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

Arsenic Trioxide and Gemtuzumab Ozogamicin in Treating Patients With Advanced Myelodysplastic Syndromes

This study has been completed.
Sponsor:
Collaborators:
University of Michigan
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00274781
First received: January 10, 2006
Last updated: July 6, 2015
Last verified: July 2015
Results First Received: June 3, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia
Myelodysplastic Syndromes
Interventions: Drug: arsenic trioxide
Drug: gemtuzumab ozogamicin

  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
Patients were enrolled at Cleveland Clinic and the University of Michigan from February 2004 through June 2006.

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
ATO (0.25mg/kg) and GO (3mg/m2) ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.

Participant Flow:   Overall Study
    ATO (0.25mg/kg) and GO (3mg/m2)  
STARTED     30  
COMPLETED     30  
NOT COMPLETED     0  



  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.
No text entered.

Reporting Groups
  Description
ATO (0.25mg/kg) and GO (3mg/m2) ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.

Baseline Measures
    ATO (0.25mg/kg) and GO (3mg/m2)  
Number of Participants  
[units: participants]
  30  
Age  
[units: years]
Median (Full Range)
  69  
  (44 to 88)  
Gender  
[units: participants]
 
Female     9  
Male     21  
Region of Enrollment  
[units: participants]
 
United States     30  



  Outcome Measures
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1.  Primary:   Complete and Partial Remission Per the International Working Group (IWG) Criteria for Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML)   [ Time Frame: at 12 weeks post treatment ]

2.  Secondary:   Overall Survival   [ Time Frame: From date of enrollment to a minimum of three years for survival ]

3.  Secondary:   Tolerability   [ Time Frame: 12 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 NOT 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.


Results Point of Contact:  
Name/Title: Mikkael Sekeres, MD, MS
Organization: The Cleveland Clinic
phone: 216-445-9353
e-mail: sekerem@ccf.org



Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00274781     History of Changes
Other Study ID Numbers: CCF6818
P30CA043703 ( US NIH Grant/Contract Award Number )
CCF-6818 ( Other Identifier: Cleveland Clinic IRB )
Study First Received: January 10, 2006
Results First Received: June 3, 2015
Last Updated: July 6, 2015
Health Authority: United States: Food and Drug Administration