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Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT00352365
Recruitment Status : Completed
First Posted : July 14, 2006
Results First Posted : July 4, 2013
Last Update Posted : July 31, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Acute Basophilic Leukemia
Adult Acute Eosinophilic Leukemia
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Acute Myelomonocytic Leukemia (M4)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
Secondary Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Intervention Drug: lenalidomide
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lenalidomide
Hide Arm/Group Description Induction Therapy: Oral lenalidomide once daily on days 1-14, 1-21, or 1-28. Maintenance Therapy: Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
Period Title: Induction Therapy
Started 41
Eligible 38
Eligible and Began Protocol Therapy 37
Completed 14
Not Completed 27
Reason Not Completed
Adverse Event             7
Progression/Relapse             8
Death             7
Not protocol specified             1
Not eligible             3
Death before starting protocol therapy             1
Period Title: Maintenance Therapy
Started 12
Eligible and Began Protocol Therapy 8
Completed 0
Not Completed 12
Reason Not Completed
Progression/Relapse             3
Death             2
Not protocol specified             3
Not eligible             4
Arm/Group Title Induction Therapy
Hide Arm/Group Description Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
Overall Number of Baseline Participants 37
Hide Baseline Analysis Population Description
Eligible patients who began protocol therapy
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 37 participants
73.7
(60.1 to 94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Female
21
  56.8%
Male
16
  43.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants
Black or African American 3
White 33
Unknown or Not Reported 1
Hispanic  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants
Yes 1
No 32
Unknown 4
Disease Onset  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants
De Novo 16
Treatment related 2
MDS related 19
Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants
0 7
1 30
[1]
Measure Description: Performance status is graded according to the Zubrod Performance Status Scale. Patients with a performance status of 0 are fully active, able to carry on all pre-disease performance without restriction. Patients with a performance status of 1 are restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work.
1.Primary Outcome
Title Complete Response
Hide Description Morphologic complete remission (CR): ANC >=1,000/mcl, platelet count >=100,000/mcl, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who began protocol therapy
Arm/Group Title Induction Therapy
Hide Arm/Group Description:
Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
Overall Number of Participants Analyzed 37
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
11
(3 to 25)
2.Secondary Outcome
Title Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hide Description Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
Arm/Group Title Induction Therapy Maintenance Therapy
Hide Arm/Group Description:
Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
Overall Number of Participants Analyzed 37 8
