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Curcumin Supplement for Myelodysplastic Syndrome and Myeloproliferative Disorders

Phase 2

Recruiting

Led By Casey L O'Connell, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

LR-MDS as defined by WHO 2016 diagnosis criteria

A diagnosis of CCUS or LR-MDS

Must not have

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)

Patients with intermediate or high-risk MDS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Summary

This trial looks at how a curcumin supplement can reduce inflammation and symptoms in patients with CCUS, LR-MDS, and MPN. Curcumin has anti-inflammatory and anti-cancer properties and has been studied for various diseases.

Who is the study for?

Adults over 18 with certain blood disorders like polycythemia, thrombocytosis, or myelofibrosis who are stable and not likely to need new treatments soon. Also for those with clonal cytopenia or low-risk myelodysplastic syndrome, experiencing symptoms like fatigue. Not for pregnant/nursing individuals, those on steroids/anti-inflammatories, or taking curcumin supplements.

What is being tested?

This phase II trial tests if a curcumin supplement (with anti-inflammatory properties) can reduce inflammation and improve symptoms in patients with specific pre-leukemia conditions and other related blood disorders.

What are the potential side effects?

While the trial description does not specify side effects of curcumin, generally it may cause digestive upset, headache, rash or yellow stool; high doses could lead to more serious issues such as ulcers or liver problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition is low-risk myelodysplastic syndrome.

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I have been diagnosed with CCUS or low-risk MDS.

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I have low blood counts for over 6 months, no genetic abnormalities, and specific mutations but no clear cancer diagnosis from bone marrow tests.

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I have been diagnosed with PV, ET, or MF according to WHO criteria.

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I have a symptom from my condition that is quite bothersome.

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My fatigue level is high, scoring at least 25 on a symptom questionnaire.

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I am 18 years old or older.

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I can perform daily activities with minimal assistance.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking steroids, high-dose anti-inflammatories, or herbal anti-inflammatories.

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My condition is classified as intermediate or high-risk MDS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean change in peripheral blood levels of inflammatory cytokines

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

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

Secondary study objectives

Change in peripheral blood cell counts

Change in the deoxyribonucleic acid methylation pattern

Change in the rate of transfusion requirement measured

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (C3 Complex/Bioperine)Experimental Treatment6 Interventions

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.

Group II: Arm II (placebo)Placebo Group5 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Piperine Extract (Standardized)

2016

Completed Phase 1

~10

Bone Marrow Biopsy

2021

Completed Phase 3

~230