Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

LBH589 Plus Decitabine for Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00691938
First received: June 4, 2008
Last updated: August 18, 2016
Last verified: August 2016
Results First Received: August 18, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Interventions: Drug: LBH589
Drug: Decitabine

  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
The study opened to participant enrollment on 06/23/2008 and closed to participant enrollment on 11/06/2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Level 1

LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.

Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.

Level 2

LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.

Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.

Level 3

LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.

Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.

Level 4

LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.

Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.

Level 5

LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.

Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.

Level 5B

LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.

Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.

Phase II

LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B.

Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.


Participant Flow:   Overall Study
    Level 1   Level 2   Level 3   Level 4   Level 5   Level 5B   Phase II
STARTED   5   3   6   8   10   6   14 
COMPLETED   4   3   6   8   10   6   14 
NOT COMPLETED   1   0   0   0   0   0   0 
QTc prolongation                1                0                0                0                0                0                0 



  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.
No text entered.

Reporting Groups
  Description
Level 1

LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.

Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.

Level 2

LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.

Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.

Level 3

LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.

Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.

Level 4

LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.

Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.

Level 5

LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.

Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.

Level 5B

LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.

Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.

Phase II

LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B.

Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle.

Total Total of all reporting groups

Baseline Measures
   Level 1   Level 2   Level 3   Level 4   Level 5   Level 5B   Phase II   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   3   6   8   10   6   14   52 
Age 
[Units: Years]
Median (Full Range)
 69 
 (62 to 74) 
 69 
 (67 to 83) 
 68 
 (62 to 75) 
 72 
 (61 to 86) 
 73 
 (64 to 87) 
 71 
 (63 to 80) 
 66 
 (61 to 78) 
 70 
 (61 to 87) 
Gender 
[Units: Participants]
               
Female   3   1   3   3   2   5   10   27 
Male   2   2   3   5   8   1   4   25 
Region of Enrollment 
[Units: Participants]
               
United States   5   3   6   8   10   6   14   52 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Phase I: Maximum Tolerated Dose (MTD) of LBH589 When Given in Combination With Decitabine   [ Time Frame: Completion of Phase I enrollment for MTD (approximately 26 months) ]

2.  Primary:   Phase II: Overall Rate of Morphologic Complete Remission (CR) + Cytogenetic Complete Remission (CRc) + Morphologic Complete Remission With Incomplete Blood Count Recovery (CRi)   [ Time Frame: Up to 12 months ]

3.  Secondary:   Rate of Cytogenetic Complete Remission (CRc)   [ Time Frame: Up to 12 months ]

4.  Secondary:   Changes in Quality of Life Scores as Measured by the Function Assessment of Cancer Therapy-Leukemia (FACT-Leu) Version 4   [ Time Frame: Up to approximately 12 months after start of treatment ]

5.  Secondary:   Time to Response   [ Time Frame: Up to 12 months ]

6.  Secondary:   Safety and Tolerability of Regimen as Measured by the Rate of the Most Common Adverse Events Experienced   [ Time Frame: Up to 13 months after start of treatment ]

7.  Secondary:   Remission Duration   [ Time Frame: Completion of follow-up (median follow-up was 58 months) ]

8.  Secondary:   Progression-free Survival   [ Time Frame: Completion of follow-up (median follow-up was 58 months) ]

9.  Secondary:   Event-free Survival   [ Time Frame: Completion of follow-up (median follow-up was 58 months) ]

10.  Secondary:   Overall Survival   [ Time Frame: Completion of follow-up (median follow-up was 58 months) ]

11.  Secondary:   Rates of Morphologic Complete Remission With Incomplete Count Recovery (CRi)   [ Time Frame: Up to 12 months ]

12.  Secondary:   Rate of Hematologic Improvement.   [ Time Frame: Up to 12 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: Geoffrey Uy, M.D.
Organization: Washington University School of Medicine
phone: 314-454-8304
e-mail: guy@wustl.edu


Publications:
Cashen, A., G. J. Schiller, et al. (2006). Phase II Study of Low-Dose Decitabine for the Front-Line Treatment of Older Patients with Acute Myeloid Leukemia (AML). ASH Annual Meeting Abstracts 108(11): 1984.


Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00691938     History of Changes
Other Study ID Numbers: 08-0172 / 201012979
Study First Received: June 4, 2008
Results First Received: August 18, 2016
Last Updated: August 18, 2016
Health Authority: United States: Food and Drug Administration