Measure Type: Number
Unit of Measure: Participants
ALT, SGPT (serum glutamic pyruvic transaminase) 1 0
AST, SGOT 1 0
Adult respiratory distress syndrome (ARDS) 1 0
Anorexia 1 0
Bilirubin (hyperbilirubinemia) 1 0
Calcium, serum-low (hypocalcemia) 3 0
Cardiac-ischemia/infarction 1 0
Cough 1 0
Creatinine 3 0
Dermatology/Skin-Other (Specify) 1 0
Diarrhea 2 0
Dyspnea (shortness of breath) 2 0
Fatigue (asthenia, lethargy, malaise) 11 0
Febrile neutropenia 15 2
Glucose, serum-high (hyperglycemia) 2 0
Hemoglobin 7 2
Induration/fibrosis (skin and subcutaneous tissue) 0 1
Inf (clin/microbio) w/Gr 3-4 neuts - Esophagus 1 0
Inf (clin/microbio) w/Gr 3-4 neuts - Lip/perioral 1 0
Inf (clin/microbio) w/Gr 3-4 neuts - Lung 5 0
Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums 1 0
Inf (clin/microbio) w/Gr 3-4 neuts - Skin 1 0
Inf w/normal ANC or Gr 1-2 neutrophils - Blood 0 1
Leukocytes (total WBC) 14 4
Lymphopenia 2 0
Muscle weakness, not d/t neuropathy - body/general 3 0
Nausea 1 0
Neuropathy: motor 1 0
Neutrophils/granulocytes (ANC/AGC) 16 5
Platelets 21 3
Pneumonitis/pulmonary infiltrates 4 0
Potassium, serum-low (hypokalemia) 3 0
Pulmonary/Upper Respiratory-Other (Specify) 2 0
Rash/desquamation 2 0
Renal failure 1 0
Sodium, serum-high (hypernatremia) 1 0
Sodium, serum-low (hyponatremia) 1 1
Vomiting 1 0
3.Secondary Outcome
Title Cytogenetic Abnormalities
Hide Description Number of baseline cytogenetic abnormalities by responders (CR, CRi, and PR) and nonresponders.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Responders Nonresponders
Hide Arm/Group Description:
Eligible and evaluable patients who achieved CR/CRi/PR
Eligible and evaluable patients who did not achieve CR/CRi/PR
Overall Number of Participants Analyzed 5 32
Median (Full Range)
Unit of Measure: Number of abnormalities
8
(1 to 20)
8
(0 to 31)
4.Secondary Outcome
Title Total Response
Hide Description Morphologic complete remission (CR): ANC >=1,000/mcl, platelet count >=100,000/mcl, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl. Partial remission (PR): ANC >1,000/mcl, platelet count >100,000/mcl, and at least 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts <5% with persistent Auer rods.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who began protocol therapy
Arm/Group Title Induction Therapy
Hide Arm/Group Description:
Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
Overall Number of Participants Analyzed 37
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
14
(5 to 29)
Time Frame Up to 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Induction Therapy Maintenance Therapy
Hide Arm/Group Description Oral lenalidomide once daily on days 1-14, 1-21, or 1-28 Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
All-Cause Mortality
Induction Therapy Maintenance Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Induction Therapy Maintenance Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   24/37 (64.86%)   4/8 (50.00%) 
Blood and lymphatic system disorders     
Blood/Bone Marrow-Other (Specify)  1  1/37 (2.70%)  0/8 (0.00%) 
Febrile neutropenia  1  5/37 (13.51%)  2/8 (25.00%) 
Hemoglobin  1  2/37 (5.41%)  0/8 (0.00%) 
Cardiac disorders     
Cardiac-ischemia/infarction  1  2/37 (5.41%)  0/8 (0.00%) 
Gastrointestinal disorders     
Diarrhea  1  1/37 (2.70%)  0/8 (0.00%) 
