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Dasatinib With Fludarabine and Rituximab in Relapsed and Refractory CLL and SLL

This study has been terminated.
(Slow accrual)
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Bristol-Myers Squibb
Information provided by (Responsible Party):
Philip C. Amrein, M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01173679
First received: July 28, 2010
Last updated: March 17, 2017
Last verified: March 2017
Results First Received: January 25, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Interventions: Drug: dasatinib
Drug: Rituximab
Drug: fludarabine

  Participant Flow
  Hide 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
Dasatinib, Rituximab, Fludarabine

Single-arm

dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle

Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).

fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)


Participant Flow:   Overall Study
    Dasatinib, Rituximab, Fludarabine
STARTED   10 
COMPLETED   9 
NOT COMPLETED   1 
Death                1 



  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
Dasatinib, Rituximab, Fludarabine

Single-arm

dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle

Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).

fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)


Baseline Measures
   Dasatinib, Rituximab, Fludarabine 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Years]
Median (Full Range)
 68 
 (60 to 85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      3  30.0% 
Male      7  70.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   10 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Response Rate   [ Time Frame: 2 years ]

2.  Secondary:   Progression-Free and Overall Survival   [ Time Frame: 2 years ]

3.  Secondary:   Toxicities   [ Time Frame: 2 years ]


  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
No text entered.


  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: Philip C. Amrein, M.D.
Organization: Massachusetts General Hospital
phone: 6177243456
e-mail: pamrein@partners.org



Responsible Party: Philip C. Amrein, M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01173679     History of Changes
Other Study ID Numbers: 09-325
Study First Received: July 28, 2010
Results First Received: January 25, 2017
Last Updated: March 17, 2017