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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:
ClinicalTrials.gov Identifier:
NCT00208975
First Posted: September 21, 2005
Last Update Posted: June 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bayer
Information provided by (Responsible Party):
Christopher R. Flowers, Emory University
Results First Submitted: March 16, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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 
Overall Participants Analyzed 
[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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Christopher R. Flowers, Emory University
ClinicalTrials.gov Identifier: NCT00208975     History of Changes
Other Study ID Numbers: 1048-2001
First Submitted: September 13, 2005
First Posted: September 21, 2005
Results First Submitted: March 16, 2012
Results First Posted: June 28, 2012
Last Update Posted: June 28, 2012