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Trial record 4 of 52 for:    LENALIDOMIDE AND Leukemia AND Acute Myeloid Leukemia (AML)

Phase 1-2 of Azacitidine + Lenalidomide for Previously Untreated Elderly Patients With Acute Myeloid Leukemia (AML)

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ClinicalTrials.gov Identifier: NCT00890929
Recruitment Status : Completed
First Posted : April 30, 2009
Results First Posted : October 20, 2014
Last Update Posted : June 18, 2018
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Bruno C. Medeiros, Stanford University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Myeloid Leukemia (AML)
Adult Acute Myeloblastic Leukemia
Interventions Drug: Lenalidomide
Drug: Azacitidine
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Azacitidine Followed by Lenalidomide
Hide Arm/Group Description

Dose escalation then dose expansion

Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle

Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle

Period Title: Overall Study
Started 45
Consented & Enrolled 45
Initiated Treatment 43
Completed 39
Not Completed 6
Reason Not Completed
Death before treatment             2
Withdrawal by Subject             3
Physician Decision             1
Arm/Group Title Azacitidine Followed by Lenalidomide
Hide Arm/Group Description

Dose escalation then dose expansion

Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle

Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle

Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 45 participants
74
(62 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
17
  37.8%
Male
28
  62.2%
1.Primary Outcome
Title Compete Remission (CR) Rate
Hide Description Compete Remission (CR) includes subjects with CR but incomplete recovery of blood counts (CRi). CR was assessed according to the European LeukemiaNet (ELN) guidelines, and is defined as the absence of clonal lymphocytes in the peripheral blood.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azacitidine Followed by Lenalidomide
Hide Arm/Group Description:

Dose escalation then dose expansion

Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle

Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle

Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of subjects
28
2.Secondary Outcome
Title 4-week Survival Rate
Hide Description "Early death" was assessed as death within 28 days of the start of treatment
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azacitidine Followed by Lenalidomide
Hide Arm/Group Description:

Dose escalation then dose expansion

Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle

Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle

Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of subjects remaining alive
83
3.Secondary Outcome
Title Maximum Tolerated Dose (MTD) of Lenalidomide
Hide Description The maximum tolerated dose (MTD) of lenalidomide was determined in study phase 1, for use in study Phase 2 (not conducted). The outcome is reported as the dose of lenalidomide that represents the MTD.
Time Frame 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome only includes results from participants in study Phase 1.
Arm/Group Title Azacitidine Followed by Lenalidomide
Hide Arm/Group Description:

Dose escalation then dose expansion

Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle

Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle

Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: mg/day lenalidomide (oral)
50
4.Secondary Outcome
Title Remission Duration
Hide Description Responses and remission were assessed according to the ELN guidelines.
Time Frame 26 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azacitidine Followed by Lenalidomide
Hide Arm/Group Description:

Dose escalation then dose expansion

Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle

Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle

Overall Number of Participants Analyzed 43
Median (Full Range)
Unit of Measure: weeks
6
(6 to 104)
5.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description ORR includes subjects with CR, CRi, and partial response (PR). Responses were assessed according to the ELN guidelines.
Time Frame 26 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azacitidine Followed by Lenalidomide
Hide Arm/Group Description:

Dose escalation then dose expansion

Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle

Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle

Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of subjects
41
6.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS from the start of treatment was assessed at a median follow up of 88 weeks from the end of treatment (range, 1-120), and was censored at 1 April 2012.
Time Frame 88 weeks (median)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azacitidine Followed by Lenalidomide
Hide Arm/Group Description:

Dose escalation then dose expansion

Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle

Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle

Overall Number of Participants Analyzed 43
Median (Full Range)
Unit of Measure: weeks
20
(10 to 121)
7.Secondary Outcome
Title Time to CR
Hide Description CR includes subjects with CR but incomplete recovery of blood counts (CRi). Responses were assessed according to the ELN guidelines.
Time Frame 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azacitidine Followed by Lenalidomide
Hide Arm/Group Description:

