Actively Recruiting
Allogeneic Hematopoietic Cell Transplantation With Pegylated Interferon Alfa-2a for Primary and Secondary Myelofibrosis
Led by University of Utah · Updated on 2025-05-07
18
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single site, open-label, dose de-escalation, Phase 1 study of pegylated interferon alfa-2a administered after alloHCT in subjects with primary or secondary myelofibrosis. Part 1 of the study will assess the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period and identify the Recommended Phase 2 Dose (RP2D). Once the RP2D is identified, 6 additional patients will be enrolled in the expansion cohort.
CONDITIONS
Official Title
Allogeneic Hematopoietic Cell Transplantation With Pegylated Interferon Alfa-2a for Primary and Secondary Myelofibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Diagnosis of primary or secondary myelofibrosis
- Eligible for myeloablative or reduced intensity conditioning regimen before transplant
- Eligible for standard bone marrow biopsy as part of pre-transplant work-up
- Peripheral blood stem cell graft with 10/10 HLA matched related or unrelated donor
- ECOG performance status of 2 or less
- For females: Negative pregnancy test or post-menopausal status as defined by specific hormonal or surgical criteria
- Agreement to use highly effective contraception if of childbearing potential
- Underwent conditioning regimen and are 50 to 80 days post-transplant at therapy start
- Adequate liver and kidney function as defined
- Recovery to baseline or Grade 1 or less CTCAE v5.0 from prior cancer therapy toxicities
- Able to provide informed consent and willing to sign consent form
You will not qualify if you...
- Receiving other investigational agents concurrently
- Prior systemic anti-cancer or investigational therapy within five half-lives before study treatment
- Radiotherapy within 6 weeks before starting study treatment
- Recent major surgery within 6 weeks or not fully recovered from surgery
- Diagnosis of another malignancy within 2 years except certain low-risk cancers
- Active graft-versus-host disease
- Significant uncontrolled cardiovascular conditions or events within 3 months
- QTc prolongation or congenital long QT syndrome
- Left ventricular ejection fraction less than 55%
- Uncontrolled hypertension (≥140/90)
- Any condition contraindicating participation due to safety or compliance concerns
- Active infections including HIV, tuberculosis, or hepatitis C
- Autoimmune hepatitis or decompensated liver disease
- Medical, psychiatric, or cognitive conditions compromising consent or compliance
- Severe hypersensitivity to study drug or components
- Use of prohibited medications without adequate washout
- History of neuropsychiatric, autoimmune diseases, or pancreatitis
- Active interstitial lung disease, pneumonitis, pulmonary hypertension, severe colitis, or certain eye disorders
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
C
Catherine Cromar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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