Trial Outcomes & Findings for Feasibility Study of Simvastatin in Hodgkin's Lymphoma Survivors (NCT NCT00746603)

Last Updated: 2021-03-02

Results Overview

Number of participants experiencing grade 3 or greater muscle toxicity as evaluated by creatinine kinase laboratory tests.

Recruitment status

TERMINATED

Study phase

Target enrollment

3 participants

Primary outcome timeframe

Up to 26 weeks

Results posted on

2021-03-02

Participant Flow

recruitment occurred in the late effects clinic

Participant milestones

Participant milestones
Measure	Simvastatin Escalating dose of simvastatin Simvastatin: All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40. Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility Study of Simvastatin in Hodgkin's Lymphoma Survivors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Simvastatin n=3 Participants Escalating dose of simvastatin Simvastatin: All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40. Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 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	0 Participants n=99 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=99 Participants
Region of Enrollment United States	3 participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 26 weeks

Population: The study terminated in 2009 due to poor enrollment. The principal investigator (PI) and study team are no longer at the institution and the PI has confirmed that the data no longer exists. There are no data to report.

Number of participants experiencing grade 3 or greater muscle toxicity as evaluated by creatinine kinase laboratory tests.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 26 Weeks

Number of participants experiencing grade 3 or higher liver toxicity as determined by liver function laboratory tests.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 26 Weeks

A change in CIMT measurements ( measured in millimeters (mm)) will be performed.

Outcome measures

Outcome data not reported

Adverse Events

Simvastatin

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	Simvastatin n=3 participants at risk Escalating dose of simvastatin Simvastatin: All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40. Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks.
Musculoskeletal and connective tissue disorders Creatine Kinase	33.3% 1/3 • Number of events 1
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • Number of events 1

Additional Information

Jennifer Levine, MD

Weill Cornell Medicine

Phone: 212-305-9770

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place