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Use of Ribavirin and Low Dose Ara-C to Treat Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Sarit Assouline, Jewish General Hospital
ClinicalTrials.gov Identifier:
NCT01056523
First received: January 25, 2010
Last updated: December 2, 2016
Last verified: December 2016
Results First Received: October 19, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Myeloid Leukemia
Interventions: Drug: Ribavirin
Drug: Cytarabine arabinoside

  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 in this dose escalation study according to a 3+3 design. Patients not completing 28 days of therapy were replaced as they were not evaluable for the pharmacokinetic endpoint of steady state level of ribavirin.

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
Dose Level 1 Ribavirin 1000 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
Dose Level 2 Ribavirin 1400 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
Dose Level 3 Ribavirin 1800 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
Dose Level 4 Ribavirin 2200 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
Dose Level 5 Ribavirin 1000 mg po bid x 28 days, cytarabine arabinoside 10 mg sc bid days 1 to 10
Dose Level 6 Ribavirin 1400 mg po bid x 28 days, cytarabine arabinoside 10 mg sc bid days 1 to 10
Dose Level 7 Ribavirin 1800 mg po bid x 28 days, cytarabine arabinoside 10 mg sc bid days 1 to 10

Participant Flow:   Overall Study
    Dose Level 1   Dose Level 2   Dose Level 3   Dose Level 4   Dose Level 5   Dose Level 6   Dose Level 7
STARTED   4   3   5   6   3   3   5 
COMPLETED   3   3   3   3   3   3   4 
NOT COMPLETED   1   0   2   3   0   0   1 
Death                1                0                2                3                0                0                1 



  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
Ribavirin and Cytarabine Dose level 1 = 1000 mg po BID/ Dose level 2 = 1400 mg po BID/ Dose level 3 = 1800 mg po BID Drug: Cytarabine arabinoside Previous cohorts at 20 mg bid days 1 to 10 of every 28 day cycle. Dosage modified to 10 mg bid days 1 to 10 of every 28 day cycle for more recent cohorts.

Baseline Measures
   Ribavirin and Cytarabine 
Overall Participants Analyzed 
[Units: Participants]
 29 
Age 
[Units: Years]
Median (Full Range)
 65 
 (22 to 83) 
Gender 
[Units: Participants]
Count of Participants
 
Female      14  48.3% 
Male      15  51.7% 
FAB subtype [1] 
[Units: Participants]
Count of Participants
 
FAB sutype M4/M5      22  75.9% 
Other FAB subtypes      7  24.1% 
[1] FAB - French American British leukemia classification


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Recommended Phase II Dose (RP2D) of Ribavirin When Given in Combination With Low-dose Ara-C   [ Time Frame: 56 days ]

2.  Secondary:   Overall Response Rate   [ Time Frame: 2-3 years ]

3.  Secondary:   Complete Response Rate   [ Time Frame: 2-3 years ]

4.  Secondary:   Partial Response   [ Time Frame: 2-3 years ]

5.  Secondary:   Blast Response   [ Time Frame: 2-3 years ]


  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
There were no limitations or caveats


  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: Dr. Assouline
Organization: Jewish General Hospital
phone: 514-340-8222 ext 8434
e-mail: sarit.assouline@mcgill.ca


Publications of Results:
Other Publications:

Responsible Party: Sarit Assouline, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT01056523     History of Changes
Other Study ID Numbers: Ribavirin-002
Study First Received: January 25, 2010
Results First Received: October 19, 2015
Last Updated: December 2, 2016