Clinical trial NCT02100423 (phase 2, status: completed)
Conditions: 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
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, C91.11, C91.12, C91.10, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, C91.11, C91.12, C91.10
Drugs: curcumin
SMILES: COC1=CC(\C=C\C(=O)CC(=O)\C=C\C2=CC(OC)=C(O)C=C2)=CC=C1O
Eligibility criteria:

        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

          -  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