Trial Outcomes & Findings for Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant (NCT NCT02038153)

NCT ID: NCT02038153

Last Updated: 2020-05-14

Results Overview

The Relapse free survival rate is defined as the Leukemia free survival rate during the first two years after and during the initiation of treatment . The observed relapse free survival rate will be calculated along with its 95% confidence interval. A one sample test on proportion will be used to detect if the relapse free survival rate with lenalidomide is significantly higher than that without the treatment (relapse rate is expected to be \> 95%).

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: initial 2 years after treatment begins
• Results posted on: 2020-05-14

Participant Flow

Participant milestones

Measure	Treatment (Lenalidomide) Patients receive lenalidomide PO QD on days 1-21. Courses repeat 4 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Treatment (Lenalidomide) Patients receive lenalidomide PO QD on days 1-21. Courses repeat 4 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant

Baseline characteristics by cohort

Measure	Treatment (Lenalidomide) n=3 Participants Patients receive lenalidomide PO QD on days 1-21. Courses repeat 4 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants
Race/Ethnicity, Customized White	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: initial 2 years after treatment begins

Population: Study terminated because of low accrual. No analysis done

The Relapse free survival rate is defined as the Leukemia free survival rate during the first two years after and during the initiation of treatment . The observed relapse free survival rate will be calculated along with its 95% confidence interval. A one sample test on proportion will be used to detect if the relapse free survival rate with lenalidomide is significantly higher than that without the treatment (relapse rate is expected to be > 95%).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From transplant until death of any cause, assessed up to 5 years

Population: Study terminated because of low accrual. No analysis done

Kaplan-Meier analysis will be conducted.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (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

Dr. Ira Braunschweig

Montefiore

Phone: 718 920-4826

Email: ibraunsc@montefiore.org

Results disclosure agreements

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