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Clonal Cytopenia of Undetermined SignificancePhase 2NCT06063486

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

A Phase 2 study testing Biospecimen Collection, Bone Marrow Aspiration and Bone Marrow Biopsy in people with Clonal Cytopenia of Undetermined Significance and Essential Thrombocythemia, run by University of Southern California at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Bone Marrow Aspiration and Bone Marrow Biopsy
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
2 sitesUnited States
Study dates
1 Mar 2024to 1 Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Christine Duran contact

323-865-0371

duran_c@med.usc.edu

United States2 sites, 2 recruiting

  • Los Angeles General Medical Center

    Los Angeles, California, 90033

    Christine Duran, 323-865-0371, duran_c@med.usc.edu

    Casey L. O'Connell, MD

    Recruiting

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Christine Duran, 323-865-0371, duran_c@med.usc.edu

    Casey L. O'Connell, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2, Double-blind, Randomized Study to Compare the Effect of Curcumin Versus Placebo on Inflammatory Cytokines, Symptoms and Disease Parameters in Clonal Cytopenia of Undetermined Significance (CCUS), Low-Risk Myelodysplastic Syndrome (LR-MDS), and Myeloproliferative Neoplasms (MPNs)

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To compare the change in inflammatory cytokine levels in study patients treated with curcumin versus placebo over a 12-month follow-up period.

II. To compare the change in symptomatology in study patients treated with curcumin versus placebo over a 12-month follow-up period.

SECONDARY OBJECTIVES:

  1. To investigate the effect on variant allele frequency (VAF) of baseline mutations in study patients treated with curcumin versus placebo.

II. To investigate the effect on methylation patterns in study patients treated with curcumin versus placebo.

III. To evaluate the effect on peripheral blood cells in study patients treated with curcumin versus placebo.

IV. To assess the safety of curcumin for patients with CCUS/LR-MDS and symptomatic MPN who do not require disease-modifying therapy.

EXPLORATORY OBJECTIVE:

  1. To investigate the correlation between inflammatory cytokine levels and symptom scores in study patients treated with curcumin versus placebo.

OUTLINE: Patients are randomized to 1 of 2 arms.

Arm I: Patients receive curcumin/demethoxycurcumin/bisdemethoxycurcumin-containing supplement (C3 complex)/piperine extract (standardized) (Bioperine) orally (PO) twice daily (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.

Arm II: 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.

After completion of study treatment, patients are followed up annually for up to 10 years.

Being tested
Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Curcumin/ Demethoxycurcumin/Bisdemethoxycurcumin-containing Supplement, Piperine Extract (Standardized)
Medical subject headings
Thrombocythemia, Essential, Myelodysplastic Syndromes, Primary Myelofibrosis, Polycythemia Vera

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood samples

  • Bone Marrow AspirationProcedure or surgery

    Undergo bone marrow aspiration

  • Bone Marrow BiopsyProcedure or surgery

    Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow

    Undergo bone marrow biopsy

  • Curcumin/ Demethoxycurcumin/Bisdemethoxycurcumin-containing SupplementDietary supplement

    Also called Curcumin C3 Complex

    Given PO

  • Piperine Extract (Standardized)Dietary supplement

    Also called Bioperine, Standardized Piperine Extract

    Given PO

  • Placebo AdministrationDrug

    Also called Sugar pills

    Given PO

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT06063486
Study groupRoleWhat they receive
Arm I (C3 Complex/Bioperine)ExperimentalPatients 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.
Receives: 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 comparatorPatients 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.
Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Drug: Placebo Administration; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At baseline, 3 months, and 12 months

  2. 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).

    Measured: At baseline, 3 months, 12 months

  3. 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).

    Measured: At baseline, 3 months, 12 months

Secondary outcomes (5)

  1. Change in the variant allele frequency of mutated clones

    Both parametric methods i.e., the two-sample t-test and the non-parametric Wilcoxon rank sum test (with no assumption on the distribution of the data) will be applied.

    Measured: After 12 months of treatment

  2. Change in the deoxyribonucleic acid methylation pattern

    Both parametric methods i.e., the two-sample t-test and the non-parametric Wilcoxon rank sum test (with no assumption on the distribution of the data) will be applied.

    Measured: After 12 months of treatment

  3. Change in peripheral blood cell counts

    Peripheral blood cell counts will include absolute neutrophil count, hemoglobin, and platelets. Change in peripheral blood cell counts will be compared to pretreatment. Both parametric methods i.e., the two-sample t-test and the non-parametric Wilcoxon rank sum test (with no assumption on the distribution of the data) will be applied.

    Measured: After 12 months of treatment

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

    Will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.

    Measured: 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.

  5. Change in the rate of transfusion requirement measured

    Will be measured by the number of units required per 8-week period. Both parametric methods i.e., the two-sample t-test and the non-parametric Wilcoxon rank sum test (with no assumption on the distribution of the data) will be applied.

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2023
  2. Study start1 Mar 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06063486
Sponsor's protocol ID
9L-23-1
Other IDs
NCI-2023-06976, 9L-23-1, P30CA014089
Status last verified
Mar 2026
First submitted
23 Sep 2023
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Bone Marrow Aspiration and Bone Marrow Biopsy in people with Clonal Cytopenia of Undetermined Significance and Essential Thrombocythemia, run by University of Southern California at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christine Duran (323-865-0371, duran_c@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in peripheral blood levels of inflammatory cytokines (time frame: At baseline, 3 months, and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06063486.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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