Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 65 of 494 for:    LENALIDOMIDE AND every 28 days

Revlimid in Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00360672
Recruitment Status : Completed
First Posted : August 7, 2006
Results First Posted : August 1, 2013
Last Update Posted : August 14, 2013
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Intervention Drug: Revlimid
Enrollment 27
Recruitment Details Recruitment Period: 08/03/2006 through 05/10/2012. All participants recruited at UT MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title Revlimid
Hide Arm/Group Description Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
Period Title: Overall Study
Started 27
Completed 27
Not Completed 0
Arm/Group Title Revlimid
Hide Arm/Group Description Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 27 participants
64
(39 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
13
  48.1%
Male
14
  51.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants
27
1.Primary Outcome
Title Number of Participants With a Response (Complete Remissions (CR), Complete Remissions With Incomplete Platelet Recovery [CRp] and Partial Responses)
Hide Description Response for Acute Myeloid Leukemia (AML) according to 2003 International Working Group (IWG) criteria: CR required absolute neutrophil count (ANC) >1 * 10^9/L, platelet count ≥100 * 10^9/L, < 5% of blast cells in bone marrow. CRp: as above except platelet count <100 * 10^9/L. Partial remission: as CR except for presence of 5-25% marrow blasts and with a decrease of marrow blast at least 50%. Response for Myelodysplastic Syndrome (MDS) was defined based on the 2006 IWG criteria. All participants with MDS who achieved hematological CR, Partial Response (PR), marrow CR, and hematological improvement considered responders.
Time Frame Following three 28-day cycles evaluated for response
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Revlimid
Hide Arm/Group Description:
Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: participants
Complete Remission 1
Complete Remission Incomplete Platelet Recovery 1
Partial Remission 0
Time Frame 5 years, 8 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Revlimid
Hide Arm/Group Description Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
All-Cause Mortality
Revlimid
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Revlimid
Affected / at Risk (%) # Events
Total   9/27 (33.33%)    
Cardiac disorders   
Atrial Fibrillation  1  3/27 (11.11%)  6
Gastrointestinal disorders   
Vomit  1  1/27 (3.70%)  1
Hemorrhage  1  1/27 (3.70%)  1
General disorders   
Death  1  5/27 (18.52%)  5
Infections and infestations   
Infection  1  3/27 (11.11%)  3
Nervous system disorders   
Stroke  1  2/27 (7.41%)  3
Renal and urinary disorders   
Renal Failure  1  1/27 (3.70%)  1
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%
Revlimid
Affected / at Risk (%) # Events
Total   26/27 (96.30%)    
Blood and lymphatic system disorders   
Neutropenia  1  8/27 (29.63%)  8
Thrombocytopenia  1  14/27 (51.85%)  14
General disorders   
Fatigue  1  3/27 (11.11%)  3
Infections and infestations   
Neutropenic Fever  1  4/27 (14.81%)  4
Neutropenic Fever With Pneumonia  1  3/27 (11.11%)  3
Nonneutropenic Infection  1  13/27 (48.15%)  13
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: Gautam Borthakur, M.D./Associate Professor
Organization: UT MD Anderson Cancer Center
Phone: 713-563-1586
EMail: eharriso@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00360672     History of Changes
Other Study ID Numbers: 2006-0293
First Submitted: August 4, 2006
First Posted: August 7, 2006
Results First Submitted: May 31, 2013
Results First Posted: August 1, 2013
Last Update Posted: August 14, 2013