Phase 2
Completed N=35
Curcumin and Cholecalciferol in Treating Patients With Previously Untreated Stage 0-II Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Source: ClinicalTrials.gov NCT02100423 ↗Enrolled (actual)
35
Serious AEs
2.9%
Results posted
Apr 2024
Primary outcomePrimary: Overall Response Rate Based on NCI-WG (for CLL) and Cheson Criteria (for SLL) — 0 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate Based on NCI-WG (for CLL) and Cheson Criteria (for SLL) |
— | — |
| SECONDARY Time to First Cytotoxic Treatment (TFCT) |
10.5 | — |
| SECONDARY Percent of Participants With Progression Free Survival (PFS) |
57.5 | — |
| SECONDARY Overall Survival (OS) |
35 | — |
| SECONDARY Duration of Response |
— | — |
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 = = 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
Data sourced from ClinicalTrials.gov (NCT02100423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.