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Fludarabine, Cyclophosphamide, and Rituximab Versus Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-Cell Chronic Lymphocytic Leukemia Patients

This study has been completed.
Sponsor:
Collaborator:
Astex Pharmaceuticals
Information provided by (Responsible Party):
US Oncology Research
ClinicalTrials.gov Identifier:
NCT00254163
First received: November 9, 2005
Last updated: September 15, 2016
Last verified: September 2016
Results First Received: February 2, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: B-Cell Chronic Lymphocytic Leukemia
Interventions: Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Rituximab
Drug: Pentostatin

  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
FCR Arm Fludarabine, Cyclophosphamide, and Rituximab
PCR Arm Pentostatin, Cyclophosphamide, and Rituximab

Participant Flow:   Overall Study
    FCR Arm   PCR Arm
STARTED   92   92 
COMPLETED   47   46 
NOT COMPLETED   45   46 
Adverse Event                29                26 
Patient request/withdrew consent                6                4 
Investigator request                1                3 
Failed entry                1                3 
Progressive disease                0                1 
Death                0                1 
Other                8                8 



  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.
ITT population

Reporting Groups
  Description
FCR Arm Fludarabine, Cyclophosphamide, and Rituximab
PCR Arm Pentostatin, Cyclophosphamide, and Rituximab
Total Total of all reporting groups

Baseline Measures
   FCR Arm   PCR Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 92   92   184 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.3  (10.2)   63.6  (9.9)   63.5  (10.0) 
Gender 
[Units: Participants]
     
Female   27   22   49 
Male   65   70   135 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasion   81   84   165 
Black   7   5   12 
Hispanic   2   3   5 
Mixed: Black/Indian   2   0   2 
Region of Enrollment 
[Units: Participants]
     
United States   92   92   184 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Infection Rate   [ Time Frame: 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity ]

2.  Secondary:   Infective Event Rate   [ Time Frame: 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity ]

3.  Secondary:   Percentage of Patients Hospitalized   [ Time Frame: 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity ]

4.  Secondary:   Hematologic Recovery   [ Time Frame: 2 months post-treatment ]

5.  Secondary:   Mean Absolute Neutrophil Count (ANC) at Post-treatment   [ Time Frame: 2 months post-treatment ]

6.  Secondary:   Complete Remission (CR)   [ Time Frame: 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity ]

7.  Secondary:   Objective Remission Rate (ORR)   [ Time Frame: 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity ]

8.  Secondary:   Progression-free Survival (PFS) Rate at 1-year   [ Time Frame: 12 months after registered. ]

9.  Secondary:   Progression-free Survival (PFS) Rate at 2-year   [ Time Frame: 24 months after registered. ]


  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
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  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. Craig Reynolds
Organization: Ocala Oncology
phone: (352) 732-4032
e-mail: Craig.Reynolds@USOncology.com



Responsible Party: US Oncology Research
ClinicalTrials.gov Identifier: NCT00254163     History of Changes
Other Study ID Numbers: 03017
NIP-03-007 ( Other Identifier: Hospira )
Study First Received: November 9, 2005
Results First Received: February 2, 2016
Last Updated: September 15, 2016