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Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00057811
First received: April 7, 2003
Last updated: September 10, 2014
Last verified: September 2014
Results First Received: January 21, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Childhood Burkitt Lymphoma
Childhood Diffuse Large Cell Lymphoma
Childhood Immunoblastic Large Cell Lymphoma
Stage I Childhood Large Cell Lymphoma
Stage I Childhood Small Noncleaved Cell Lymphoma
Stage II Childhood Large Cell Lymphoma
Stage II Childhood Small Noncleaved Cell Lymphoma
Stage III Childhood Large Cell Lymphoma
Stage III Childhood Small Noncleaved Cell Lymphoma
Stage IV Childhood Large Cell Lymphoma
Stage IV Childhood Small Noncleaved Cell Lymphoma
Untreated Childhood Acute Lymphoblastic Leukemia
Interventions: Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Drug: methotrexate
Drug: rasburicase
Drug: leucovorin calcium
Drug: prednisone
Drug: methylprednisolone
Biological: filgrastim
Biological: rituximab
Drug: cytarabine
Drug: etoposide
Drug: vincristine sulfate
Drug: hydrocortisone sodium succinate
Other: laboratory biomarker analysis

  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
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Reporting Groups
  Description
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
Group C (Chemotherapy, Monoclonal Antibody Therapy) Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.

Participant Flow:   Overall Study
    Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)     Group C (Chemotherapy, Monoclonal Antibody Therapy)  
STARTED     51     46  
COMPLETED     41     34  
NOT COMPLETED     10     12  
Lack of Efficacy                 1                 4  
Physician Decision                 1                 0  
Withdrawal by Subject                 3                 4  
Ineligible                 4                 2  
Inevaluable                 1                 2  



  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
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
Group C (Chemotherapy, Monoclonal Antibody Therapy) Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
Total Total of all reporting groups

Baseline Measures
    Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)     Group C (Chemotherapy, Monoclonal Antibody Therapy)     Total  
Number of Participants  
[units: participants]
  51     46     97  
Age  
[units: participants]
     
<=18 years     49     44     93  
Between 18 and 65 years     2     2     4  
>=65 years     0     0     0  
Age  
[units: days]
Median ( Inter-Quartile Range )
  4575  
  ( 2497 to 5638 )  
  3132  
  ( 1940 to 4419 )  
  3853.5  
  ( 2218.5 to 5028.5 )  
Gender  
[units: participants]
     
Female     10     9     19  
Male     41     37     78  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     12     7     19  
Not Hispanic or Latino     39     36     75  
Unknown or Not Reported     0     3     3  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     4     4     8  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     3     5     8  
White     40     34     74  
More than one race     0     0     0  
Unknown or Not Reported     4     3     7  
Region of Enrollment  
[units: participants]
     
United States     47     38     85  
Australia     1     3     4  
Canada     3     5     8  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Grade ≥ 3 Stomatitis   [ Time Frame: Up to 1 year ]

2.  Primary:   Response Rate   [ Time Frame: Up to 5 years ]

3.  Primary:   Minimal Residual Disease   [ Time Frame: Not Provided ]

4.  Primary:   Toxic Death   [ Time Frame: Up to 1 year ]


  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 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: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 626-447-0064
e-mail: resultsreportingcoordinator@childrensoncologygroup.org


Publications:

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00057811     History of Changes
Other Study ID Numbers: ANHL01P1, NCI-2009-00405, COG-ANHL01P1, CDR0000271941, U10CA098543
Study First Received: April 7, 2003
Results First Received: January 21, 2014
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration