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 | Terminated Phase 2 Results FDA Drug

• 3 other identifiers: C98026MK-4031-001C98-026
• Study Type: interventional
• Target: 344
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months

  Cytogenetic response (CR) was defined by the degree of suppression of Philadelphia chromosome (Ph\^1) achieved during study treatment. For all participants continuing treatment after study conclusion, cytogenetic assessments were conducted locally as per standard of care. Determination of CR at 12 months were based on cytogenetic analysis of bone marrow aspirate samples. The CR criteria were based on the percentage (%) of PH\^1-positive cells during study treatment. Protocol-defined CR criteria were Complete Response (0%), Partial Response (1-34%), Minor Response (35-90%), or No Response (\>90%). Data for the analysis population was based on the intent-to-treat principle. Participants who were treatment failures at 6 months were considered cytogenetic non-responders. Recording of CR was independent of hematologic responses.

  Up to 12 months

Secondary Outcomes (3)

• Number of Participants With Cytogenetic Response (CR) to PEG Intron and Intron A at 6 Months

  6 months

• Number of Participants With Hematologic Responses to PEG Intron and Intron A at 6 Months

  6 months

• Number of Participants With Overall Survival

  Up to 2 years (24 months), and beyond

Study Arms (2)

Pegylated interferon alfa-2b

EXPERIMENTAL

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.

Biological: Pegylated interferon alfa-2b

Interferon alfa-2b

ACTIVE COMPARATOR

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.

Biological: Interferon alfa-2b

Interventions

Pegylated interferon alfa-2b BIOLOGICAL

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

Also known as: PEG Intron

Pegylated interferon alfa-2b

Interferon alfa-2b BIOLOGICAL

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

Also known as: INTRON^® A

Interferon alfa-2b

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

peginterferon alfa-2b; Interferon alpha-2

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

AE Preferred Terms were converted from WHO-ART dictionary to the MedDRA version 10.0

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 6, 2018
• Study Start: October 22, 1998
• Primary Completion: February 20, 2001
• Study Completion: February 20, 2001
• Last Updated: August 12, 2019
• Results First Posted: August 12, 2019

Record last verified: 2019-07