reduce or keep the white blood cell (WBC) count ≤50,000/μl. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Pegylated interferon alfa-2b

Intervention Type: BIOLOGICAL

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

Interferon alfa-2b

Participants received interferon alfa-2b (Intron\^® A), recombinant for injection, at a dose of 5 million international units (MIU)/m\^2, administered daily by SC injection. Participants may have received hydroxyurea therapy as needed prior to randomization to reduce or keep the WBC count ≤50,000/μl. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.

Group Type: ACTIVE_COMPARATOR

Interferon alfa-2b

Intervention Type: BIOLOGICAL

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

Interventions

Pegylated interferon alfa-2b

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

Intervention Type: BIOLOGICAL

Interferon alfa-2b

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

Intervention Type: BIOLOGICAL

Other Intervention Names

PEG Intron; INTRON^® A

Eligibility Criteria

Inclusion Criteria

• Has chronic phase CML diagnosed within 3 months prior to study enrollment
• Has chronic phase CML positive for Ph^1 as confirmed by cytogenetic studies, performed by a central laboratory
• Has platelet count >/= 50,000/microl
• Has hemoglobin >/= 9.0 g/dL
• Has WBC count >/=2000/microl but </= 50,000/microl
• Has adequate hepatic and renal function, as defined by the following parameters obtained within 14 days prior to initiation of study treatment

• serum glutamic oxaloacetic transaminase (SGOT) <2 times upper limit of laboratory normal (ULN)
• serum glutamic pyruvic transaminase SGPT <2 times upper ULN
• serum bilirubin <2 times ULN
• serum creatinine <2.0 mg/dL
• Is fully recovered from any prior major surgery and must be at least 4 weeks postoperative
• Has Eastern Cooperative Oncology Group Performance Status of 0-2
• Has signed a written, voluntary informed consent before study entry, is willing to participate in this study, and is willing to complete all follow-up assessments

Exclusion Criteria

• Has accelerated phase CML as defined by any of the following criteria.

• peripheral blood myeloblasts >/=15%
• peripheral blood basophils >/= 20%
• peripheral blood myeloblasts plus promyelocytes >/=30%
• platelets <100,000/microl, unrelated to therapy
• Has blastic phase CML (30% myeloblasts in peripheral blood or bone marrow)
• Is a candidate for and is planning to receive allogeneic, syngeneic, or autologous bone marrow transplantation within the next 12 months
• Has received prior treatment for their CML, except for hydroxyurea (collection of stem cells without using high dose chemotherapy for mobilization is acceptable)
• Has severe cardiovascular disease (i. e., arrhythmias requiring chronic treatment, congestive heart failure [New York Heart Association (NYHA) Class III or IV], or symptomatic ischemic heart disease)
• Has a history of a neuropsychiatric disorder requiring hospitalization
• Has thyroid dysfunction not responsive to therapy
• Has uncontrolled diabetes mellitus
• Has a history of seropositivity for human immunodeficiency virus
• Has active and/or uncontrolled infection, including active hepatitis
• Has a medical condition requiring chronic systemic corticosteroids
• Has a history of prior malignancies within the last 5 years, except for surgically cured non-melanoma skin cancer, or cervical carcinoma in situ
• Has received any experimental therapy within 30 days prior to enrollment in this study
• Is known to be actively abusing alcohol or drugs
• Is pregnant, nursing, or of reproductive potential and is not practicing an effective means of contraception

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK-4031-001

Identifier Type: OTHER

Identifier Source: secondary_id

C98-026

Identifier Type: OTHER

Identifier Source: secondary_id

C98026

Identifier Type: -

Identifier Source: org_study_id