Is NCT05320198 recruiting in Irvine, CA?

Yes, NCT05320198 is currently recruiting participants at its Irvine, CA location. This myelofibrosis clinical trial is actively enrolling qualified participants.

How do I join the myelofibrosis clinical trial in Irvine?

To join this clinical trial in Irvine, 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 Irvine 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 Irvine, CA

Who Can Participate

Inclusion Criteria

for Participants with MF and Anemia: Participants are eligible for the study if all of the following criteria apply:

Age 18 years or older at the time of signing the informed consent form (ICF).

For Phase 1b: Dynamic International Prognostic Scoring System (DIPSS) score of 3 to 4 (intermediate 2 risk) or ≥5 (high-risk) primary MF, post PV MF, and/or post ET MF, as confirmed in the most recent local bone marrow biopsy report, according to World Health Organization (WHO) 2016 criteria. For Phase 2: In addition to the criteria above, DIPSS score of ≥2 (intermediate 1 risk) may also be included.

Washout of at least 28 days prior to Screening of the following treatments:

Immunomodulators (lenalidomide, thalidomide)

Luspatercept/sotatercept

Systemic corticosteroids are permitted for non-hematological conditions if stable or decreasing dose for ≥28 days prior to Screening and receiving an equivalent to ≤10 mg prednisone for the 28 days immediately prior to Screening. Screening can begin before the 28 day washout is completed, but the washout period must be completed prior to collection of Screening blood samples.

Anemia: For Phase 1b: Hgb \<10 g/dL on ≥3 assessments over 84 days prior to Screening, without RBC transfusion, or Hgb \<10 g/dL and receiving RBC transfusions periodically but not meeting criteria for TD participant as defined for the TD cohort. The baseline Hgb value for these participants is the lowest Hgb level during the 84 days prior to Screening, or RBC transfusion dependence, defined as an RBC transfusion frequency of ≥6 units PRBC over the 84 days immediately prior to Screening. There must not be any consecutive 42-day period without an RBC transfusion in the 84-day period, and the last transfusion must be within 28 days prior to Screening. For Phase 2: TD high transfusion burden cohort: RBC transfusion dependence, defined as an RBC transfusion requirement of 3 to 12 PRBC units over the 84 days immediately prior to Screening TD low transfusion burden cohort: RBC transfusion dependence, defined as an RBC transfusion requirement of 1 to 2 PRBC units over the 84 days immediately prior to Screening nTD Cohort: Non-transfusion dependence, baseline Hgb \<10 g/dL as defined on ≥3 assessments over 84 days prior to Screening, without RBC transfusion

Stable dosing of MF-directed therapy:

Hydroxyurea, or, if taking any other treatment for MF, stable for at least 28 days prior to Screening.

Interferon alpha stable dosing for at least 12 weeks prior to Screening.

JAK inhibitors require 12 weeks of stable dosing prior to Screening. For the TD high, TD low, and nTD cohorts, JAK inhibitors allowed include momelotinib, pacritinib, fedratinib, and ruxolitinib.

If the participant discontinues JAK inhibitor (including momelotinib/pacritinib/ruxolitinib/fedratinib) and/or hydroxyurea prior to Screening, a 60-day washout period is required.

Eastern Cooperative Oncology Group (ECOG) performance score ≤2.

Infusion of hematopoietic stem cell transplant not anticipated within 8 months after Screening.

TSAT \<75% (local lab acceptable) at or within 2 weeks of Screening.

Liver iron concentration by MRI \<7 mg/g dry weight within 3 months of eligibility confirmation by central review. Required for TD high participants only.

Serum ferritin ≥50 µg/L at Screening.

Platelet count ≥25,000/µL and \<1,000,000/µL; neutrophils ≥1,000/µL; and total white blood cell (WBC) count \<50,000/µL at Screening.

Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula.

Aspartate aminotransferase (AST) and ALT \<3.0x upper limit of normal (ULN) at Screening.

Direct bilirubin \<2x ULN at Screening. Higher levels are acceptable if these can be attributed by the Investigator to ineffective erythropoiesis or Gilbert's syndrome, with approval from Sponsor.

