A Phase 2 interventional study of curcumin and cholecalciferol in Contiguous Stage II Small Lymphocytic Lymphoma, Noncontiguous Stage II Small Lymphocytic Lymphoma and Stage 0 Chronic Lymphocytic Leukemia, sponsored by Paolo Caimi, MD. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by Paolo Caimi, MD · Phase 2, Interventional, and Treatment
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.
PRIMARY OBJECTIVES:
I. To determine the overall response rate (ORR) based on National Cancer Institute-Working Group (NCI-WG) criteria in chronic lymphocytic leukemia (CLL) or the Cheson criteria in small lymphocytic lymphoma (SLL).
SECONDARY OBJECTIVES:
I. To determine the time to first cytotoxic treatment (TFCT), progression free survival (PFS), and overall survival (OS) using this regimen.
OUTLINE:
Patients receive curcumin orally (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.
After completion of study treatment, patients are followed up for 30 days and then every 3-6 months for 2 years.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 35 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
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Exclusion Criteria:
Concurrent medical condition which may increase the risk of toxicity, including:
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.
Drug: curcumin · Dietary Supplement: cholecalciferol · Other: laboratory biomarker analysis · Other: pharmacological study
Given PO
Also known as: C.I. 75300, C.I. Natural Yellow 3, CU, Diferuloylmethane
Given PO
Also known as: Calciol, Vitamin D3
Correlative studies
Correlative studies
Also known as: pharmacological studies
Overall Response Rate Based on NCI-WG (for CLL) and Cheson Criteria (for SLL)
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
Time frame: Up to 2 years
Time to First Cytotoxic Treatment (TFCT)
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.
Time frame: Up to 2 years
Percent of Participants With Progression Free Survival (PFS)
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
Time frame: Up to 2 years
Overall Survival (OS)
Number of participants still alive at 2 years after treatment discontinuation.
Time frame: Up to 2 years
Duration of Response
Time from achievement of partial response, complete response or biologic response to disease progression
Time frame: Up to 2 years
| Milestone | Treatment (Curcumin, Cholecalciferol) |
|---|---|
| Started | 35 |
| Completed | 29 |
| Not completed | 6 |
| Withdrew: Death | 1 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Adverse event | 1 |
| Withdrew: Physician decision | 1 |
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
| percentage of participants | Treatment (Curcumin, Cholecalciferol) |
|---|---|
| Overall Response Rate Based on NCI-WG (for CLL) and Cheson Criteria (for SLL) | 0 |
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.
| Months | Treatment (Curcumin, Cholecalciferol) |
|---|---|
| Time to First Cytotoxic Treatment (TFCT) | 10.5 (6 to 21) |
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
| percentage of participants | Treatment (Curcumin, Cholecalciferol) |
|---|---|
| Percent of Participants With Progression Free Survival (PFS) | 57.5 (44.9 to 100) |
Number of participants still alive at 2 years after treatment discontinuation.
| participants | Treatment (Curcumin, Cholecalciferol) |
|---|---|
| Overall Survival (OS) | 35 |
Time from achievement of partial response, complete response or biologic response to disease progression
No measurements were reported for this outcome.
Number of participants still alive at 2 years after treatment discontinuation.
| Participants | Treatment (Curcumin, Cholecalciferol) |
|---|---|
| Median Overall Survival (OS) | 35 |
Collected over Through study completion, which was an average of 4 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Curcumin, Cholecalciferol) | 1/35 (2.9%) | 1/35 (2.9%) | 33/35 (94.3%) |
| Event | Treatment (Curcumin, Cholecalciferol) |
|---|---|
| DiarrheaGastrointestinal disorders | 1/35 |
| Event | Treatment (Curcumin, Cholecalciferol) |
|---|---|
| FatigueGeneral disorders | 14/35 |
| DiarrheaGastrointestinal disorders | 13/35 |
| HyperglycemiaMetabolism and nutrition disorders | 12/35 |
| Platelet count decreasedInvestigations | 9/35 |
| AnemiaBlood and lymphatic system disorders | 7/35 |
| Lymphocyte count increasedInvestigations | 7/35 |
| Alkaline phosphatase increasedInvestigations | 6/35 |
| NauseaGastrointestinal disorders | 5/35 |
| Lymphocyte count decreasedInvestigations | 5/35 |
| CoughRespiratory, thoracic and mediastinal disorders | 5/35 |
Participants enrolled in study
| Age, Customized(Participants) | Treatment (Curcumin, Cholecalciferol) |
|---|---|
| 40-49 years | 1 |
| 50-59 years | 17 |
| 60-69 years | 12 |
| 70-79 years | 5 |
| Sex: Female, Male(Participants) | Treatment (Curcumin, Cholecalciferol) |
|---|---|
| Female | 17 |
| Male | 18 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (Curcumin, Cholecalciferol) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 35 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment (Curcumin, Cholecalciferol) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 33 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Treatment (Curcumin, Cholecalciferol) |
|---|---|
| United States | 35 |
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Paolo Caimi, MD