Curcumin to Improve Inflammation and Symptoms in Patients With Clonal Cytopenia of Undetermined Significance, Low Risk Myelodysplastic Syndrome, and Myeloproliferative Neoplasms

NCT06063486 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 9L-23-1NCI-2023-06976P30CA014089
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Essential Thrombocythemia; Myelodysplastic Syndrome; Myelofibrosis; Polycythemia Vera; Clonal Cytopenia of Undetermined Significance

Outcome Measures

Primary Outcomes (3)

• Mean change in peripheral blood levels of inflammatory cytokines

  Interleukin (IL) 1beta, IL-6, IL-18, transforming growth factor-beta, and tumor necrosis factor-alpha will be assessed. Mean inflammatory cytokine changes in the treatment group will be compared to that of the control group. A two-sided two-sample unequal-variance t-test will be applied to compare the difference of the mean of changes at 12-months from the baseline measurement between the two arms, respectively. P-values from the test and the 95% confidence interval of the estimated difference will be reported for each of the inflammatory cytokines.

  At baseline, 3 months, and 12 months

• Mean change in symptom scores for clonal cytopenia of undetermined significance and low risk myelodysplastic syndrome patients

  Symptoms scores will be assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 version 3 (EORTC-QLQ-C30 version 3).This is a validated tool for assessing health-related quality of life in cancer patients. The questionnaire is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. Scores range from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems.(no symptom) to 10 (worst possible symptom).

  At baseline, 3 months, 12 months

• Mean change in symptom scores for myeloproliferative neoplasm (MPN) patients

  MPN-related symptoms will be assessed using the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score. Possible scores range from 0 (no symptom) to 10 (worst possible symptom).

  At baseline, 3 months, 12 months

Secondary Outcomes (5)

• Change in the variant allele frequency of mutated clones

  After 12 months of treatment

• Change in the deoxyribonucleic acid methylation pattern

  After 12 months of treatment

• Change in peripheral blood cell counts

  After 12 months of treatment

• Safety of curcumin in patients with CCUS/LR-MDS and symptomatic MPN

  Every 2 weeks for the first month of treatment, every month for the following 2 months, then every 3 months for a total of 12 months.

• Change in the rate of transfusion requirement measured

  Up to 10 years

Study Arms (2)

Arm I (C3 Complex/Bioperine)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Dietary Supplement: Curcumin/ Demethoxycurcumin/Bisdemethoxycurcumin-containing Supplement; Dietary Supplement: Piperine Extract (Standardized); Other: Questionnaire Administration

Arm II (placebo)

PLACEBO COMPARATOR

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.

Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Drug: Placebo Administration; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (C3 Complex/Bioperine); Arm II (placebo)

Bone Marrow Biopsy PROCEDURE

Undergo bone marrow biopsy

Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow

Arm I (C3 Complex/Bioperine); Arm II (placebo)

Piperine Extract (Standardized) DIETARY_SUPPLEMENT

Given PO

Also known as: Bioperine, Standardized Piperine Extract

Arm I (C3 Complex/Bioperine)

Placebo Administration DRUG

Given PO

Also known as: Sugar pills

Arm II (placebo)

Questionnaire Administration OTHER

Ancillary studies

Arm I (C3 Complex/Bioperine); Arm II (placebo)

Bone Marrow Aspiration PROCEDURE

Undergo bone marrow aspiration

Arm I (C3 Complex/Bioperine); Arm II (placebo)

Curcumin/ Demethoxycurcumin/Bisdemethoxycurcumin-containing Supplement DIETARY_SUPPLEMENT

Given PO

Also known as: Curcumin C3 Complex

Arm I (C3 Complex/Bioperine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

RECRUITING

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

MeSH Terms

Conditions

Thrombocythemia, Essential; Myelodysplastic Syndromes; Primary Myelofibrosis; Polycythemia Vera

Interventions

Specimen Handling; Biopsy; Curcumin; demethoxycurcumin; piperine

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombocytosis; Blood Platelet Disorders; Myeloproliferative Disorders; Bone Marrow Diseases; Hemorrhagic Disorders; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Casey L O'Connell, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Duran

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2023
• First Posted: October 2, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (2)