Dose escalation then dose expansion

Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle

Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle

Overall Number of Participants Analyzed 43
Median (Full Range)
Unit of Measure: weeks
12
(6 to 18)
8.Secondary Outcome
Title Time to PR
Hide Description Responses were assessed according to the ELN guidelines.
Time Frame 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azacitidine Followed by Lenalidomide
Hide Arm/Group Description:

Dose escalation then dose expansion

Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle

Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle

Overall Number of Participants Analyzed 43
Median (Full Range)
Unit of Measure: weeks
6
(6 to 36)
9.Secondary Outcome
Title OS of Responders
Hide Description OS from the start of treatment of responders (per ELN guidelines) was assessed at a median follow up of 88 weeks from the end of treatment (range, 1-120), and was censored at 1 April 2012.
Time Frame 88 weeks (median)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azacitidine Followed by Lenalidomide
Hide Arm/Group Description:

Dose escalation then dose expansion

Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle

Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle

Overall Number of Participants Analyzed 43
Median (Full Range)
Unit of Measure: weeks
69
(10 to 121)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Azacitidine Followed by Lenalidomide
Hide Arm/Group Description

Dose escalation then dose expansion

Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle

Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle

All-Cause Mortality
Azacitidine Followed by Lenalidomide
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Azacitidine Followed by Lenalidomide
Affected / at Risk (%) # Events
Total   36/43 (83.72%)    
Blood and lymphatic system disorders   
Febrile neutropenia * 1  24/43 (55.81%)  37
Blood and lymphatic system disorders - Other, Pancytopenia * 1  1/43 (2.33%)  1
Hemolysis * 1  1/43 (2.33%)  1
Cardiac disorders   
Atrial fibrillation * 1  1/43 (2.33%)  1
Cardiac disorders - Cardiac arrest * 1  1/43 (2.33%)  1
Pericarditis * 1  1/43 (2.33%)  1
Ear and labyrinth disorders   
External ear inflammation * 1  1/43 (2.33%)  1
Gastrointestinal disorders   
Colitis * 1  1/43 (2.33%)  1
Intra-abdominal hemorrhage * 1  1/43 (2.33%)  1
Upper gastrointestinal hemorrhage * 1  1/43 (2.33%)  1
Abdominal pain * 1  1/43 (2.33%)  1
General disorders   
Death NOS-AML disease * 1  2/43 (4.65%)  2
Death NOS-Cardiopulmonary arrest * 1  2/43 (4.65%)  2
Death NOS-Chills * 1  1/43 (2.33%)  1
Death NOS-Death * 1  2/43 (4.65%)  2
Death NOS- Thrombocytopenia * 1  1/43 (2.33%)  1
Death NOS-Disease progression * 1  3/43 (6.98%)  3
Death NOS-Hypoxia * 1  1/43 (2.33%)  1
Death NOS-pneumonia * 1  1/43 (2.33%)  1
Death NOS-Sepis * 1  1/43 (2.33%)  1
Death NOS-Terminal Ventricular Tachycardia * 1  1/43 (2.33%)  1
Fatigue * 1  1/43 (2.33%)  1
Fever * 1  2/43 (4.65%)  2
Non-cardiac chest pain * 1  1/43 (2.33%)  1
Infections and infestations   
Sepsis * 1  2/43 (4.65%)  2
Infections and infestations - Other, Neutropenia * 1  1/43 (2.33%)  1
Urinary tract infection * 1  1/43 (2.33%)  1
Investigations   
Platelet count decreased * 1  2/43 (4.65%)  2
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/43 (2.33%)  1
Bone pain * 1  1/43 (2.33%)  1
Generalized muscle weakness * 1  1/43 (2.33%)  2
Nervous system disorders   
