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Phase II Study of Fludarabine and Mitoxantrone, Followed by GM-CSF(Granulocyte-macrophage Colony-stimulating Factor) and Rituximab

This study has been terminated.
(slow accrual)
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Christopher R. Flowers, Emory University
ClinicalTrials.gov Identifier:
NCT00208975
First received: September 13, 2005
Last updated: May 25, 2012
Last verified: May 2012
Results First Received: March 16, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma
Intervention: Drug: Mitoxantrone/Cyclophosphamide, Fludarabine, Rituximab and GM-CSF

  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
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
Fludarabine and Cyclophosphamide With Sequential Administratio Patients will receive fludarabine and cyclophosphamide with sequential administration of GM-CSF on days 6 and 7 and rituximab on day 8.

Participant Flow:   Overall Study
    Fludarabine and Cyclophosphamide With Sequential Administratio  
STARTED     15  
COMPLETED     15  
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
Fludarabine and Cyclophosphamide With Sequential Administratio Patients will receive fludarabine and cyclophosphamide with sequential administration of GM-CSF on days 6 and 7 and rituximab on day 8.

Baseline Measures
    Fludarabine and Cyclophosphamide With Sequential Administratio  
Number of Participants  
[units: participants]
  15  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     9  
>=65 years     6  
Age  
[units: years]
Median ( Full Range )
  62  
  ( 45 to 81 )  
Gender  
[units: participants]
 
Female     4  
Male     11  
Region of Enrollment  
[units: participants]
 
United States     15  
Diagnosis Type  
[units: Participants]
 
Low Grade Non Hodgkin's Lymphoma(NHL)     7  
Chronic Lymphocytic Leukemia (CLL)     8  



  Outcome Measures

1.  Primary:   Number of Patients's Who Had Complete Response and Partial Response to the Treatment of Fludarabine and Cyclophosphamide Followed by GM-CSF and Rituximab.   [ Time Frame: 6 months ]


  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
The protocol was closed early due to slow and poor accrual.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Christopher Flowers
Organization: Emory University
phone: 404-778-3942
e-mail: crflowe@emory.edu


No publications provided


Responsible Party: Christopher R. Flowers, Emory University
ClinicalTrials.gov Identifier: NCT00208975     History of Changes
Other Study ID Numbers: 1048-2001
Study First Received: September 13, 2005
Results First Received: March 16, 2012
Last Updated: May 25, 2012
Health Authority: United States: Institutional Review Board