Clinical trial · Interventional
Curcumin and Cholecalciferol in Treating Patients With Previously Untreated Stage 0-II Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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)
NCT02100423CI-TRIAL-00075998completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Contiguous Stage II Small Lymphocytic Lymphoma | — | UNRESOLVED | — |
| Noncontiguous Stage II Small Lymphocytic Lymphoma | — | UNRESOLVED | — |
| Stage 0 Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
| Stage I Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
| Stage II Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
| Stage I Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cholecalciferol | Dietary Supplement | — | UNRESOLVED |
| curcumin | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (curcumin, cholecalciferol)
- description
- 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.
- interventionNames
- Drug: curcumin
- Dietary Supplement: cholecalciferol
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (1)
- measure
- Overall Response Rate Based on NCI-WG (for CLL) and Cheson Criteria (for SLL)
- timeFrame
- Up to 2 years
- description
- The point estimate of the overall response rate (biologic response rate + complete response \[CR\] + partial response \[PR\]) with 95% confidence intervals will be calculated using binomial distribution theory. The time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented and assessed
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.