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Trial record 12 of 441 for:    "Juvenile myelomonocytic leukemia"

Low-dose Oral Clofarabine for the Treatment of IPSS INT-1, INT-2 or HIGH Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00708721
Recruitment Status : Terminated (Data analysis revealed sufficient data for safety and efficacy)
First Posted : July 2, 2008
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
University of Utah

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cancer
Chronic Myelomonocytic Leukemia
Intervention: Drug: Clofarabine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Cohort 1: 5 mg/Day for 10 Days 5 mg/day for 10 out of 28 days
Cohort 2: 1 mg/Day for 10 Days 1 mg/day for 10/28 days and for cycle 1 and then 1 mg/day for 7/28 days for cycle 2 onward
Cohort 3: 1 mg/Day for 7 Days 1 mg/day for 7/28 days
Not Evaluable No text entered.

Participant Flow:   Overall Study
    Cohort 1: 5 mg/Day for 10 Days   Cohort 2: 1 mg/Day for 10 Days   Cohort 3: 1 mg/Day for 7 Days   Not Evaluable
STARTED   2   4   3   2 
COMPLETED   2   4   3   2 
NOT COMPLETED   0   0   0   0 



  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
All Groups No text entered.

Baseline Measures
   All Groups 
Overall Participants Analyzed 
[Units: Participants]
 11 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      4  36.4% 
>=65 years      7  63.6% 
Age 
[Units: Years]
Mean (Full Range)
 68.3 
 (59 to 81) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  45.5% 
Male      6  54.5% 
Region of Enrollment 
[Units: Participants]
 
United States   11 


  Outcome Measures

1.  Primary:   Number of Participants Who Experienced a Dose-Limiting Toxicity   [ Time Frame: 28 days after the first admistration of oral clofarabine ]

2.  Primary:   The Overall Response Rate in Response to Low Dose Daily Oral Clofarabine in Patients With High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia (Dysplastic Type).   [ Time Frame: 4 weeks ]

3.  Secondary:   Time to Progression to Acute Myeloid Leukemia (AML)   [ Time Frame: approximately 4 years ]

4.  Secondary:   Response of MDS Patients Treated With Low Dose Daily Oral Clofarabine.   [ Time Frame: approximately 4 years ]

5.  Secondary:   The Effect of Low Dose Daily Oral Clofarabine on Global Methylation in Patients With MDS.   [ Time Frame: through end of treatment ]

6.  Secondary:   The Effect of Low Dose Daily Oral Clofarabine on miRNA and mRNA Expression Patterns in Patients With MDS   [ Time Frame: through end of treatment ]

7.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: To 30 days after end of treatment or until full resolution. ]


  Serious Adverse Events


  Other Adverse Events


  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

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: Dr. Paul Shami
Organization: Huntsman Cancer Institute
phone: 801-585-0100
e-mail: paul.shami@hci.utah.edu



Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00708721     History of Changes
Other Study ID Numbers: HCI26135
First Submitted: June 27, 2008
First Posted: July 2, 2008
Results First Submitted: July 21, 2016
Results First Posted: June 1, 2017
Last Update Posted: June 1, 2017