If male with female sexual partner(s) of childbearing potential, agrees to use 1 of the following highly effective methods of contraception during the study and for at least 8 weeks after the last study drug dose:

Stable hormonal contraceptive (≥3 months; female partner)

Intrauterine device in place for at least 3 months (female partner)

Surgically sterile hysterectomy, bilateral oophorectomy, or bilateral tubal ligation (female partner)

Confirmed successful vasectomy

If female, then EITHER postmenopausal (defined as 12 months of spontaneous amenorrhea, 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels \>40 mIU/ml, or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy), surgically sterile, OR agreeable to use 1 of the following highly effective contraception methods (listed below) on Day 1 (or earlier) and for at least 8 weeks after the last dose of study drug:

Stable hormonal contraceptive (≥3 months)

Intrauterine device in place for at least 3 months

Tubal ligation or single male partner with vasectomy

Negative urine pregnancy test (females of childbearing potential) at Screening (Days 28 to 2).

Able to understand the study aims, procedures, and requirements, and provide written informed consent.

Able to comply with all study procedures. Inclusion Criteria for Exploratory Cohort of Participants with MDS and Anemia: Participants are eligible for the MDS exploratory cohort if all of the following criteria apply:

Age 18 years or older at the time of signing the ICF.

Molecular International Prognostic Scoring System (IPSS-M) classification of very low, low, or intermediate (ie, lower risk) MDS-ringed sideroblasts (RS) negative, MDS/MPN with ringed sideroblasts and thrombocytosis (RS-T), Chronic Myelomonocytic Leukemia (CMML), Atypical Chronic Myeloid Leukemia (aCML), or Myelodysplastic/Myeloproliferative Neoplasms, Unclassifiable (MDS/MPN-U) as confirmed in the most recent local bone marrow biopsy report according to WHO criteria.

Washout of at least 28 days is required for prior anemia/neutropenia-directed therapies, including:

EPO-stimulating agents

Luspatercept

Sotatercept (ACE-011)

Granulocyte colony-stimulating factor (G CSF) OR granulocyte-macrophage CSF (GM CSF).

Systemic corticosteroids (except for participants on a stable or decreasing dose for ≥28 days prior to randomization for non-hematological conditions and receiving an equivalent to ≤10 mg prednisone for the 28 days immediately prior to Screening) Screening can begin before the 28-day washout is completed, but the washout period must be completed prior to collection of Screening blood samples.

Baseline Hgb of \<10 g/dL on ≥3 assessments over 84 days prior to Screening, without RBC transfusion, or Hgb \<10 g/dL and receiving RBC transfusions periodically during the 84 days prior to Screening

Medical history of ≤24 units of PRBC for MDS and anemia

ECOG performance score ≤2

Infusion of hematopoietic stem cell transplant not anticipated within 8 months after Screening

TSAT \<75% (local lab acceptable) at or within 2 weeks of Screening

Liver iron concentration by MRI \<7 mg/g dry weight within 3 months of eligibility confirmation by central review

Serum ferritin ≥50 μg/L at Screening

Platelet count ≥25,000/μL and \<1,000,000/μL, and total WBC count \<50,000/μL at Screening or otherwise approved by Sponsor.

eGFR ≥30 mL/min/1.73 m2 by the CKD-EPI formula

AST and ALT \<3x ULN at Screening

Direct bilirubin \<2x ULN at Screening. Higher levels are acceptable if these can be attributed by the Investigator to ineffective erythropoiesis.

Stable hormonal contraceptive (≥3 months; female partner)

Intrauterine device in place for at least 3 months (female partner)

Surgically sterile hysterectomy, bilateral oophorectomy, or bilateral tubal ligation (female partner)

Confirmed successful vasectomy

If female, then EITHER postmenopausal (defined as 12 months of spontaneous amenorrhea, 6 months of spontaneous amenorrhea with serum FSH levels \>40 mIU/ml, or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy), surgically sterile, OR agreeable to use 1 of the following highly effective contraception methods (listed below) on Day 1 (or earlier) and for at least 8 weeks after the last dose of study drug:

Stable hormonal contraceptive (≥3 months)

Intrauterine device in place for at least 3 months

Tubal ligation or single male partner with vasectomy

Negative urine pregnancy test (females of childbearing potential) at Screening (Days 28 to 2).

Able to understand the study aims, procedures, and requirements, and provide written informed consent.

Able to comply with all study procedures.