Hemorrhage, GI - Colon  1  0/37 (0.00%)  1/8 (12.50%) 
General disorders     
Death not associated with CTCAE term - Death NOS  1  1/37 (2.70%)  0/8 (0.00%) 
Fatigue (asthenia, lethargy, malaise)  1  3/37 (8.11%)  0/8 (0.00%) 
Infections and infestations     
Inf (clin/microbio) w/Gr 3-4 neuts - Esophagus  1  1/37 (2.70%)  0/8 (0.00%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Lung  1  3/37 (8.11%)  0/8 (0.00%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums  1  1/37 (2.70%)  0/8 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Blood  1  1/37 (2.70%)  1/8 (12.50%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Lung  1  1/37 (2.70%)  0/8 (0.00%) 
Infection with unknown ANC - Blood  1  1/37 (2.70%)  0/8 (0.00%) 
Investigations     
ALT, SGPT (serum glutamic pyruvic transaminase)  1  1/37 (2.70%)  0/8 (0.00%) 
AST, SGOT  1  1/37 (2.70%)  0/8 (0.00%) 
Leukocytes (total WBC)  1  0/37 (0.00%)  1/8 (12.50%) 
Lymphopenia  1  1/37 (2.70%)  0/8 (0.00%) 
Platelets  1  3/37 (8.11%)  1/8 (12.50%) 
Metabolism and nutrition disorders     
Calcium, serum-low (hypocalcemia)  1  1/37 (2.70%)  0/8 (0.00%) 
Dehydration  1  1/37 (2.70%)  0/8 (0.00%) 
Potassium, serum-low (hypokalemia)  1  1/37 (2.70%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscle weakness, not d/t neuropathy - body/general  1  1/37 (2.70%)  0/8 (0.00%) 
Pain - Back  1  0/37 (0.00%)  1/8 (12.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Death - Disease progression NOS  1  8/37 (21.62%)  1/8 (12.50%) 
Nervous system disorders     
Pain - Head/headache  1  1/37 (2.70%)  0/8 (0.00%) 
Syncope (fainting)  1  1/37 (2.70%)  0/8 (0.00%) 
Renal and urinary disorders     
Renal failure  1  1/37 (2.70%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome (ARDS)  1  1/37 (2.70%)  0/8 (0.00%) 
Aspiration  1  1/37 (2.70%)  0/8 (0.00%) 
Dyspnea (shortness of breath)  1  3/37 (8.11%)  1/8 (12.50%) 
Pneumonitis/pulmonary infiltrates  1  3/37 (8.11%)  0/8 (0.00%) 
Skin and subcutaneous tissue disorders     
Induration/fibrosis (skin and subcutaneous tissue)  1  0/37 (0.00%)  1/8 (12.50%) 
Rash/desquamation  1  1/37 (2.70%)  0/8 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Induction Therapy Maintenance Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   34/37 (91.89%)   8/8 (100.00%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  11/37 (29.73%)  0/8 (0.00%) 
Hemoglobin  1  23/37 (62.16%)  5/8 (62.50%) 
Gastrointestinal disorders     
Constipation  1  3/37 (8.11%)  1/8 (12.50%) 
Diarrhea  1  8/37 (21.62%)  2/8 (25.00%) 
Distention/bloating, abdominal  1  0/37 (0.00%)  1/8 (12.50%) 
Dry mouth/salivary gland (xerostomia)  1  2/37 (5.41%)  0/8 (0.00%) 
Nausea  1  7/37 (18.92%)  1/8 (12.50%) 
Obstruction, GI - Small bowel NOS  1  0/37 (0.00%)  1/8 (12.50%) 
Pain - Abdomen NOS  1  0/37 (0.00%)  1/8 (12.50%) 
Vomiting  1  3/37 (8.11%)  2/8 (25.00%) 
General disorders     
Edema: limb  1  9/37 (24.32%)  2/8 (25.00%) 
Fatigue (asthenia, lethargy, malaise)  1  18/37 (48.65%)  5/8 (62.50%) 
Fever in absence of neutropenia, ANC lt1.0x10e9/L  1  3/37 (8.11%)  1/8 (12.50%) 
Pain - Pain NOS  1  2/37 (5.41%)  0/8 (0.00%) 
Rigors/chills  1  4/37 (10.81%)  0/8 (0.00%) 
Infections and infestations     
Inf (clin/microbio) w/Gr 3-4 neuts - Lung  1  5/37 (13.51%)  0/8 (0.00%) 
Investigations     
