Try our beta test site

5-Azacytidine With Lenalidomide in Patients With High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)

This study has been completed.
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01038635
First received: December 23, 2009
Last updated: December 19, 2016
Last verified: December 2016
Results First Received: December 19, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia
Interventions: Drug: 5-Azacytidine
Drug: Lenalidomide

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: December 23, 2009 to June 21, 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 94 participants registered, six were ineligible therefore not assigned to groups nor treated.

Reporting Groups
  Description
5-AZA + LEN 10 mg Phase I: 5-Azacytidine (5-AZA) + Lenalidomide (LEN): 5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10.
5-AZA + LEN 15 mg 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
5-AZA + LEN 20 mg 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
5-AZA + LEN 25 mg 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
5-AZA + LEN 50 mg 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
5-AZA + LEN 75 mg for 5 Days 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
5-AZA + LEN 75 mg for 10 Days 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
Phase II: AZA + LEN 50 mg 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.
Phase II: AZA+ LEN 25 mg 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.

Participant Flow:   Overall Study
    5-AZA + LEN 10 mg   5-AZA + LEN 15 mg   5-AZA + LEN 20 mg   5-AZA + LEN 25 mg   5-AZA + LEN 50 mg   5-AZA + LEN 75 mg for 5 Days   5-AZA + LEN 75 mg for 10 Days   Phase II: AZA + LEN 50 mg   Phase II: AZA+ LEN 25 mg
STARTED   5   3   3   3   4   3   7   20   40 
COMPLETED   3   3   3   3   3   3   5   15   38 
NOT COMPLETED   2   0   0   0   1   0   2   5   2 
Disease Progression                2                0                0                0                0                0                1                4                0 
Death                0                0                0                0                1                0                1                1                2 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics represented in study phase, Phase I and Phase II separately.

Reporting Groups
  Description
5-AZA + LEN 10 mg 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days
5-AZA + LEN 15 mg 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days
5-AZA + LEN 20 mg 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
5-AZA + LEN 25 mg 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
5-AZA + 50 LEN 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
5-AZA + LEN 75 mg 5 Days 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
5-AZA + LEN 75 mg for 10 Days 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
Phase II: 5-AZA + LEN 50 mg 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.
Phase II: AZA+ LEN 25 mg 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
Total Total of all reporting groups

Baseline Measures
   5-AZA + LEN 10 mg   5-AZA + LEN 15 mg   5-AZA + LEN 20 mg   5-AZA + LEN 25 mg   5-AZA + 50 LEN   5-AZA + LEN 75 mg 5 Days   5-AZA + LEN 75 mg for 10 Days   Phase II: 5-AZA + LEN 50 mg   Phase II: AZA+ LEN 25 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   3   3   3   4   3   7   20   40   88 
Age 
[Units: Years]
Median (Full Range)
 65 
 (55 to 79) 
 54 
 (54 to 66) 
 66 
 (65 to 69) 
 66 
 (54 to 71) 
 71 
 (65 to 79) 
 64 
 (63 to 77) 
 63 
 (32 to 70) 
 72 
 (36 to 88) 
 66 
 (38 to 85) 
 67 
 (32 to 88) 
Gender 
[Units: Participants]
Count of Participants
                   
Female      1  20.0%      1  33.3%      3 100.0%      2  66.7%      2  50.0%      2  66.7%      4  57.1%      9  45.0%      16  40.0%      40  45.5% 
Male      4  80.0%      2  66.7%      0   0.0%      1  33.3%      2  50.0%      1  33.3%      3  42.9%      11  55.0%      24  60.0%      48  54.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
                   
Hispanic or Latino      1  20.0%      0   0.0%      0   0.0%      1  33.3%      0   0.0%      0   0.0%      0   0.0%      2  10.0%      0   0.0%      4   4.5% 
Not Hispanic or Latino      4  80.0%      3 100.0%      3 100.0%      2  66.7%      4 100.0%      3 100.0%      6  85.7%      18  90.0%      37  92.5%      80  90.9% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1  14.3%      0   0.0%      3   7.5%      4   4.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
                   
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      1  33.3%      0   0.0%      0   0.0%      0   0.0%      1  33.3%      1  14.3%      2  10.0%      1   2.5%      6   6.8% 
White      5 100.0%      2  66.7%      3 100.0%      3 100.0%      4 100.0%      2  66.7%      5  71.4%      18  90.0%      36  90.0%      78  88.6% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1  14.3%      0   0.0%      3   7.5%      4   4.5% 
Region of Enrollment 
[Units: Participants]
                   
United States   5   3   3   3   4   3   7   20   40   88 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Dose Limiting Toxicities for Determining Maximum Tolerated Dose (MTD) of Lenalidomide in Combination With 5-azacytidine (5-AZA)   [ Time Frame: 3-8 week cycles, up to 24 weeks ]

2.  Secondary:   Overall Response Rate (ORR) of Lenalidomide in Combination With 5-azacytidine (5-AZA) in Participants With Leukemia   [ Time Frame: 6 months ]

3.  Secondary:   Overall Response: Number of Participants With CR or CRi Response   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Guillermo Garcia-Manero, MD/Professor, Leukemia
Organization: The University of Texas (UT) MD Anderson Cancer Center
phone: 713-792-7734
e-mail: CR_Study_Registration@mdanderson.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01038635     History of Changes
Other Study ID Numbers: 2009-0467
NCI-2011-01941 ( Registry Identifier: NCI CTRP )
Study First Received: December 23, 2009
Results First Received: December 19, 2016
Last Updated: December 19, 2016