Is NCT05233618 recruiting in Charlottesville, VA?

Yes, NCT05233618 is currently recruiting participants at its Charlottesville, VA location. This myelofibrosis clinical trial is actively enrolling qualified participants.

How do I join the myelofibrosis clinical trial in Charlottesville?

To join this clinical trial in Charlottesville, 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 Charlottesville 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 Charlottesville, VA

About This Myelofibrosis Study in Charlottesville

In this study, tagraxofusp (Tag) is given to patients with CD 123+ myelofibrosis (MF), chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia (AML) after allogeneic stem cell transplant (HCT) to help prevent relapse. Patients will receive up to about 9 cycles of treatment with Tag and have a bone marrow biopsy after cycle 4 and about 1 year after HCT.

Sponsor: Karen Ballen, MD

Who Can Participate

Inclusion Criteria

The patient is ≥18 years old and ≤ 75 years old.

The patient has a life expectancy of \>6 months.

The patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.

The patient has adequate baseline organ function, including cardiac, renal, and hepatic function within 28 days of start of therapy:

Left ventricular ejection fraction (LVEF) ≥ 50% as measured by multigated acquisition scan (MUGA) or 2-dimensional (2-D) echocardiogram (ECHO) and no clinically significant abnormalities on a 12-lead electrocardiogram (ECG)

Serum Creatinine ≤ 1.5 mg/dL

Bilirubin ≤1.5 mg/dL

Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN)

Absolute neutrophil count (ANC) ≥0.5 × 10⁹/L

Platelets ≥ 80,000/mm\^3

Serum albumin ≥3.2 (note that albumin infusions are not permitted in order to enable eligibility)

Patient meets the 2016 WHO diagnostic criteria for MF, is CD 123+, and has an IPSS/DIPSS/DIPSS-plus intermediate-1 with anemia (Hb \< 10g/dl), splenomegaly (\> 12 cm), leukocytosis (WBC \> 25K) intermediate-2 or high-risk disease pre transplant. Or Patient has a 2016 WHO-defined diagnosis of CMML (persistent monocytosis ≥1 × 10⁹/L for at least 3 months, with other causes excluded, and monocytes ≥10% of WBC in peripheral blood, no criteria and no previous history of CML, ET, PV, and acute promyelocytic leukemia) pre transplant and is CD123+ Or Patient has 2016 WHO-defined CMML-1 (2-4% blasts in peripheral blood and/or 5-9% blasts in bone marrow) and CMML-2 (5-19% blasts in peripheral blood and/or 10-19% blasts in bone marrow, and/or presence of Auer rods) pre transplant and is CD 123+ Or Patient has CD 123+ AML in morphologic remission pre transplant Or Patient has Intermediate or high risk MDS by IPSS-R or moderate or high risk by IPSS-M pre transplant and has had no morphologic progression of disease post-transplant. Receipt of first allogeneic stem cell transplant (related, unrelated, haploidentical or cord blood) 60-120 days prior to study registration

Patient is in morphologic remission according to bone marrow biopsy completed within 30 days prior to planned start of study treatment

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

For females and males of reproductive potential: agreement to use adequate contraception for at least one month prior to screening, during study participation and for an additional one week after the end of study drug administration. Other (non-study) medications may require participants to use adequate contraception for longer.

For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner. Other (non-study) medications may require participants to use adequate contraception for longer.

Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria

Treatment with any disease-related therapy, including radiation therapy or investigational agent, within 14 days of study entry

Previous treatment with tagraxofusp or known hypersensitivity to any components of the drug product

Active malignancy and/or cancer history (excluding myeloproliferative disorders and concomitant myeloid malignancies as specified in the inclusion criteria) that can confound the assessment of the study endpoints. Patients with a past cancer history (within 2 years of entry) and/or ongoing active malignancy or substantial potential for recurrence must be discussed with the Sponsor before study entry. Patients with the following neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including superficial bladder cancer), cervical intraepithelial neoplasia, or organ-confined prostate cancer with no evidence of progressive disease.

Known active or suspected disease involvement of the central nervous system (CNS)

Receiving \> 10 mg prednisone daily for GVHD

Overall Grade 2 or greater acute GVHD (per Magic criteria) at time of registration

Pregnant or breast feeding

Requirement of supplemental oxygen

Clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction or stroke within 6 months of study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication)

Uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator would put the patient at significant risk for pulmonary complications during the study

Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study requirements

Known positive status for human immunodeficiency virus or active or chronic Hepatitis B or Hepatitis C

Receiving treatment for known or suspected fungal infection (prophylaxis is acceptable)

Known positive SARS-COV-2 test within 3 weeks of study entry. Exception: Tests that reflect past, resolved infection where the patient is determined to NOT be infectious, according to an infectious disease specialist, do not exclude the patient from participation.

Pedal edema ≥ grade 2

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 Charlottesville?

Yes, this clinical trial (NCT05233618) has an active research site in Charlottesville, VA 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 Charlottesville, VA

If you're searching for myelofibrosis treatment options in Charlottesville, VA, this clinical trial (NCT05233618) 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 Charlottesville research site is actively enrolling participants for this 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 Charlottesville, VA

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