Trial Outcomes & Findings for Curcumin and Cholecalciferol in Treating Patients With Previously Untreated Stage 0-II Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT NCT02100423)
NCT ID: NCT02100423
Last Updated: 2024-04-12
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2024-04-12
Participant Flow
Participant milestones
| Measure |
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.
curcumin: Given PO
cholecalciferol: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
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.
curcumin: Given PO
cholecalciferol: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Curcumin and Cholecalciferol in Treating Patients With Previously Untreated Stage 0-II Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Curcumin, Cholecalciferol)
n=35 Participants
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.
curcumin: Given PO
cholecalciferol: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Age, Customized
40-49 years
|
1 Participants
n=99 Participants
|
|
Age, Customized
50-59 years
|
17 Participants
n=99 Participants
|
|
Age, Customized
60-69 years
|
12 Participants
n=99 Participants
|
|
Age, Customized
70-79 years
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Participants enrolled in study
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
Outcome measures
| Measure |
Treatment (Curcumin, Cholecalciferol)
n=35 Participants
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.
curcumin: Given PO
cholecalciferol: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Overall Response Rate Based on NCI-WG (for CLL) and Cheson Criteria (for SLL)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Evaluable participants who progressed. Two additional participants were recorded to have progressed but data are missing regarding TFCT and all efforts to retrieve information have been exhausted.
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.
Outcome measures
| Measure |
Treatment (Curcumin, Cholecalciferol)
n=4 Participants
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.
curcumin: Given PO
cholecalciferol: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Time to First Cytotoxic Treatment (TFCT)
|
10.5 Months
Interval 6.0 to 21.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Participants enrolled in study
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
Outcome measures
| Measure |
Treatment (Curcumin, Cholecalciferol)
n=35 Participants
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.
curcumin: Given PO
cholecalciferol: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Percent of Participants With Progression Free Survival (PFS)
|
57.5 percentage of participants
Interval 44.9 to 100.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Participants enrolled on study.
Number of participants still alive at 2 years after treatment discontinuation.
Outcome measures
| Measure |
Treatment (Curcumin, Cholecalciferol)
n=35 Participants
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.
curcumin: Given PO
cholecalciferol: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Overall Survival (OS)
|
35 participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: No participants analyzed because there was no therapeutic response
Time from achievement of partial response, complete response or biologic response to disease progression
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: Up to 2 years post-treatmentPopulation: Participants who received the Curcumin and Cholecalciferol treatment
Number of participants still alive at 2 years after treatment discontinuation.
Outcome measures
| Measure |
Treatment (Curcumin, Cholecalciferol)
n=35 Participants
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.
curcumin: Given PO
cholecalciferol: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Median Overall Survival (OS)
|
35 Participants
|
Adverse Events
Treatment (Curcumin, Cholecalciferol)
Serious events: 1 serious events
Other events: 33 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment (Curcumin, Cholecalciferol)
n=35 participants at risk
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.
curcumin: Given PO
cholecalciferol: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
Other adverse events
| Measure |
Treatment (Curcumin, Cholecalciferol)
n=35 participants at risk
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.
curcumin: Given PO
cholecalciferol: Given PO
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
7/35 • Number of events 12 • Through study completion, which was an average of 4 years.
|
|
Ear and labyrinth disorders
Hearing Impaired
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Endocrine disorders
Intermittent night sweats
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Endocrine disorders
Hypothyroidism
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Eye disorders
Blurred vision
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
2/35 • Number of events 2 • Through study completion, which was an average of 4 years.
|
|
Gastrointestinal disorders
Bloating
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Gastrointestinal disorders
Diarrhea
|
37.1%
13/35 • Number of events 45 • Through study completion, which was an average of 4 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Gastrointestinal disorders
Stomach cramps
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Gastrointestinal disorders
Stool color change
|
11.4%
4/35 • Number of events 4 • Through study completion, which was an average of 4 years.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
5/35 • Number of events 6 • Through study completion, which was an average of 4 years.
|
|
Gastrointestinal disorders
Rectal pain
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
General disorders
Chills
|
5.7%
2/35 • Number of events 2 • Through study completion, which was an average of 4 years.
|
|
General disorders
Edema limbs
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
General disorders
Fatigue
|
40.0%
14/35 • Number of events 17 • Through study completion, which was an average of 4 years.
|
|
General disorders
Fever
|
5.7%
2/35 • Number of events 2 • Through study completion, which was an average of 4 years.
