Clinical trial · Interventional
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 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)
NCT03547154CI-TRIAL-00040002terminatedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interferon alfa-2b | Biological | Interferon Alfa-2b | ALIAS |
| Pegylated interferon alfa-2b | Biological | Peginterferon Alfa-2b | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pegylated interferon alfa-2b
- description
- 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.
- interventionNames
- Biological: Pegylated interferon alfa-2b
- type
- ACTIVE_COMPARATOR
- label
- Interferon alfa-2b
- description
- 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.
- interventionNames
- Biological: Interferon alfa-2b
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.