Phase 2
N=83
Pegasys® in Patients With Myeloproliferative Diseases
Myeloproliferative Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00452023 ↗Enrolled (actual)
83
Serious AEs
16.9%
Results posted
Dec 2024
Primary outcome: Primary: Number of Patients With Complete Response (CR) or Partial Response (PR) — 3; 3; 14; 23 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IFN-alpha2a (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Complete Response (CR) or Partial Response (PR) |
3; 3; 14; 23; 23 | — |
Summary
The goal of this clinical research study is to see if Pegasys (IFN-alpha2a) can help to control the disease in patients with ET, PV, AMM/MF, and Ph-negative CML. The safety of this treatment will also be studied.
Eligibility Criteria
Inclusion Criteria
- Following diagnoses: --ET: Patients with PLT > 600 x10 9 /l documented in the past 12 months; hyperplasia of marrow megakaryocytes in the absence of identifiable cause of thrombocytosis and in the absence of Ph chromosome. Patients with ET and lower PLT will be eligible if attributable to prior ET therapy. --PV: Patients should have Hb >/= 15g/dl (except if patient is having phlebotomies done) and documented past diagnosis.
- Performance status 3 years.
- Patients with history of ischemic retinopathy.
- Patients with history of severe cardiac disease: NYHA Functional Class III or IV, myocardial infarction within 6 months, uncontrolled ventricular tachyarrhythmias or unstable angina.
- Patients with history of medically significant psychiatric disease if not controlled, especially endogenous depression (does not include reactive depression post-cancer diagnosis), psychosis and bipolar disease.
- Patients with seizure disorders requiring anticonvulsant therapy.
- Patients with known infection with HBV, HIV, or other active systemic infection.
- Patients with known autoimmune disease except for rheumatoid arthritis.
- Patients with renal disease on hemodialysis.
- Patients taking continuous or chronic high-dose systemic steroids; if discontinued, there must be a minimum washout period of one month before study drug is begun.
- Patients with known hypersensitivity to PEG-IFN alpha-2a or its components.
Data sourced from ClinicalTrials.gov (NCT00452023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.