ALT, SGPT (serum glutamic pyruvic transaminase)  1  4/37 (10.81%)  0/8 (0.00%) 
AST, SGOT  1  6/37 (16.22%)  1/8 (12.50%) 
Alkaline phosphatase  1  2/37 (5.41%)  1/8 (12.50%) 
Bilirubin (hyperbilirubinemia)  1  9/37 (24.32%)  1/8 (12.50%) 
Creatinine  1  8/37 (21.62%)  1/8 (12.50%) 
Leukocytes (total WBC)  1  20/37 (54.05%)  5/8 (62.50%) 
Lymphopenia  1  2/37 (5.41%)  0/8 (0.00%) 
Neutrophils/granulocytes (ANC/AGC)  1  20/37 (54.05%)  5/8 (62.50%) 
Platelets  1  24/37 (64.86%)  5/8 (62.50%) 
Metabolism and nutrition disorders     
Albumin, serum-low (hypoalbuminemia)  1  8/37 (21.62%)  2/8 (25.00%) 
Anorexia  1  6/37 (16.22%)  2/8 (25.00%) 
Calcium, serum-low (hypocalcemia)  1  11/37 (29.73%)  2/8 (25.00%) 
Dehydration  1  2/37 (5.41%)  1/8 (12.50%) 
Glucose, serum-high (hyperglycemia)  1  15/37 (40.54%)  2/8 (25.00%) 
Magnesium, serum-low (hypomagnesemia)  1  4/37 (10.81%)  1/8 (12.50%) 
Phosphate, serum-low (hypophosphatemia)  1  0/37 (0.00%)  1/8 (12.50%) 
Potassium, serum-high (hyperkalemia)  1  0/37 (0.00%)  1/8 (12.50%) 
Potassium, serum-low (hypokalemia)  1  4/37 (10.81%)  1/8 (12.50%) 
Sodium, serum-low (hyponatremia)  1  7/37 (18.92%)  1/8 (12.50%) 
Musculoskeletal and connective tissue disorders     
Muscle weakness, not d/t neuropathy - Extrem-lower  1  0/37 (0.00%)  1/8 (12.50%) 
Muscle weakness, not d/t neuropathy - body/general  1  4/37 (10.81%)  1/8 (12.50%) 
Pain - Bone  1  0/37 (0.00%)  1/8 (12.50%) 
Pain - Extremity-limb  1  0/37 (0.00%)  1/8 (12.50%) 
Nervous system disorders     
Dizziness  1  2/37 (5.41%)  0/8 (0.00%) 
Neuropathy: motor  1  2/37 (5.41%)  0/8 (0.00%) 
Neuropathy: sensory  1  4/37 (10.81%)  0/8 (0.00%) 
Pain - Head/headache  1  3/37 (8.11%)  1/8 (12.50%) 
Taste alteration (dysgeusia)  1  2/37 (5.41%)  1/8 (12.50%) 
Psychiatric disorders     
Mood alteration - anxiety  1  4/37 (10.81%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  6/37 (16.22%)  0/8 (0.00%) 
Dyspnea (shortness of breath)  1  6/37 (16.22%)  0/8 (0.00%) 
Hemorrhage, pulmonary/upper respiratory - Nose  1  3/37 (8.11%)  1/8 (12.50%) 
Pleural effusion (non-malignant)  1  2/37 (5.41%)  0/8 (0.00%) 
Pneumonitis/pulmonary infiltrates  1  2/37 (5.41%)  0/8 (0.00%) 
Pulmonary/Upper Respiratory-Other (Specify)  1  2/37 (5.41%)  0/8 (0.00%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  2/37 (5.41%)  1/8 (12.50%) 
Induration/fibrosis (skin and subcutaneous tissue)  1  0/37 (0.00%)  1/8 (12.50%) 
Petechiae/purpura (hemorrhage into skin or mucosa)  1  4/37 (10.81%)  1/8 (12.50%) 
Pruritus/itching  1  7/37 (18.92%)  1/8 (12.50%) 
Rash/desquamation  1  9/37 (24.32%)  2/8 (25.00%) 
Vascular disorders     
Hematoma  1  0/37 (0.00%)  1/8 (12.50%) 
Hot flashes/flushes  1  0/37 (0.00%)  1/8 (12.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Study Statistician
Organization: SWOG
Phone: 206-667-4623
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00352365     History of Changes
Other Study ID Numbers: NCI-2009-00785
NCI-2009-00785 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SWOG-S0605
CDR0000484449
S0605 ( Other Identifier: Southwest Oncology Group )
S0605 ( Other Identifier: CTEP )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: July 13, 2006
First Posted: July 14, 2006
Results First Submitted: May 15, 2013
Results First Posted: July 4, 2013
Last Update Posted: July 31, 2014