Curcumin and Cholecalciferol in Treating Patients With Previously Untreated Stage 0-II Chronic Ly… (NCT02100423) | Clinical Trial Compass
CompletedPhase 2
Curcumin and Cholecalciferol in Treating Patients With Previously Untreated Stage 0-II Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
United States35 participantsStarted 2014-10-16
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Subject…
What they're measuring
1
Overall Response Rate Based on NCI-WG (for CLL) and Cheson Criteria (for SLL)