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Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00381680
First Posted: September 28, 2006
Last Update Posted: May 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
Results First Submitted: December 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: B-cell Childhood Acute Lymphoblastic Leukemia
L1 Childhood Acute Lymphoblastic Leukemia
L2 Childhood Acute Lymphoblastic Leukemia
Intermediate Risk Recurrent Childhood Acute Lymphoblastic Leukemia
Interventions: Drug: vincristine sulfate
Drug: prednisone
Drug: doxorubicin hydrochloride
Drug: pegaspargase
Drug: cytarabine
Drug: methotrexate
Drug: dexamethasone
Drug: etoposide
Drug: cyclophosphamide
Drug: leucovorin calcium
Biological: filgrastim
Drug: asparaginase
Drug: mercaptopurine

  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
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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
Regimen A: Standard Vincristine Dosing Standard VCR dosing (1.5 mg/m^2, max 2 mg)
Regimen B: Randomized High Dose Vincristine Regimen Intensive VCR dosing (2 mg/m^2, max 2.5 mg)

Participant Flow:   Overall Study
    Regimen A: Standard Vincristine Dosing   Regimen B: Randomized High Dose Vincristine Regimen
STARTED   206   69 
COMPLETED   81   19 
NOT COMPLETED   125   50 
Adverse Event                9                3 
Death                10                7 
Lost to Follow-up                3                2 
Physician Decision                25                6 
Withdrawal by Subject                3                1 
Entry onto another COG Trial                1                2 
Alternative Therapy                11                5 
Secondary Malignancy                3                0 
Delay initiation                1                0 
Stem Cell Transplant                26                10 
Relapse                18                9 
Induction Failure                4                1 
Progression                1                1 
Other not otherwise specified                7                2 
Ineligible                3                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
Regimen A: Standard Vincristine Dosing Standard VCR dosing (1.5 mg/m^2, max 2 mg)
Arm B: Randomized High Dose Vincristine Regimen Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
Total Total of all reporting groups

Baseline Measures
   Regimen A: Standard Vincristine Dosing   Arm B: Randomized High Dose Vincristine Regimen   Total 
Overall Participants Analyzed 
[Units: Participants]
 206   69   275 
Age 
[Units: Years]
Mean (Standard Deviation)
 17.21  (5.20)   19.62  (4.84)   17.82  (5.21) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      96  46.6%      25  36.2%      121  44.0% 
Male      110  53.4%      44  63.8%      154  56.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      55  26.7%      8  11.6%      63  22.9% 
Not Hispanic or Latino      145  70.4%      51  73.9%      196  71.3% 
Unknown or Not Reported      6   2.9%      10  14.5%      16   5.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      3   1.5%      0   0.0%      3   1.1% 
Asian      5   2.4%      2   2.9%      7   2.5% 
Native Hawaiian or Other Pacific Islander      1   0.5%      0   0.0%      1   0.4% 
Black or African American      12   5.8%      3   4.3%      15   5.5% 
White      157  76.2%      55  79.7%      212  77.1% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      28  13.6%      9  13.0%      37  13.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Event Free Survival. EFS   [ Time Frame: 3 years after enrollment ]

2.  Secondary:   Frequency and Severity of Adverse Effects   [ Time Frame: Up to 107 weeks ]

3.  Secondary:   Gene Expression Profile   [ Time Frame: Up to 36 months ]

4.  Secondary:   Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1   [ Time Frame: End of Block 1 (35 days) of Induction therapy ]

5.  Secondary:   Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3   [ Time Frame: End of Block 3 (105 days) of Induction therapy ]

6.  Secondary:   Event Free Survival (EFS)   [ Time Frame: 3 years ]

7.  Secondary:   Adjusted Event Free Survival   [ Time Frame: 3 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
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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: Childrens's Oncology Group
phone: 626-447-0064
e-mail: resultsreportingcoordinator@childrensoncologygroup.org



Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00381680     History of Changes
Other Study ID Numbers: AALL0433
NCI-2009-00306 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-AALL0433 ( Other Identifier: Children's Oncology Group )
CDR0000495359 ( Other Identifier: Clinical Trials.gov )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: September 26, 2006
First Posted: September 28, 2006
Results First Submitted: December 16, 2016
Results First Posted: May 12, 2017
Last Update Posted: May 12, 2017