Trial Outcomes & Findings for Pilot Trial of Intravenous Vitamin C in Refractory Non-Hodgkin Lymphoma (NHL) (NCT NCT00626444)

NCT ID: NCT00626444

Last Updated: 2025-05-16

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

10 weeks

Results posted on

2025-05-16

Participant Flow

Participant milestones

Participant milestones
Measure
Vitamin C
Intravenous vitamin C Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks.
Overall Study
STARTED
2
Overall Study
COMPLETED
2
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Trial of Intravenous Vitamin C in Refractory Non-Hodgkin Lymphoma (NHL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Vitamin C
n=2 Participants
Intravenous vitamin C Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks.
Age, Continuous
55.3 years
STANDARD_DEVIATION 2.9 • n=5 Participants
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
1 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
2 participants
n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 weeks

Outcome measures

Outcome data not reported

Adverse Events

Vitamin C

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Vitamin C
n=2 participants at risk
Intravenous vitamin C Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks.
General disorders
Abdominal pain
50.0%
1/2 • Number of events 1
General disorders
Back pain
50.0%
1/2 • Number of events 1
General disorders
Induration at IV site
50.0%
1/2 • Number of events 1
General disorders
Lightheadedness
50.0%
1/2 • Number of events 1
General disorders
Nausea
50.0%
1/2 • Number of events 1
General disorders
Pain at IV site
50.0%
1/2 • Number of events 3
General disorders
Viral illness
50.0%
1/2 • Number of events 1

Additional Information

Daniel Monti, MD

Thomas Jefferson University

Phone: 215-955-4410

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place