CINJALL: Treatment for Children With Acute Lymphocytic Leukemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00176462
First received: September 12, 2005
Last updated: May 12, 2014
Last verified: May 2014
Results First Received: November 15, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Lymphocytic Leukemia
Interventions: Drug: aminopterin
Drug: L-asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunomycin
Drug: dexamethasone
Drug: 6-mercaptopurine
Drug: methotrexate
Drug: 6-thioguanine
Drug: vincristine
Drug: Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone)
Drug: Leucovorin

  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
59 patients with ALL were enrolled between March, 2001 and September, 2005 at the Cancer Institute of New Jersey (outpatient clinical research facility) and 1 patient was enrolled at Jersey Shore University Medical Center (a community hospital).

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
Arm 1 Standard Risk 6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
Arm 2 High Risk 6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C

Participant Flow for 5 periods

Period 1:   Induction (4 Weeks)
    Arm 1 Standard Risk     Arm 2 High Risk  
STARTED     21     39  
COMPLETED     20     34  
NOT COMPLETED     1     5  
Withdrawal by Subject                 0                 2  
Death                 1                 2  
Lack of Efficacy                 0                 1  

Period 2:   Consolidation (12 Weeks)
    Arm 1 Standard Risk     Arm 2 High Risk  
STARTED     20     34  
COMPLETED     20     29  
NOT COMPLETED     0     5  
Patient moved to another state                 0                 1  
Adverse Event                 0                 1  
Lack of Efficacy                 0                 2  
Not documented                 0                 1  

Period 3:   Delayed Intensification (8 Weeks)
    Arm 1 Standard Risk     Arm 2 High Risk  
STARTED     20     29  
COMPLETED     20     29  
NOT COMPLETED     0     0  

Period 4:   Intensive Continuation (8X8-week Cycles)
    Arm 1 Standard Risk     Arm 2 High Risk  
STARTED     20     29  
COMPLETED     19     26  
NOT COMPLETED     1     3  
Death                 1                 0  
Lack of Efficacy                 0                 3  

Period 5:   Continuation -up to 30mos Post Remission
    Arm 1 Standard Risk     Arm 2 High Risk  
STARTED     19     26  
COMPLETED     19     26  
NOT COMPLETED     0     0  



  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
Arm 1 Standard Risk 6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
Arm 2 High Risk 6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
Total Total of all reporting groups

Baseline Measures
    Arm 1 Standard Risk     Arm 2 High Risk     Total  
Number of Participants  
[units: participants]
  21     39     60  
Age  
[units: participants]
     
<=18 years     21     30     51  
Between 18 and 65 years     0     9     9  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  3.71  ± 1.77     16  ± 9.8     11.7  ± 9.89  
Gender  
[units: participants]
     
Female     11     18     29  
Male     10     21     31  
Region of Enrollment  
[units: participants]
     
United States     21     39     60  



  Outcome Measures
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1.  Primary:   Percentage of Patients With ALL at High Risk of Relapse (Arm 2) Who Were Relapse-free at 5 Years   [ Time Frame: 5 years ]

2.  Secondary:   To Measure 5-methyltetrahydrofolate, Aminopterin and Methotrexate Uptake in Leukemic Blasts Isolated at Diagnosis   [ Time Frame: 5 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
Antifolate therapy was non-randomly assigned, therefore, we do not have a statistical basis to compare the toxicity observed among patients on the standard risk and high risk treatment arms.


  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: Richard Drachtman, MD
Organization: Rutgers Cancer Institute of New Jersey
phone: 732-235-8675
e-mail: drachtri@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu


No publications provided


Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00176462     History of Changes
Other Study ID Numbers: 020101, 0220003389, P30CA072720
Study First Received: September 12, 2005
Results First Received: November 15, 2013
Last Updated: May 12, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board