Trial Outcomes & Findings for Cholecalciferol in Newly Diagnosed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia With Vitamin D Deficiency (NCT NCT02553447)
NCT ID: NCT02553447
Last Updated: 2026-04-21
Results Overview
The 3-year progression-free survival will be presented using Kaplan-Meier curves and will be presented for the normal serum vitamin D control group and the low and high dose randomized groups. Each randomized group (low and high dose) will be compared to a historical fixed expected 3-year progression-free survival of 45% using a one-sample logrank test following the method of Woolson (1981). Progression was determined by Investigator assessment based on clinical evidence of disease relapse, progression requiring new therapy, or death from any cause.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
197 participants
Primary outcome timeframe
Time from the time of study entry of watch and wait or diagnosed non-Hodgkin lymphoma or chronic lymphocytic leukemia until relapse, progression, or death from any cause, assessed at 3 years
Results posted on
2026-04-21
Participant Flow
Participant milestones
| Measure |
Arm I (High-dose Cholecalciferol)
Patients receive high-dose cholecalciferol PO daily for 3 years in the absence of disease progression or unacceptable toxicity.
Cholecalciferol: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
|
Arm II (Low-dose Cholecalciferol)
Patients receive low-dose cholecalciferol PO daily for 3 years in the absence of disease progression or unacceptable toxicity.
Cholecalciferol: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
|
Arm III (Control)
Patients receive no intervention.
|
|---|---|---|---|
|
Overall Study
STARTED
|
35
|
36
|
108
|
|
Overall Study
COMPLETED
|
35
|
36
|
108
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
1 subject is missing height, weight and BMI
Baseline characteristics by cohort
| Measure |
Arm I (High-dose Cholecalciferol)
n=35 Participants
Patients receive high-dose cholecalciferol PO daily for 3 years in the absence of disease progression or unacceptable toxicity.
Cholecalciferol: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
|
Arm II (Low-dose Cholecalciferol)
n=36 Participants
Patients receive low-dose cholecalciferol PO daily for 3 years in the absence of disease progression or unacceptable toxicity.
Cholecalciferol: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
|
Arm III (Control)
n=108 Participants
Patients receive no intervention.
|
Total
n=179 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 12.53 • n=35 Participants
|
60.1 years
STANDARD_DEVIATION 12.81 • n=36 Participants
|
61.0 years
STANDARD_DEVIATION 13.13 • n=108 Participants
|
60.76 years
STANDARD_DEVIATION 12.88 • n=179 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=35 Participants
|
9 Participants
n=36 Participants
|
55 Participants
n=108 Participants
|
80 Participants
n=179 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=35 Participants
|
27 Participants
n=36 Participants
|
53 Participants
n=108 Participants
|
99 Participants
n=179 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=35 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=108 Participants
|
5 Participants
n=179 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=35 Participants
|
35 Participants
n=36 Participants
|
105 Participants
n=108 Participants
|
173 Participants
n=179 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=35 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=108 Participants
|
1 Participants
n=179 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=35 Participants
|
1 participants
n=36 Participants
|
0 participants
n=108 Participants
|
1 participants
n=179 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=35 Participants
|
0 participants
n=36 Participants
|
1 participants
n=108 Participants
|
1 participants
n=179 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 participants
n=35 Participants
|
1 participants
n=36 Participants
|
2 participants
n=108 Participants
|
6 participants
n=179 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=35 Participants
|
1 participants
n=36 Participants
|
1 participants
n=108 Participants
|
2 participants
n=179 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=35 Participants
|
0 participants
n=36 Participants
|
0 participants
n=108 Participants
|
2 participants
n=179 Participants
|
|
Race/Ethnicity, Customized
White
|
30 participants
n=35 Participants
|
33 participants
n=36 Participants
|
104 participants
n=108 Participants
|
167 participants
n=179 Participants
|
|
Weight, kg
|
97.2 kg
STANDARD_DEVIATION 26.73 • n=35 Participants • 1 subject is missing height, weight and BMI
|
99.1 kg
STANDARD_DEVIATION 30.40 • n=36 Participants • 1 subject is missing height, weight and BMI
|
87.5 kg
STANDARD_DEVIATION 23.10 • n=107 Participants • 1 subject is missing height, weight and BMI
|
91.76 kg
STANDARD_DEVIATION 26.36 • n=178 Participants • 1 subject is missing height, weight and BMI
|
|
BMI
|
32.7 kg/m2
STANDARD_DEVIATION 7.64 • n=35 Participants • 2 subjects are missing height and BMI \& 1 Subject is missing height, weight and BMI
|
32.2 kg/m2
STANDARD_DEVIATION 8.92 • n=35 Participants • 2 subjects are missing height and BMI \& 1 Subject is missing height, weight and BMI
|
29.9 kg/m2
STANDARD_DEVIATION 6.48 • n=106 Participants • 2 subjects are missing height and BMI \& 1 Subject is missing height, weight and BMI
|
30.91 kg/m2
STANDARD_DEVIATION 7.32 • n=176 Participants • 2 subjects are missing height and BMI \& 1 Subject is missing height, weight and BMI
|
|
Serum 25-Hydroxyvitamin D
|
21.0 ng/ml
STANDARD_DEVIATION 6.87 • n=35 Participants
|
20.1 ng/ml
STANDARD_DEVIATION 6.52 • n=36 Participants
|
43.3 ng/ml
STANDARD_DEVIATION 11.75 • n=108 Participants
|
34.27 ng/ml
STANDARD_DEVIATION 15.00 • n=179 Participants
|
|
Disease Group, n(%)
Aggressive
|
13 Participants
n=35 Participants
|
15 Participants
n=36 Participants
|
24 Participants
n=108 Participants
|
52 Participants
n=179 Participants
|
|
Disease Group, n(%)
Indolent
|
22 Participants
n=35 Participants
|
21 Participants
n=36 Participants
|
84 Participants
n=108 Participants
|
127 Participants
n=179 Participants
|
PRIMARY outcome
Timeframe: Time from the time of study entry of watch and wait or diagnosed non-Hodgkin lymphoma or chronic lymphocytic leukemia until relapse, progression, or death from any cause, assessed at 3 yearsThe 3-year progression-free survival will be presented using Kaplan-Meier curves and will be presented for the normal serum vitamin D control group and the low and high dose randomized groups. Each randomized group (low and high dose) will be compared to a historical fixed expected 3-year progression-free survival of 45% using a one-sample logrank test following the method of Woolson (1981). Progression was determined by Investigator assessment based on clinical evidence of disease relapse, progression requiring new therapy, or death from any cause.
