Intensive Chemotherapy and Rituximab in the Treatment of Burkitt Lymphoma

This study has been terminated.
(closed due to slow accrual)
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by (Responsible Party):
Ann S. LaCasce, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00126191
First received: August 2, 2005
Last updated: April 17, 2013
Last verified: April 2013
Results First Received: November 30, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Burkitt Lymphoma
Non-Hodgkins Lymphoma
Atypical Burkitt Lymphoma
Interventions: Drug: Rituximab
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Methotrexate
Drug: Leucovorin
Drug: Ifosfamide
Drug: Etoposide
Drug: Cytarabine
Drug: Mesna

  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
This BL protocl was IRB approved 01/18/05, activated 7/18/05. Participants were identified either in the outpatient clinic at DFCI or while admitted to our partner inpatient hospital, Brigham & Women's Hospital. The study was closed to accrual 6/2/08 due to slow accrual.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with previous chemotherapy or radiation, uncontrolled infection, concomitant malignancy (some exclusions), serious comorbid disease, pregnancy, and HIV+ were excluded. Subjects stratified according to risk: Single focus disease <10cm and normal LGH=low risk, all others high risk.

Reporting Groups
  Description
Low Risk Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
High Risk Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).

Participant Flow:   Overall Study
    Low Risk     High Risk  
STARTED     2     8  
COMPLETED     2     6 [1]
NOT COMPLETED     0     2  
Physician Decision                 0                 1  
Death                 0                 1  
[1] 1 pt off study during cycle 1 due to toxicity



  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
Low Risk Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
High Risk Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
Total Total of all reporting groups

Baseline Measures
    Low Risk     High Risk     Total  
Number of Participants  
[units: participants]
  2     8     10  
Age [1]
[units: participants]
     
<=18 years     1     0     1  
Between 18 and 65 years     1     8     9  
>=65 years     0     0     0  
Age  
[units: participants]
     
<=18 years     1     0     1  
Between 18 and 65 years     1     8     9  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     0     1     1  
Male     2     7     9  
Region of Enrollment  
[units: participants]
     
United States     2     8     10  
[1] IRB approved deviation to register 1 patient at age 17.



  Outcome Measures
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1.  Primary:   Response Rates (CR and PR) in Adults With Burkitt/Atypical Burkitt   [ Time Frame: 3 years ]

2.  Secondary:   Disease Free Survival   [ Time Frame: Until disease progression up to 120 months ]


  Serious Adverse Events


  Other Adverse Events


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


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
Early termination leading to small numbers of subjects analyzed.  


Results Point of Contact:  
Name/Title: Ann LaCasce, MD
Organization: DFCI
phone: 617-632-5959
e-mail: ALACASCE@PARTNERS.ORG


No publications provided


Responsible Party: Ann S. LaCasce, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00126191     History of Changes
Other Study ID Numbers: 04-336
Study First Received: August 2, 2005
Results First Received: November 30, 2012
Last Updated: April 17, 2013
Health Authority: United States: Institutional Review Board