Trial Outcomes & Findings for Lenalidomide in Treating Patients With High Risk Acute Myeloid Leukemia in Remission (NCT NCT02126553)
NCT ID: NCT02126553
Last Updated: 2022-11-14
Results Overview
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Up to 7 Years
Results posted on
2022-11-14
Participant Flow
Recruitment Period: November 2014 to November 2021
Participant milestones
| Measure |
Treatment (Lenalidomide)
Patients receive lenalidomide PO QD on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Lenalidomide: Given PO
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenalidomide in Treating Patients With High Risk Acute Myeloid Leukemia in Remission
Baseline characteristics by cohort
| Measure |
Treatment (Lenalidomide)
n=29 Participants
Patients receive lenalidomide PO QD on days 1-28. Treatment repeats every 28 days for up to 24 cycles 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
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 7 YearsTime from date of treatment start until the date of first objective documentation of disease-relapse.
Outcome measures
| Measure |
Treatment (Lenalidomide)
n=29 Participants
Patients receive lenalidomide PO QD on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Lenalidomide: Given PO
|
|---|---|
|
Relapse-free Survival (RFS)
|
21.5 Months
Interval 0.7 to 54.3
|
SECONDARY outcome
Timeframe: Up to 7 YearsTime from date of treatment start until date of death due to any cause or last Follow-up. Survival will be measured by the estimated median survival computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative survival drops below 50%, if present. If not present then the median Overall Survival is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis.
Outcome measures
| Measure |
Treatment (Lenalidomide)
n=29 Participants
Patients receive lenalidomide PO QD on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Lenalidomide: Given PO
|
|---|---|
|
Overall Survival (OS)
|
NA Months
Interval 1.3 to 54.0
Median not reached due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 7 YearsTime from date of treatment start until the date of first objective documentation of disease-relapse, death or discontinuation due to adverse events.
Outcome measures
| Measure |
Treatment (Lenalidomide)
n=29 Participants
Patients receive lenalidomide PO QD on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Lenalidomide: Given PO
|
|---|---|
|
Event-free Survival (EFS)
|
12 Months
Interval 0.5 to 54.3
|
SECONDARY outcome
Timeframe: Up to 7 yearsComplete Response is defined as disappearance of all clinical and/or radiologic evidence of disease, including extramedullary leukemia. Neutrophil count \>/= 1.0 x 10\^9/L and platelet count\>/= 100 x 10\^9, and bone marrow differential showing \</=5%blasts. Response date to loss of response or last follow up. Remission duration will be measured by the estimated median remission duration computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative remission duration drops below 50%, if present. If not present then median remission duration is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis.
Outcome measures
| Measure |
Treatment (Lenalidomide)
n=29 Participants
Patients receive lenalidomide PO QD on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Lenalidomide: Given PO
|
|---|---|
|
Complete Response (CR) Duration
|
NA Months
Interval 0.7 to 54.3
Median not reached due to insufficient number of partcipants.
|
Adverse Events
Treatment (Lenalidomide)
Serious events: 7 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Lenalidomide)
n=29 participants at risk
Patients receive lenalidomide PO QD on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Lenalidomide: Given PO
|
|---|---|
|
Infections and infestations
Cellulitis Hand
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
|
Metabolism and nutrition disorders
elevated transaminases
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
|
General disorders
Chest Pain
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
|
Infections and infestations
Cellulitis Foot
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
|
Infections and infestations
Bronchopneumonia
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
|
Nervous system disorders
Dysarthria
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
|
Cardiac disorders
Atrial Fibrillation
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
|
Infections and infestations
Pneumonia
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
Other adverse events
| Measure |
Treatment (Lenalidomide)
n=29 participants at risk
Patients receive lenalidomide PO QD on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Lenalidomide: Given PO
|
|---|---|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
6.9%
2/29 • Number of events 2 • Up to 7 years
|
|
Gastrointestinal disorders
Anorexia
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
|
Metabolism and nutrition disorders
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
3.4%
1/29 • Number of events 2 • Up to 7 years
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
|
Skin and subcutaneous tissue disorders
Itchy Scalp
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
|
Gastrointestinal disorders
Diarrhea
|
13.8%
4/29 • Number of events 4 • Up to 7 years
|
|
Nervous system disorders
Dizziness
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
|
Eye disorders
Dry eye syndrome
|
6.9%
2/29 • Number of events 2 • Up to 7 years
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
6.9%
2/29 • Number of events 2 • Up to 7 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.3%
3/29 • Number of events 3 • Up to 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
|
Blood and lymphatic system disorders
Edema: limb
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
20.7%
6/29 • Number of events 6 • Up to 7 years
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
13.8%
4/29 • Number of events 4 • Up to 7 years
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10^
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
|
Musculoskeletal and connective tissue disorders
Foot Cramps
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia Back and Neck
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
|
Musculoskeletal and connective tissue disorders
Myositis (inflammation/damage of muscle)
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
|
Gastrointestinal disorders
Nausea
|
10.3%
3/29 • Number of events 3 • Up to 7 years
|
|
Nervous system disorders
Neuropathy: motor
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
13.8%
4/29 • Number of events 4 • Up to 7 years
|
|
General disorders
Headache
|
6.9%
2/29 • Number of events 2 • Up to 7 years
|
|
General disorders
back pain
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
|
Blood and lymphatic system disorders
Platelets Thrombocytopenia
|
13.8%
4/29 • Number of events 4 • Up to 7 years
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
13.8%
4/29 • Number of events 4 • Up to 7 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
41.4%
12/29 • Number of events 12 • Up to 7 years
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
|
Eye disorders
Vision-photophobia
|
3.4%
1/29 • Number of events 1 • Up to 7 years
|
|
Gastrointestinal disorders
Vomiting
|
10.3%
3/29 • Number of events 3 • Up to 7 years
|
Additional Information
Tapan Kadia MD./Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-563-3534
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place