Outcome measures
| Measure |
Arm I (High-dose Cholecalciferol)
n=35 Participants
Patients receive high-dose cholecalciferol PO daily for 3 years in the absence of disease progression or unacceptable toxicity.
Cholecalciferol: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
|
Arm II (Low-dose Cholecalciferol)
n=36 Participants
Patients receive low-dose cholecalciferol PO daily for 3 years in the absence of disease progression or unacceptable toxicity.
Cholecalciferol: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
|
Arm III (Control)
n=108 Participants
Patients receive no intervention.
|
|---|---|---|---|
|
Progression-free Survival
|
0.839 Proportion of participants
Interval 0.653 to 0.93
|
0.893 Proportion of participants
Interval 0.702 to 0.964
|
0.827 Proportion of participants
Interval 0.738 to 0.887
|
SECONDARY outcome
Timeframe: Up to 30 daysWill be described for the low dose and high dose groups and compared between groups using a Chi-square. The frequency of occurrence of overall toxicity, categorized by toxicity grades, will be described for the low dose and high dose groups and compared between groups using a Chi-square.
Outcome measures
| Measure |
Arm I (High-dose Cholecalciferol)
n=35 Participants
Patients receive high-dose cholecalciferol PO daily for 3 years in the absence of disease progression or unacceptable toxicity.
Cholecalciferol: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
|
Arm II (Low-dose Cholecalciferol)
n=36 Participants
Patients receive low-dose cholecalciferol PO daily for 3 years in the absence of disease progression or unacceptable toxicity.
Cholecalciferol: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
|
Arm III (Control)
n=108 Participants
Patients receive no intervention.
|
|---|---|---|---|
|
Incidence of Adverse Events and Serious Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Time from the time of study entry of watch and wait or newly diagnosed non-Hodgkin lymphoma or chronic lymphocytic leukemia administered on trial until death from any cause, assessed at 3 yearsThe 3-year overall survival will be presented using Kaplan-Meier curves and will be presented for the normal serum vitamin D control group and the low and high dose randomized groups. Each randomized group (low and high dose) will be compared to a historical fixed expected 3-year overall survival of 80% using a one-sample logrank test following the method of Woolson (1981).
Outcome measures
| Measure |
Arm I (High-dose Cholecalciferol)
n=35 Participants
Patients receive high-dose cholecalciferol PO daily for 3 years in the absence of disease progression or unacceptable toxicity.
Cholecalciferol: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
|
Arm II (Low-dose Cholecalciferol)
n=36 Participants
Patients receive low-dose cholecalciferol PO daily for 3 years in the absence of disease progression or unacceptable toxicity.
Cholecalciferol: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
|
Arm III (Control)
n=108 Participants
Patients receive no intervention.
|
|---|---|---|---|
|
Overall Survival
|
0.860 Proportion of participants
Interval 0.666 to 0.946
|
0.972 Proportion of participants
Interval 0.772 to 0.995
|
0.942 Proportion of participants
Interval 0.876 to 0.974
|
Adverse Events
Arm I (High-dose Cholecalciferol)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 4 deaths
Arm II (Low-dose Cholecalciferol)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths
Arm III (Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (High-dose Cholecalciferol)
n=35 participants at risk
Patients receive high-dose cholecalciferol PO daily for 3 years in the absence of disease progression or unacceptable toxicity.
Cholecalciferol: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
|
Arm II (Low-dose Cholecalciferol)
n=36 participants at risk
Patients receive low-dose cholecalciferol PO daily for 3 years in the absence of disease progression or unacceptable toxicity.
Cholecalciferol: Given PO
Laboratory Biomarker Analysis: Optional correlative studies
|
Arm III (Control)
n=108 participants at risk
Patients receive no intervention.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Tumor Lysis syndrome
|
2.9%
1/35 • Number of events 1 • From the initiation first dose of study treatment through the treatment period (Up to 3 Years and 1 month)
|
0.00%
0/36 • From the initiation first dose of study treatment through the treatment period (Up to 3 Years and 1 month)
|
0.00%
0/108 • From the initiation first dose of study treatment through the treatment period (Up to 3 Years and 1 month)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place