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A Study of MabThera/Rituxan (Rituximab) in Combination With Fludarabine And Cyclophosphamide as Primary Therapy in Elderly Patients With Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT01263704
Recruitment Status : Completed
First Posted : December 21, 2010
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lymphocytic Leukemia, Chronic
Interventions: Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Rituximab

  Participant Flow

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
Rituximab Plus Fludarabine and Cyclophosphamide Elderly participants with chronic lymphocytic leukemia (CLL) received combination treatment with low-dose fludarabine and cyclophosphamide combined with standard-dose of rituximab for 6 months. Treatment was followed by a follow up period of 36 months.

Participant Flow:   Overall Study
    Rituximab Plus Fludarabine and Cyclophosphamide
STARTED   42 
COMPLETED   13 
NOT COMPLETED   29 
Progressive disease                18 
Adverse Event                3 
Death                2 
Patient withdrew consent                2 
Eligibility criteria not fulfilled                1 
Lost to Follow-up                1 
Colon metastases                1 
Principal Investigator (PI) decision                1 



  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.
Intent-to-Treat (ITT) population included all enrolled participants.

Reporting Groups
  Description
Rituximab Plus Fludarabine and Cyclophosphamide Elderly participants with chronic lymphocytic leukemia (CLL) received combination treatment with low-dose fludarabine and cyclophosphamide combined with standard-dose of rituximab for 6 months. Treatment was followed by a follow up period of 36 months.

Baseline Measures
   Rituximab Plus Fludarabine and Cyclophosphamide 
Overall Participants Analyzed 
[Units: Participants]
 42 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed   42 
   72.9  (5.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed   42 
Female      13  31.0% 
Male      29  69.0% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.


  Outcome Measures

1.  Primary:   Overall Response Rate   [ Time Frame: Up to 42 months ]

2.  Secondary:   Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Up to 53 months ]

3.  Secondary:   Percentage of Participants With Neutropenic Fever, Infection, >/= Grade 3 Drug-Related Neutropenia, >/= Grade 3 Drug-Related Thrombocytopenia, Hospitalizations   [ Time Frame: Up to 53 months ]

4.  Secondary:   Hospitalization Days   [ Time Frame: Up to 53 months ]

5.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Up to 53 months ]

6.  Secondary:   Quality of Life (QoL): Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Questionnaire   [ Time Frame: [Visit 1 (Screening, Week 0), at Visits 11 (Week 45) and 14 (Week 80) and at the end of the study (Month 42)] ]


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800 821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01263704     History of Changes
Other Study ID Numbers: ML25464
First Submitted: December 17, 2010
First Posted: December 21, 2010
Results First Submitted: March 19, 2018
Results First Posted: April 23, 2018
Last Update Posted: April 23, 2018