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CompletedNCT02100423Updated Apr 12, 2024Results posted

Curcumin and Cholecalciferol in Treating Patients With Previously Untreated Stage 0-II Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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

Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • 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
03

In context

Lymphoma

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.

Browse Lymphoma studies →

Lead sponsor

Paolo Caimi, MD is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • 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.

    Drug: curcumin · Dietary Supplement: cholecalciferol · Other: laboratory biomarker analysis · Other: pharmacological study

Interventions

  • Drugcurcumin

    Given PO

    Also known as: C.I. 75300, C.I. Natural Yellow 3, CU, Diferuloylmethane

  • Dietary supplementcholecalciferol

    Given PO

    Also known as: Calciol, Vitamin D3

  • Otherlaboratory biomarker analysis

    Correlative studies

  • Otherpharmacological study

    Correlative studies

    Also known as: pharmacological studies

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Overall Survival (OS)

    Number of participants still alive at 2 years after treatment discontinuation.

    Time frame: Up to 2 years

  4. Duration of Response

    Time from achievement of partial response, complete response or biologic response to disease progression

    Time frame: Up to 2 years

07

Results

Posted Apr 12, 2024

Participant flow

Participant flow — Overall Study
MilestoneTreatment (Curcumin, Cholecalciferol)
Started35
Completed29
Not completed6
Withdrew: Death1
Withdrew: Withdrawal by subject3
Withdrew: Adverse event1
Withdrew: Physician decision1

Outcome measures

PrimaryOverall 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
Reported as:
Number · percentage of participants
Overall Response Rate Based on NCI-WG (for CLL) and Cheson Criteria (for SLL)
percentage of participantsTreatment (Curcumin, Cholecalciferol)
Overall Response Rate Based on NCI-WG (for CLL) and Cheson Criteria (for SLL)0
SecondaryTime 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
Reported as:
Median · Months
Time to First Cytotoxic Treatment (TFCT)
MonthsTreatment (Curcumin, Cholecalciferol)
Time to First Cytotoxic Treatment (TFCT)10.5 (6 to 21)
SecondaryPercent 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
Reported as:
Number · percentage of participants
Percent of Participants With Progression Free Survival (PFS)
percentage of participantsTreatment (Curcumin, Cholecalciferol)
Percent of Participants With Progression Free Survival (PFS)57.5 (44.9 to 100)
SecondaryOverall Survival (OS)

Number of participants still alive at 2 years after treatment discontinuation.

Time frame:
Up to 2 years
Reported as:
Number · participants
Overall Survival (OS)
participantsTreatment (Curcumin, Cholecalciferol)
Overall Survival (OS)35
SecondaryDuration of Response

Time from achievement of partial response, complete response or biologic response to disease progression

Time frame:
Up to 2 years

No measurements were reported for this outcome.

Post-hocMedian Overall Survival (OS)

Number of participants still alive at 2 years after treatment discontinuation.

Time frame:
Up to 2 years post-treatment
Reported as:
Count of participants · Participants
Median Overall Survival (OS)
ParticipantsTreatment (Curcumin, Cholecalciferol)
Median Overall Survival (OS)35

Adverse events

Collected over Through study completion, which was an average of 4 years.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (Curcumin, Cholecalciferol)1/35 (2.9%)1/35 (2.9%)33/35 (94.3%)
Most frequent serious events
Most frequent serious events
EventTreatment (Curcumin, Cholecalciferol)
DiarrheaGastrointestinal disorders1/35
Most frequent other events
Showing 10 of 82
Most frequent other events
EventTreatment (Curcumin, Cholecalciferol)
FatigueGeneral disorders14/35
DiarrheaGastrointestinal disorders13/35
HyperglycemiaMetabolism and nutrition disorders12/35
Platelet count decreasedInvestigations9/35
AnemiaBlood and lymphatic system disorders7/35
Lymphocyte count increasedInvestigations7/35
Alkaline phosphatase increasedInvestigations6/35
NauseaGastrointestinal disorders5/35
Lymphocyte count decreasedInvestigations5/35
CoughRespiratory, thoracic and mediastinal disorders5/35

Baseline characteristics

Participants enrolled in study

Age, Customized
Age, Customized(Participants)Treatment (Curcumin, Cholecalciferol)
40-49 years1
50-59 years17
60-69 years12
70-79 years5
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (Curcumin, Cholecalciferol)
Female17
Male18
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Treatment (Curcumin, Cholecalciferol)
Hispanic or Latino0
Not Hispanic or Latino35
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment (Curcumin, Cholecalciferol)
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American2
White33
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Treatment (Curcumin, Cholecalciferol)
United States35
08

Study locations

1 site
  • Case Comprehensive Cancer Center
    Cleveland, Ohio 44106-5065, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 2, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02100423
Lead sponsor
Paolo Caimi, MD
Responsible party
Paolo Caimi, MD (Principal Investigator, Case Comprehensive Cancer Center) — Sponsor-investigator
First posted
Apr 1, 2014
Start date
Oct 16, 2014
Primary completion
Apr 4, 2018
Completion
Dec 13, 2018
Results posted
Apr 12, 2024
Last update
Apr 12, 2024

Study contacts

Paolo Caimi
principal investigator · Case Comprehensive Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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