BridgeMD
New treatment option for Myelofibrosis
Official title AlloHCT With PegINFa for Myelofibrosis
ClinicalTrials.gov ID: NCT05535764
What this study is testing
What is Pegylated interferon alpha2a?
Pegylated interferon alpha2a is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for myelofibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pre-Transplant (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.
You likely can't join 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...
See the full eligibility criteria
Who can join
- Pre-Transplant (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 people: 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...
- 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 people of childbearing potential and male people 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 (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
- ECOG Performance Status ≤ 2.
- Adequate organ function as defined as:
- Hepatic:
- Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN
- Renal: ---Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula:
- TSH and T4 within normal limits or adequately controlled thyroid function.
- For female people: 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...
- 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 people of childbearing potential and male people with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.1.
- Male people must agree to use a condom during intercourse for the duration of study therapy as described in Section 5.4.1.
- Recovery to baseline or ≤ Grade 1 CTCAE v5.0 from toxicities related to any prior cancer therapy, unless considered clinically not significant by the treating investigator.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
What rules you out
- 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...
- 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...
- 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: people...
- 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).
- people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Salt Lake City, Utah, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.