Recruiting
Phase 2

Curcumin

Sponsor:

University of Southern California

Code:

NCT06063486

Conditions

Clonal Cytopenia of Undetermined Significance

Essential Thrombocythemia

Myelodysplastic Syndrome

Myelofibrosis

Polycythemia Vera

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Bone Marrow Aspiration

Bone Marrow Biopsy

Curcumin/ Demethoxycurcumin/Bisdemethoxycurcumin-containing Supplement

Piperine Extract (Standardized)

Study Details

Brief summary:

This phase II trial evaluates how a curcumin supplement (C3 complex/Bioperine) changes the inflammatory response and symptomatology in patients with clonal cytopenia of undetermined significance (CCUS), low risk myelodysplastic syndrome (LR-MDS), and myeloproliferative neoplasms (MPN). Chronic inflammation drives disease development and contributes to symptoms experienced by patients with CCUS, LR-MDS, and MPN. Curcumin has been shown to have anti-inflammatory and anti-cancer properties and has been studied in various chronic illnesses and hematologic diseases.

Conditions

Clonal Cytopenia of Undetermined Significance

Essential Thrombocythemia

Myelodysplastic Syndrome

Myelofibrosis

Polycythemia Vera

Study ID

NCT06063486

Start date

Mar 1, 2024

Status verified date

Mar, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age >= 18
  • Eastern Cooperative Oncology Group (ECOG) =< 2
  • Ability to understand and willingness to sign a written informed consent
  • Diagnosis of polycythemia vera (PV), essential thrombocytosis (ET) or myelofibrosis (MF) per World Health Organization (WHO) 2016 diagnostic criteria

  • Presence of at least one symptom measurable using the MPN-/Symptom Assessment Form (SAF) with a severity greater than 3
  • MPN patients determined to have stable disease undergoing surveillance and unlikely to require initiation of new cytoreductive therapy (i.e., hydroxyurea, ruxotinib, interferon within the study period); patients on a stable dose of hydroxyurea for at least 6 months who meet the other inclusion/exclusion criteria may be included
  • A diagnosis of CCUS or LR-MDS

  • CCUS defined as persistent cytopenia for > 6 months (hemoglobin \[Hgb\] < 11.3 g/dL \[7 mmol/L\] in women and Hgb < 12.9 g/dL \[8 mmol/L\] in men, platelet < 150 x 10\^9/L or neutrophils < 1.8 x 10\^9/L), normal cytogenetics, presence of detectable MDS associated mutations and bone marrow morphology non-diagnostic of MDS or any other malignancies
  • LR-MDS as defined by WHO 2016 diagnosis criteria
  • Minimum baseline symptom score of 25 in the fatigue section of the symptom questionnaire

Exclusion Criteria:

  • Patients with intake of curcumin as a dietary supplement, including multivitamin and unwillingness to quit more than 24 hours before study start
  • Patients with inability to understand and adhere to information given
  • Patients receiving active treatment for another malignancy except with hormonal therapy for a malignancy considered to be in remission or growth factors (erythropoietin, granulocyte colony-stimulating factor \[G-CSF\] and luspatercept)
  • Patients with intermediate or high-risk MDS
  • Patients must not be pregnant or nursing
  • Patients must not be on any oral or intravenous steroid or any other anti-inflammatories (ibuprofen > 200mg/week or 400mg/month, naproxen of any dose, > 325mg aspirin daily, any herbal anti-inflammatory concoction of any dose)

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm I (C3 Complex/Bioperine)

Patients receive C3 complex/Bioperine PO BID for 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy at baseline and follow up, and collection of blood samples throughout the trial.

placebo comparator: Arm II (placebo)

Patients receive placebo PO BID for 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy at baseline and follow up, and collection of blood samples throughout the trial.

Interventions

Biospecimen Collection

Undergo collection of blood samples

Bone Marrow Aspiration

Undergo bone marrow aspiration

Bone Marrow Biopsy

Undergo bone marrow biopsy

Curcumin/ Demethoxycurcumin/Bisdemethoxycurcumin-containing Supplement

Given PO

Piperine Extract (Standardized)

Given PO

Placebo Administration

Given PO

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Mean change in peripheral blood levels of inflammatory cytokines [ Time Frame: At baseline, 3 months, and 12 months ]
  • Mean change in symptom scores for clonal cytopenia of undetermined significance and low risk myelodysplastic syndrome patients [ Time Frame: At baseline, 3 months, 12 months ]
  • Mean change in symptom scores for myeloproliferative neoplasm (MPN) patients [ Time Frame: At baseline, 3 months, 12 months ]

Central Contacts and Locations

Central contacts

Christine Duran

323-865-0371duran_c@med.usc.edu

Locations

Los Angeles General Medical Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Christine Duran

323-865-0371duran_c@med.usc.edu

Principal Investigator:

Casey L. O'Connell, MD

USC / Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Christine Duran

323-865-0371duran_c@med.usc.edu

Principal Investigator:

Casey L. O'Connell, MD

More Information

Sponsor

University of Southern California

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-03-27.