AlloHCT With PegINFa for Myelofibrosis
Recruiting now · Phase 1
Conditions studied: Myelofibrosis
In brief
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.
Key facts
- Study ID
- NCT05535764
- Run by
- University of Utah
- People needed
- 18
- Starts
- 2023-08-02
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2026-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Pre-Transplant Inclusion Criteria (Step 1)
- Male or female subject aged ≥ 18 years.
- Diagnosis of primary or secondary myelofibrosis.
- Eligible to undergo a myeloablative or reduced intensity conditioning regimen (MAC or RIC)
- Eligible to undergo a standard of care bone marrow biopsy with aspirate as part of his or her routine pre-transplant work-up.
- Peripheral blood stem cell (PBSC) graft
- 10/10 HLA matched related or matched unrelated donor
- ECOG performance status ≤ 2.
- For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- Women < 50 years of age:
- Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
- Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or
- Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- Women ≥ 50 years of age:
- Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
- Had radiation-induced menopause with last menses >1 year ago; or
- Had chemotherapy-induced menopause with last menses >1 year ago; or
- Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
- Female subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.1.
- Treatment Inclusion Criteria (Step 2)
- Male or female subject aged ≥ 18 years.
- Diagnosis of primary or secondary myelofibrosis.
- Have undergone a myeloablative or reduced-intensity conditioning regimen (MAC or RIC) and be 50-80 days from Day 0 of transplant at initiation of study therapy.
- Peripheral blood stem cell (PBSC) graft
- 10/10 HLA matched related or matched unrelated donor
You may not qualify if…
- Exclusion Criteria (Step 2)
- Receiving other investigational agents concurrently
- Prior systemic anti-cancer therapy or any investigational therapy within five half-lives prior to starting study treatment.
- Prior radiotherapy within 6 weeks prior to the first dose of study treatment.
- Major surgery within 6 weeks prior to starting study drug or patients who have not fully recovered from major surgery.
- The diagnosis of another malignancy within ≤ 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix, or low-grade prostate cancer with Gleason Score ≤ 6).
- Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
- Graft-versus-host disease:
- --Acute or chronic
- Cardiovascular disorders:
- Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.
- Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 3 months before the first dose.
- QTc prolongation defined as a QTcF > 500 ms.
- Known congenital long QT.
- Left ventricular ejection fraction < 55%.
- Uncontrolled hypertension defined as ≥ 140/90 as assessed from the mean of three consecutive blood pressure measurements taken over 10 minutes.
- Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, [subjects may not receive the drug through a feeding tube], social/ psychological issues, etc.)
- Active infection including HIV, tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice) or hepatitis C.
- -Note: Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible.
- Autoimmune hepatitis or decompensated hepatic disease
- Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.
- Known prior severe hypersensitivity to investigational product (IP) or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).
- Subjects taking prohibited medications as described in Section 6.5.1. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.
- History of neuropsychiatric disease, autoimmune disease, or pancreatitis.
- Presence of active interstitial lung disease or pneumonitis, bronchiolitis obliterans, pulmonary hypertension, ulcerative and hemorrhagic/ischemic colitis, and ophthalmologic disorders.
Where it is running
- Huntsman Cancer Institute at the University of Utah — Salt Lake City, Utah, United States (enrolling)
Full record on ClinicalTrials.gov
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