Exclusion Criteria

for Participants with MF and Anemia: Participants are excluded from the study if any of the following criteria apply: Medical History, Participants with MF and Anemia

Hereditary hemochromatosis

Hemoglobinopathy or intrinsic RBC defect associated with anemia

Total splenectomy

Hematopoietic cell transplant within the past 2 years, or graft vs host disease requiring immunosuppression

Current anemia from iron deficiency, vitamin B12 or folate deficiency, infection, or bleeding

Active immune-mediated hemolytic anemia

Symptomatic bleeding, unrelated to surgery, in a critical area or organ and/or bleeding causing a decrease in Hgb of ≥2 g/dL or leading to transfusion of ≥2 units of RBCs in the 6 months prior to Screening

Major surgery within 8 weeks prior to Screening or incomplete recovery from any previous surgery

Malignancy within the past 3 years, other than primary MF, post ET, or post PV MF. The following history or concurrent conditions are allowed:

basal or squamous cell carcinoma of the skin

carcinoma in situ of the cervix or the breast

histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis \[TNM\] clinical staging system) A history of completed treatment (medical or surgical) of stage 1-2 cancers may be permitted with prior Sponsor agreement

Stroke, deep vein thrombosis, or pulmonary or arterial embolism within 3 months prior to Screening

Known allergic reaction to any study drug excipient

A history of anti-drug antibody formation

Inadequately controlled heart disease (New York Heart Association Classification 3 or 4) and/or known to have left ventricular ejection fraction \<35%

Hepatitis B or C, or human immunodeficiency virus (HIV) with detectable viral load

Uncontrolled fungal, bacterial, or viral infection (ongoing signs/symptoms related to the infection, without improvement despite appropriate treatment) Treatment History, Participants with MF and Anemia

Iron chelation therapy in the 28 days prior to Screening

Change in anticoagulant therapy regimen within 8 weeks prior to Screening Laboratory Exclusions, Participants with MF and Anemia

Peripheral blood myeloblasts ≥10% of WBC differential at most recent evaluation prior to Screening

Positive direct antiglobulin test in conjunction with a reactive RBC eluate at Screening Miscellaneous, Participants with MF and Anemia

Pregnant or lactating

Condition or concomitant medication that would confound the ability to interpret study data

Other medical or psychiatric condition or laboratory finding not specifically noted above that, in the judgment of the Investigator or Sponsor, would put the participant at unacceptable risk or otherwise preclude the participant from participating in the study

Participation in any other clinical protocol or investigational study that involves administration of experimental therapy and/or therapeutic devices within 30 days prior to Screening Exclusion Criteria for Exploratory Cohort of Participants with MDS and Anemia: Participants are excluded from the MDS exploratory cohort if any of the following criteria apply: Medical History, Participants with MDS and Anemia

Secondary MDS, ie, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation from other diseases

Peripheral blasts ≥5%

Current treatment with hypomethylating agent or other acute myeloid leukemia (AML)-like combination chemotherapy or planned use within 6 months after Screening

Prior treatment with \>3 anemia-directed therapies (unless otherwise approved by Sponsor) including:

Luspatercept

Sotatercept (ACE-011)

EPO-stimulating agent

Hereditary hemochromatosis

Hemoglobinopathy or intrinsic RBC defect associated with anemia

Total splenectomy

Hematopoietic cell transplant within the past 10 years

Current anemia from iron deficiency, vitamin B12 or folate deficiency, infection, or bleeding

Active immune-mediated hemolytic anemia

Major surgery within 8 weeks prior to Screening or incomplete recovery from any previous surgery

Malignancy within the past 3 years, other than MDS or MDS/MPN without excess blasts. The following history or concurrent conditions are allowed:

Basal or squamous cell carcinoma of the skin

Carcinoma in situ of the cervix or the breast

Histologic finding of prostate cancer (T1a or T1b using the TNM clinical staging system) A history of completed treatment (medical or surgical) of stage 1-2 cancers may be permitted with prior Sponsor agreement

Stroke, deep vein thrombosis, or pulmonary or arterial embolism within 6 months prior to Screening

Known allergic reaction to any study drug excipient

A history of antidrug antibody formation

Inadequately controlled heart disease (New York Heart Association Classification 3 or 4) and/or known to have left ventricular ejection fraction \<35%

Active hepatitis B or C, or HIV with detectable viral load

Iron chelation therapy in the 28 days prior to Screening

Change in anticoagulant therapy regimen within 8 weeks prior to Screening Laboratory Exclusions, Participants with MDS and Anemia

Positive direct antiglobulin test in conjunction with a reactive RBC eluate at Screening Miscellaneous, Participants with MDS and Anemia

Pregnant or lactating

Condition or concomitant medication that would confound the ability to interpret study data

Participation in any other clinical protocol or investigational study that involves administration of experimental therapy and/or therapeutic devices within 30 days prior to Screening

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 Irvine?

Yes, this clinical trial (NCT05320198) has an active research site in Irvine, CA 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 Irvine, CA

If you're searching for myelofibrosis treatment options in Irvine, CA, this clinical trial (NCT05320198) 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 Irvine research site is actively enrolling participants for this phase 1/2 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 Irvine, CA

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