Nervous system disorders - Other, high-grade glioblastoma (brain mass) * 1  1/43 (2.33%)  1
Ischemia cerebrovascular-Acute Stroke * 1  1/43 (2.33%)  1
Psychiatric disorders   
Anxiety * 1  1/43 (2.33%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  4/43 (9.30%)  4
Respiratory, thoracic and mediastinal disorders - Other, Pneumonia * 1  1/43 (2.33%)  1
Respiratory, thoracic and mediastinal disorders - Other, Respiratory failure * 1  2/43 (4.65%)  2
Bronchopulmonary hemorrhage * 1  1/43 (2.33%)  1
Epistaxis * 1  1/43 (2.33%)  1
Vascular disorders   
Hypotension * 1  1/43 (2.33%)  1
Vascular disorders - Other, Dieulafoy's lesion * 1  1/43 (2.33%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAEv4
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Azacitidine Followed by Lenalidomide
Affected / at Risk (%) # Events
Total   39/43 (90.70%)    
Cardiac disorders   
Atrial fibrillation * 1  5/43 (11.63%)  5
Cardiac disorders - other-Systolic Murmur * 1  3/43 (6.98%)  3
Gastrointestinal disorders   
Constipation * 1  20/43 (46.51%)  33
Diarrhea * 1  16/43 (37.21%)  30
Dry mouth * 1  4/43 (9.30%)  6
Dysphagia * 1  4/43 (9.30%)  8
Hemorrhoids * 1  4/43 (9.30%)  4
Mucositis oral * 1  9/43 (20.93%)  15
Nausea * 1  23/43 (53.49%)  50
Vomiting * 1  9/43 (20.93%)  18
General disorders   
Edema limbs * 1  15/43 (34.88%)  23
Fatigue * 1  16/43 (37.21%)  20
Fever * 1  6/43 (13.95%)  9
Injection site reaction * 1  18/43 (41.86%)  38
Infections and infestations   
Urinary tract infection * 1  5/43 (11.63%)  6
Infections and infestations -- other, Penumonia * 1  6/43 (13.95%)  6
Injury, poisoning and procedural complications   
Bruising * 1  4/43 (9.30%)  4
Investigations   
Blood bilirubin increased * 1  4/43 (9.30%)  4
Creatinine increased * 1  5/43 (11.63%)  5
Neutrophil count decreased * 1  3/43 (6.98%)  3
Metabolism and nutrition disorders   
Anorexia * 1  5/43 (11.63%)  6
Musculoskeletal and connective tissue disorders   
Back pain * 1  5/43 (11.63%)  6
Pain in extremity * 1  3/43 (6.98%)  4
Nervous system disorders   
Cognitive disturbance * 1  3/43 (6.98%)  4
Dizziness * 1  5/43 (11.63%)  6
Dysgeusia * 1  3/43 (6.98%)  3
Headache * 1  3/43 (6.98%)  3
Syncope * 1  3/43 (6.98%)  3
Tremor * 1  5/43 (11.63%)  6
Renal and urinary disorders   
Acute kidney injury * 1  6/43 (13.95%)  7
Urinary retention * 1  4/43 (9.30%)  5
Respiratory, thoracic and mediastinal disorders   
Cough * 1  14/43 (32.56%)  18
Dyspnea * 1  9/43 (20.93%)  13
Epistaxis * 1  7/43 (16.28%)  7
Pneumonitis * 1  3/43 (6.98%)  3
Sinus disorder * 1  3/43 (6.98%)  3
Voice alteration * 1  3/43 (6.98%)  4
Skin and subcutaneous tissue disorders   
Hyperhidrosis * 1  4/43 (9.30%)  6
Pruritus * 1  9/43 (20.93%)  15
Rash acneiform * 1  3/43 (6.98%)  3
Rash maculo-papular * 1  11/43 (25.58%)  17
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAEv4
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bruno C Medeiros, MD
Organization: Stanford University Medical Center
Phone: 650-498-6000
EMail: bruno.medeiros@stanford.edu
Layout table for additonal information
Responsible Party: Bruno C. Medeiros, Stanford University
ClinicalTrials.gov Identifier: NCT00890929     History of Changes
Other Study ID Numbers: IRB-15611
SU-04242009-2385 ( Other Identifier: Stanford University )
RV-AML-0410 ( Other Identifier: Celgene Corporation )
HEMAML0011 ( Other Identifier: OnCore )
First Submitted: April 28, 2009
First Posted: April 30, 2009
Results First Submitted: October 13, 2014
Results First Posted: October 20, 2014
Last Update Posted: June 18, 2018