18 and older, any sex, with Contiguous Stage II Small Lymphocytic Lymphoma or Noncontiguous Stage II Small Lymphocytic Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate Based on NCI-WG (for CLL) and Cheson Criteria (for SLL)Primary· Up to 2 years
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
Group
Value
95% CI
Treatment (Curcumin, Cholecalciferol)
0
Time to First Cytotoxic Treatment (TFCT)Secondary· Up to 2 years
TFCT defined as the time from entry onto study until initiation of treatment with cytotoxic agents because of disease progression.
Kaplan-Meier method and Cox proportional hazard model will be used for the data analysis.
Group
Value
95% CI
Treatment (Curcumin, Cholecalciferol)
10.5
6 – 21
Percent of Participants With Progression Free Survival (PFS)Secondary· Up to 2 years
Percent of participants that reached 2-year survival without disease progression.
PFS is defined as the time from entry onto study until CLL/SLL progression or death from any cause. National Cancer Institute Working Group (NCI-WG) criteria is used for CLL participants and Cheson Criteria is used for SLL participants
Group
Value
95% CI
Treatment (Curcumin, Cholecalciferol)
57.5
44.9 – 100
Overall Survival (OS)Secondary· Up to 2 years
Number of participants still alive at 2 years after treatment discontinuation.
Group
Value
95% CI
Treatment (Curcumin, Cholecalciferol)
35
Median Overall Survival (OS)Secondary· Up to 2 years post-treatment
Number of participants still alive at 2 years after treatment discontinuation.
Group
Value
95% CI
Treatment (Curcumin, Cholecalciferol)
35
Adverse events — posted to ClinicalTrials.gov
Time frame: Through study completion, which was an average of 4 years..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06053411 — Contribution of UGT2B17 to the Pharmacokinetics of Diclofenac
· EARLY_PHASE1
· recruiting
NCT05975866 — The Effects of an Anti-inflammatory Diet With or Without Curcumin Supplementation on Anthropometric Measurements, Concen
· NA
· unknown
NCT06006663 — Effect of Hebal and Synthetic Medicamentss on Enterococcus Feacalis
· Phase 2, PHASE3
· unknown
NCT06553144 — Comparative Analysis of Photodynamic Therapy on Periapical Healing
· NA
· completed
NCT03746158 — Interindividual Variation in Excretion of Curcumin
· NA
· completed
Other Paolo Caimi, MD trials
Trials by the same sponsor.
NCT06916767 — Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia / Small
· Phase 1
· recruiting
NCT01820624 — Lithium Carbonate and Tretinoin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Paolo Caimi, MD
Last refreshed: 12 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02100423.