Is NCT05535764 recruiting in Salt Lake City, UT?

Yes, NCT05535764 is currently recruiting participants at its Salt Lake City, UT location. This myelofibrosis clinical trial is actively enrolling qualified participants.

How do I join the myelofibrosis clinical trial in Salt Lake City?

To join this clinical trial in Salt Lake City, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Salt Lake City clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Myelofibrosis Clinical Trial in Salt Lake City, UT

About This Myelofibrosis Study in Salt Lake City

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.

Sponsor: University of Utah

Who Can Participate

Inclusion Criteria

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

ECOG Performance Status ≤ 2.

Adequate organ function as defined as:

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.

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.

Male subjects 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.

Exclusion Criteria

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Salt Lake City?

Yes, this clinical trial (NCT05535764) has an active research site in Salt Lake City, UT that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Myelofibrosis Treatment Options in Salt Lake City, UT

If you're searching for myelofibrosis treatment options in Salt Lake City, UT, this clinical trial (NCT05535764) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Salt Lake City research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced myelofibrosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all myelofibrosis clinical trials near you to find additional studies recruiting in your area.

Myelofibrosis Clinical Trial in Salt Lake City, UT

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