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3-AP and Fludarabine in Treating Patients With Myeloproliferative Disorders, Chronic Myelomonocytic Leukemia, or Accelerated Phase or Blastic Phase Chronic Myelogenous Leukemia

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ClinicalTrials.gov Identifier: NCT00381550
Recruitment Status : Completed
First Posted : September 28, 2006
Results First Posted : May 21, 2014
Last Update Posted : January 6, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Accelerated Phase Chronic Myelogenous Leukemia
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Blastic Phase Chronic Myelogenous Leukemia
Chronic Eosinophilic Leukemia
Chronic Myelomonocytic Leukemia
Essential Thrombocythemia
Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
Polycythemia Vera
Primary Myelofibrosis
Relapsing Chronic Myelogenous Leukemia
Interventions: Drug: fludarabine phosphate
Drug: triapine
Procedure: laboratory biomarker analysis

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patient's presenting for treatment of a myeloproliferative disease were considered for participation.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Once patient consented to treatment, treatment began shortly there after.

Reporting Groups
  Description
Triapine and Fludarabine Phosphate Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Triapine and Fludarabine Phosphate
STARTED   35 
COMPLETED   35 
NOT COMPLETED   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
Arm I Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Baseline Measures
   Arm I 
Overall Participants Analyzed 
[Units: Participants]
 35 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   17 
>=65 years   18 
Age 
[Units: Years]
Mean (Standard Deviation)
 65  (40) 
Gender 
[Units: Participants]
 
Female   18 
Male   17 
Region of Enrollment 
[Units: Participants]
 
United States   35 


  Outcome Measures

1.  Primary:   Response Rate Including Complete Response, Partial Response, and Hematological Improvement Assessed by Blood Cell Counts, Number of Blasts in Bone Marrow, and Clinical Evaluation   [ Time Frame: Up to 4 years ]

2.  Primary:   Incidence of Grade 3 or 4 Drug-related Non-hematologic Toxicity as Assessed by NCI CTCAE v3.0   [ Time Frame: Up to 4 years ]


  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 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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Michael McDevitt, MD PhD
Organization: Sidney Kimmel Comprehensive Cancer Center
phone: 410-955-9175
e-mail: mmcdev1@jhmi.edu


Publications of Results:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00381550     History of Changes
Other Study ID Numbers: NCI-2009-00209
NCI-2009-00209 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
J0638 ( Other Identifier: Johns Hopkins University/Sidney Kimmel Cancer Center )
7704 ( Other Identifier: CTEP )
P30CA006973 ( U.S. NIH Grant/Contract )
U01CA070095 ( U.S. NIH Grant/Contract )
First Submitted: September 26, 2006
First Posted: September 28, 2006
Results First Submitted: April 23, 2014
Results First Posted: May 21, 2014
Last Update Posted: January 6, 2015