Curcumin and Cholecalciferol in Treating Patients With Previously Untreated Stage 0-II Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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|ClinicalTrials.gov Identifier: NCT02100423|
Recruitment Status : Completed
First Posted : April 1, 2014
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Contiguous Stage II Small Lymphocytic Lymphoma Noncontiguous Stage II Small Lymphocytic Lymphoma Stage 0 Chronic Lymphocytic Leukemia Stage I Chronic Lymphocytic Leukemia Stage I Small Lymphocytic Lymphoma Stage II Chronic Lymphocytic Leukemia||Drug: curcumin Dietary Supplement: cholecalciferol Other: laboratory biomarker analysis Other: pharmacological study||Phase 2|
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).
I. To determine the time to first cytotoxic treatment (TFCT), progression free survival (PFS), and overall survival (OS) using this regimen.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||September 26, 2014|
|Actual Primary Completion Date :||April 4, 2018|
|Actual Study Completion Date :||December 13, 2018|
Experimental: Treatment (curcumin, cholecalciferol)
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.
Dietary Supplement: cholecalciferol
Other: laboratory biomarker analysis
Other: pharmacological study
Other Name: pharmacological studies
- Overall response rate (biologic response rate + complete response [CR] + partial response [PR]) based on NCI-WG (for CLL) and Cheson criteria (for SLL) [ Time Frame: The time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years ]The point estimate of the overall response rate and biologic response rate along with 95% confidence intervals will be calculated using binomial distribution theory.
- Time to first cytotoxic treatment [ Time Frame: Time from entry onto study until initiation of treatment with cytotoxic agents because of disease progression, assessed up to 2 years ]Kaplan-Meier method and Cox proportional hazard model will be used for the data analysis.
- Progression free survival [ Time Frame: Time from entry onto study until CLL/SLL progression or death from any cause, assessed up to 2 years ]Kaplan-Meier method and Cox proportional hazard model will be used for the data analysis.
- Overall survival [ Time Frame: Up to 2 years ]Kaplan-Meier method and Cox proportional hazard model will be used for the data analysis.
- Duration of response [ Time Frame: Up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100423
|United States, Ohio|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Principal Investigator:||Paolo Caimi||Case Comprehensive Cancer Center|