Trial Outcomes & Findings for Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (NCT NCT01401322)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

12 weeks

Results posted on

2016-11-28

Participant milestones
Measure	Lenalidomide 50 mg/Day x 28 Days Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
Overall Study STARTED	5
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	2

Reasons for withdrawal
Measure	Lenalidomide 50 mg/Day x 28 Days Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	1

Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia

Baseline characteristics by cohort
Measure	Lenalidomide 50 mg/Day x 28 Days n=5 Participants Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
Age, Continuous	39.7 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

Timeframe: 12 weeks

Outcome measures
Measure	Lenalidomide 50 mg/Day x 28 Days n=3 Participants Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions. Lenalidomide: 50 mg; po
Time-to-Progression (TTP)	20 Days Interval 19.0 to 21.0

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Lenalidomide 50 mg/Day x 28 Days n=5 participants at risk Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
Blood and lymphatic system disorders Anemia	20.0% 1/5 • Number of events 1 • 12 weeks
Blood and lymphatic system disorders Febrile neutropenia	40.0% 2/5 • Number of events 2 • 12 weeks
Blood and lymphatic system disorders Blood and lymphatic system disorders-Other, Pancytopenia	20.0% 1/5 • Number of events 2 • 12 weeks
General disorders General disorders and administration site conditions - Other, failure to thrive	20.0% 1/5 • Number of events 1 • 12 weeks
Hepatobiliary disorders Hepatobiliary disorders - Other, abnormal liver function	20.0% 1/5 • Number of events 1 • 12 weeks
Infections and infestations Lung infection	20.0% 1/5 • Number of events 1 • 12 weeks

Adverse event data not reported

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