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Chronic Myelogenous LeukemiaPhase 2/3NCT03547154

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

A Phase 2/3 study testing Pegylated interferon alfa-2b and Interferon alfa-2b in people with Chronic Myelogenous Leukemia, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Myelogenous Leukemia
What is being tested?
Pegylated interferon alfa-2b and Interferon alfa-2b
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
344 participants
Where
No sites listed yet
Study dates
22 Oct 1998to 20 Feb 2001
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

About this study

Official title: A RANDOMIZED PHASE 2/3 TRIAL OF SCH 54031 PEG12000 INTERFERON ALFA-2b (PEG INTRON, SCH 54031) VS. INTRON A (SCH 30500) IN SUBJECTS WITH NEWLY DIAGNOSED CML (PROTOCOL NOS. C/I98-026)

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.

Being tested
Pegylated interferon alfa-2b, Interferon alfa-2b
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pegylated interferon alfa-2bBiological

    Also called PEG Intron

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

  • Interferon alfa-2bBiological

    Also called INTRON^® A

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

Study groups in NCT03547154
Study groupRoleWhat they receive
Pegylated interferon alfa-2bExperimentalParticipants 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.
Receives: Biological: Pegylated interferon alfa-2b
Interferon alfa-2bActive comparatorParticipants 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.
Receives: Biological: Interferon alfa-2b

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 12 months

Secondary outcomes (3)

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

    Cytogenetic response (CR) at 6 months, as at 12 months, was defined by the degree of suppression of Philadelphia chromosome (Ph^1) achieved during study treatment. The determination of CR at 6 months was 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 (0%), Partial (1-34%), Minor (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.

    Measured: 6 months

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

    Hematologic response at 6 months was assessed, while the hematologic response was measured at 3, 6, 9 and 12 months during the first year of study treatment. To be considered a hematologic responder a participant must have met all of the following criteria for a minimum of 28 days: WBC count <10,000/μL; platelet count <450,000/L; normal differential count in peripheral blood (manual differential count); no palpable spleen. Participants achieving a complete hematologic response at 3 months had the cytogenetic response evaluated at 3 months as well. Participants who achieved a complete hematologic response by 6 months continued treatment for another 6 months. Participants who failed to achieve a complete hematologic response after 6 months of treatment were considered treatment failures, and further treatment for this group was at the discretion of the treating physician. Participants may have continued to receive their assigned study medication for an additional 6 months.

    Measured: 6 months

  3. Number of Participants With Overall Survival

    Participants were followed for survival; those who did not achieve a major cytogenetic response were discontinued from the study. For participants who completed 1 year of study treatment and continued to Year 2 and beyond, survival and disease progression every 3 months were assessed, and serious adverse events (SAEs) were reported. Participants were followed until resolution of any drug-related nonserious adverse event, and any SAE occurring while on the study or within 30 days of last dose of study drug. Participant death during survival follow-up was reported to the drug safety unit of the Sponsor. Each participant (whether discontinued or still on treatment) was followed every 3 months for survival and disease progression information. Overall survival was analyzed using the log-rank statistic, and the hazard ratio (HR) and 95% confidence interval (CI) for the HR were obtained using Cox's proportional hazards model.

    Measured: Up to 2 years (24 months), and beyond

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2018
  2. Study start22 Oct 1998
  3. Primary completion20 Feb 2001
  4. Study completion20 Feb 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
344 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03547154
Sponsor's protocol ID
C98026
Other IDs
MK-4031-001, C98-026
Status last verified
Jul 2019
First submitted
24 May 2018
Last updated
12 Aug 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Pegylated interferon alfa-2b and Interferon alfa-2b in people with Chronic Myelogenous Leukemia, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03547154.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019; AzTrials last refreshed its copy on 1 Nov 2026.

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