Curcumin and Cholecalciferol in Treating Patients With Previously Untreated Stage 0-II Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Completed · Phase 2

Conditions studied: 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

In brief

This phase II trial studies the efficacy (activity), and tolerability of curcumin and cholecalciferol combination in treating patients with previously untreated stage 0-II chronic lymphocytic leukemia or small lymphocytic lymphoma. Curcumin and cholecalciferol may prevent or slow the growth of cancer cells.

Key facts

Study ID

NCT02100423

Run by

Paolo Caimi, MD

People needed

35

Starts

2014-10-16

Expected to finish

2018-12-13

Last updated by the study team

2024-04-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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

Where it is running

• Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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