Trial Outcomes & Findings for Lenalidomide in HTLV-1 Adult T-Cell Leukemia (NCT NCT01274533)

Results Overview

Peripheral blood, CT or MRI

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

28 days

Results posted on

2016-05-23

Participant Flow

The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in Aug. 2013.

Participant milestones

Participant milestones
Measure	Lenalidomide Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons. Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Lenalidomide Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons. Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle
Overall Study Withdrawal by Subject	1
Overall Study Non-compliance	1
Overall Study Disease progression	2

Baseline Characteristics

Lenalidomide in HTLV-1 Adult T-Cell Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lenalidomide n=4 Participants Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons. Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle
Age, Customized 18 years and older	4 participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in Aug. 2013.

Peripheral blood, CT or MRI

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in Aug. 2013.

Outcome measures

Outcome data not reported

Adverse Events

Lenalidomide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

CU PRS Administrator

Columbia University

Phone: 212-342-1643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place