|
|
General disorders
Flu like symptoms
|
5.7%
2/35 • Number of events 2 • Through study completion, which was an average of 4 years.
|
|
General disorders
Malaise
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
General disorders
Pain
|
8.6%
3/35 • Number of events 5 • Through study completion, which was an average of 4 years.
|
|
Infections and infestations
Infection under chin
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Infections and infestations
Lymph gland infection
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Infections and infestations
Nail infection
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Infections and infestations
Papulopustular rash
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Infections and infestations
Sinusitis
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Infections and infestations
Skin infection
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Infections and infestations
Tooth infection
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Infections and infestations
Upper respiratory infection
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Infections and infestations
Urinary tract infection
|
5.7%
2/35 • Number of events 2 • Through study completion, which was an average of 4 years.
|
|
Injury, poisoning and procedural complications
Bruising
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Investigations
Alanine aminotransferase increased
|
11.4%
4/35 • Number of events 5 • Through study completion, which was an average of 4 years.
|
|
Investigations
Alkaline phosphatase increased
|
17.1%
6/35 • Number of events 8 • Through study completion, which was an average of 4 years.
|
|
Investigations
Aspartate aminotransferase increased
|
8.6%
3/35 • Number of events 5 • Through study completion, which was an average of 4 years.
|
|
Investigations
Blood bilirubin increased
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Investigations
Creatinine increased
|
11.4%
4/35 • Number of events 7 • Through study completion, which was an average of 4 years.
|
|
Investigations
White blood cell count increased
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Investigations
Lymphocyte count decreased
|
14.3%
5/35 • Number of events 6 • Through study completion, which was an average of 4 years.
|
|
Investigations
Lymphocyte count increased
|
20.0%
7/35 • Number of events 8 • Through study completion, which was an average of 4 years.
|
|
Investigations
Neutrophil count decreased
|
5.7%
2/35 • Number of events 2 • Through study completion, which was an average of 4 years.
|
|
Investigations
Platelet count decreased
|
25.7%
9/35 • Number of events 13 • Through study completion, which was an average of 4 years.
|
|
Investigations
Weight gain
|
5.7%
2/35 • Number of events 2 • Through study completion, which was an average of 4 years.
|
|
Investigations
Weight loss
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Investigations
White blood cell decreased
|
2.9%
1/35 • Number of events 3 • Through study completion, which was an average of 4 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.9%
1/35 • Number of events 2 • Through study completion, which was an average of 4 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
11.4%
4/35 • Number of events 4 • Through study completion, which was an average of 4 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
34.3%
12/35 • Number of events 24 • Through study completion, which was an average of 4 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.9%
1/35 • Number of events 3 • Through study completion, which was an average of 4 years.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.7%
2/35 • Number of events 2 • Through study completion, which was an average of 4 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.6%
3/35 • Number of events 4 • Through study completion, which was an average of 4 years.
|
|
Metabolism and nutrition disorders
low vitamin D level
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.7%
2/35 • Number of events 2 • Through study completion, which was an average of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Night sweats
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
2/35 • Number of events 3 • Through study completion, which was an average of 4 years.
|
|
Nervous system disorders
Dizziness
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Nervous system disorders
Dysesthesia
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Nervous system disorders
Headache
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Nervous system disorders
Flu like symptoms, body aches
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Nervous system disorders
Sinus pain
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Psychiatric disorders
Anxiety
|
8.6%
3/35 • Number of events 3 • Through study completion, which was an average of 4 years.
|
|
Psychiatric disorders
Depression
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Psychiatric disorders
Insomnia
|
8.6%
3/35 • Number of events 3 • Through study completion, which was an average of 4 years.
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Renal and urinary disorders
Hematuria
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Renal and urinary disorders
Dysuria
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.7%
2/35 • Number of events 2 • Through study completion, which was an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
5/35 • Number of events 5 • Through study completion, which was an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.7%
2/35 • Number of events 2 • Through study completion, which was an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.7%
2/35 • Number of events 2 • Through study completion, which was an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Chest congestion
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
8.6%
3/35 • Number of events 3 • Through study completion, which was an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Brittle nails
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Skin integrity
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Vascular disorders
Hot flashes
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
|
Vascular disorders
Hypertension
|
14.3%
5/35 • Number of events 5 • Through study completion, which was an average of 4 years.
|
|
Vascular disorders
Night sweats
|
2.9%
1/35 • Number of events 1 • Through study completion, which was an average of 4 years.
|
Additional Information
Dr. Paolo Caimi
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Phone: 1-800-641-2422
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place