Curcumin and Cholecalciferol in Treating Patients With Previously Untreated Stage 0-II Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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ClinicalTrials.gov Identifier: NCT02100423 |
Recruitment Status :
Completed
First Posted : April 1, 2014
Last Update Posted : January 18, 2020
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Condition or disease | Intervention/treatment | Phase |
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Contiguous Stage II Small Lymphocytic Lymphoma Noncontiguous Stage II Small Lymphocytic Lymphoma Stage 0 Chronic Lymphocytic Leukemia Stage I Chronic Lymphocytic Leukemia Stage I Small Lymphocytic Lymphoma Stage II Chronic Lymphocytic Leukemia | Drug: curcumin Dietary Supplement: cholecalciferol Other: laboratory biomarker analysis Other: pharmacological study | Phase 2 |
PRIMARY OBJECTIVES:
I. To determine the overall response rate (ORR) based on National Cancer Institute-Working Group (NCI-WG) criteria in chronic lymphocytic leukemia (CLL) or the Cheson criteria in small lymphocytic lymphoma (SLL).
SECONDARY OBJECTIVES:
I. To determine the time to first cytotoxic treatment (TFCT), progression free survival (PFS), and overall survival (OS) using this regimen.
OUTLINE:
Patients receive curcumin orally (PO) daily on days 1-28 and cholecalciferol PO daily on days 8-28 of course 1 and days 1-28 of subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving partial response or better may receive treatment for a total of 2 years.
After completion of study treatment, patients are followed up for 30 days and then every 3-6 months for 2 years.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 35 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of Curcumin and Vitamin D in Previously Untreated Patients With Early Stage Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) |
Actual Study Start Date : | September 26, 2014 |
Actual Primary Completion Date : | April 4, 2018 |
Actual Study Completion Date : | December 13, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment (curcumin, cholecalciferol)
Patients receive curcumin PO daily on days 1-28 and cholecalciferol PO daily on days 8-28 of course 1 and days 1-28 of subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving partial response or better may receive treatment for a total of 2 years.
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Drug: curcumin
Given PO
Other Names:
Dietary Supplement: cholecalciferol Given PO
Other Names:
Other: laboratory biomarker analysis Correlative studies Other: pharmacological study Correlative studies
Other Name: pharmacological studies |
- Overall response rate (biologic response rate + complete response [CR] + partial response [PR]) based on NCI-WG (for CLL) and Cheson criteria (for SLL) [ Time Frame: The time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years ]The point estimate of the overall response rate and biologic response rate along with 95% confidence intervals will be calculated using binomial distribution theory.
- Time to first cytotoxic treatment [ Time Frame: Time from entry onto study until initiation of treatment with cytotoxic agents because of disease progression, assessed up to 2 years ]Kaplan-Meier method and Cox proportional hazard model will be used for the data analysis.
- Progression free survival [ Time Frame: Time from entry onto study until CLL/SLL progression or death from any cause, assessed up to 2 years ]Kaplan-Meier method and Cox proportional hazard model will be used for the data analysis.
- Overall survival [ Time Frame: Up to 2 years ]Kaplan-Meier method and Cox proportional hazard model will be used for the data analysis.
- Duration of response [ Time Frame: Up to 2 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Have a diagnosis of CLL based on peripheral blood flow cytometry and/or bone marrow aspiration and biopsy OR diagnosis of SLL based on lymph node or bone marrow biopsy; patients with SLL need to have measurable disease
- Performance status (Eastern Cooperative Oncology Group [ECOG]) 0-2
- Patients must have not received any prior treatment for CLL or SLL
- Patients must be stage 0-II based on Rai staging system; must have no indication for treatment for SLL per NCI-WG criteria
- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Hemoglobin >= 10 g/dL
- Serum creatinine =< 2.0 g/dL or calculated creatinine clearance (CrCl) >= 60mL/min (Cockcroft-Gault method)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional upper limit of normal (ULN)
- Bilirubin < 2.0 x ULN, unless subject has Gilbert's disease
- Calcium < 10.1 mg/dL (corrected to serum albumin)
- Females will be either postmenopausal for at least 1 year or surgically sterile for at least 3 months OR females of child-bearing potential must have a negative pregnancy test at screening and agree to take appropriate precautions to avoid pregnancy (double barrier method of birth control or abstinence) from screening through 3 months after the last dose of treatment
- Able to comprehend and willing to sign an Informed Consent Form (ICF)
- Subjects must be off any steroids 7 days prior to the initiation of treatment
- Subjects must be off any curcumin, tumeric, or vitamin D supplements for 14 days prior to the initiation of treatment
- Subjects must be able to take oral medications
Exclusion Criteria:
- Presence of malignancy (other than the one treated in this study) which required systemic treatment within the past 3 years
- Any indication to start treatment for CLL based on NCI-WG criteria
- Prior therapy for CLL/SLL
- Subjects who are pregnant or breast-feeding; breastfeeding should be discontinued if the mother is treated with curcumin
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Concurrent medical condition which may increase the risk of toxicity, including:
- Hypercalcemia of any cause
- Untreated hyperparathyroidism
- Paget's disease of bone
- Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements as judged by treating physician; subjects receiving antibiotics that are under control may be included in the study
- Inability to take oral medications
- Patients receiving other investigational agent
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to curcumin or vitamin D or other agents used in this study
- Patients on therapeutic anticoagulation, with heparin (or low-molecular weight heparin), warfarin, or a direct thrombin inhibitor as the safety of concurrent administration of curcumin has not been established
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100423
United States, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 |
Principal Investigator: | Paolo Caimi | Case Comprehensive Cancer Center |
Responsible Party: | Paolo Caimi, MD, Principal Investigator, Case Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT02100423 |
Other Study ID Numbers: |
CASE5913 NCI-2014-00266 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CASE5913 ( Other Identifier: Case Comprehensive Cancer Center ) P30CA043703 ( U.S. NIH Grant/Contract ) |
First Posted: | April 1, 2014 Key Record Dates |
Last Update Posted: | January 18, 2020 |
Last Verified: | January 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Lymphoma Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Vitamin D Cholecalciferol Curcumin Vitamins |
Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |