Study of Temozolomide in Previously Untreated Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Participants With Low O6-Methylguanine Methyltransferase (MGMT) Expression (P05052) (TALL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00687323
First received: May 27, 2008
Last updated: June 16, 2014
Last verified: June 2014
Results First Received: May 4, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia, Acute Myeloid
Myelodysplastic Syndrome
Intervention: Drug: temozolomide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Temozolomide Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).

Participant Flow:   Overall Study
    Temozolomide  
STARTED     195 [1]
Received Treatment     47  
COMPLETED     15 [2]
NOT COMPLETED     180  
Death                 25  
Withdrawal by Subject                 1  
Excluded from efficacy evaluations                 6  
Screen failure                 148  
[1] Number of screened participants
[2] Number of participants alive at one year



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Temozolomide Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).

Baseline Measures
    Temozolomide  
Number of Participants  
[units: participants]
  47  
Age [1]
[units: years]
Mean ( Full Range )
  75  
  ( 52 to 89 )  
Gender [1]
[units: participants]
 
Female     18  
Male     29  
Region of Enrollment [1]
[units: participants]
 
Canada     47  
[1] Number of participants who received treatment



  Outcome Measures
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1.  Primary:   Clinical Response at the End of Temozolomide Induction   [ Time Frame: at the end of each cycle (approximately 4 weeks post start of cycle), up to a maximum 63 weeks ]

2.  Secondary:   Duration of Response in Participants Achieving Complete Response (CR) and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide   [ Time Frame: Up to 1 year after treatment ends (up to 115 weeks) ]

3.  Secondary:   Relapse-free Survival in Participants Achieving CR or CRp and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide   [ Time Frame: Start of treatment until disease progression [up to 1 year after treatment ends (up to 115 weeks)] ]

4.  Secondary:   Overall Survival (OS) in Participants Achieving CR or CRp and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide   [ Time Frame: Start of treatment until death or end of study [up to 1 year after treatment ends (up to 115 weeks)] ]

5.  Secondary:   Number of Previously Untreated Participants With Low O6-Methylguanine Methyltransferase (MGMT) Expression   [ Time Frame: Baseline ]

6.  Secondary:   MGMT Expression in Leukemic Blasts at the Time of Relapse   [ Time Frame: Up to 1 year after treatment ends (up to 115 weeks) ]

7.  Secondary:   Number of Participants With CR, PR, or MLFS Who Received Modified Low Dose Maintenance Therapy (100 mg/m^2/Day x21 Days of Each 28 Day Cycle) and Experienced Toxicity   [ Time Frame: From first dose to 30 days after last dose of study drug (up to 67 weeks) ]

8.  Secondary:   Progression-free Survival for Participants Achieving PR, MLSF, or MR   [ Time Frame: Start of treatment until disease progression [up to 1 year after treatment ends (up to 115 weeks)] ]

9.  Secondary:   Quality of Life (QoL) in Participants Receiving Long Term Temozolomide Therapy Assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-30   [ Time Frame: Baseline and post-study visit (63 weeks) ]

10.  Secondary:   Quality of Life (QoL) in Participants Receiving Long Term Temozolomide Therapy Assessed by EORTC QLQ-LC13   [ Time Frame: Baseline and post-study visit (63 weeks) ]

11.  Secondary:   Quality of Life (QoL) in Participants Receiving Long Term Temozolomide Therapy Assessed by Functional Assessment of Cancer Therapy (FACT)-G   [ Time Frame: Baseline and post-study visit (63 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00687323     History of Changes
Other Study ID Numbers: P05052, MK-7365-240
Study First Received: May 27, 2008
Results First Received: May 4, 2012
Last Updated: June 16, 2014
Health Authority: Canada: Health Canada