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

September 12, 2005
May 12, 2014
February 2001
September 2008   (final data collection date for primary outcome measure)
Percentage of Patients With ALL at High Risk of Relapse (Arm 2) Who Were Relapse-free at 5 Years [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
This measure looks at the percentage of patients on Arm 2 who did not experience a relapse at 5 years, where relapse is defined as the presence of progressive disease after the achievement of a complete remission.
To pilot the substitution of oral divided-dose aminopterin for oral divided-dose methotrexate in the setting of combination chemotherapy for newly diagnosed patients.
Complete list of historical versions of study NCT00176462 on ClinicalTrials.gov Archive Site
To Measure 5-methyltetrahydrofolate, Aminopterin and Methotrexate Uptake in Leukemic Blasts Isolated at Diagnosis [ Time Frame: 5 years ] [ Designated as safety issue: No ]
To measure 5-methytltetrahydrofolate, aminopterin and methotrexate uptake in leukemic blasts isolated at diagnosis
Not Provided
Not Provided
 
CINJALL: Treatment for Children With Acute Lymphocytic Leukemia
CINJALL: Treatment for Children With Acute Lymphocytic Leukemia

The purpose of this research study is to identify better ways to treat children and young adults with acute lymphocytic leukemia (ALL). At the same time, doctors hope to define methods to identify those patients at higher risk for certain side effects, as well as those who are at higher risk for relapse of their leukemia.

Outline of Therapy:

Combinations of chemotherapy drugs will be given orally, intravenously and intrathecally (directly into the cerebrospinal fluid by spinal tap) over a period of roughly two and a half years.

Therapy will be divided into five phases:

Induction (4 weeks): chemotherapy given to produce a clinical remission (defined by normal blood counts, with the absence of leukemia cells in the blood and fewer than 5% leukemia cells in the bone marrow).

Consolidation (11 weeks): chemotherapy given to consolidate the remission. Delayed Intensification (7 weeks) Intensive chemotherapy aimed at killing any resistant leukemia cells will be given only for patients at high risk of relapse.

Intensive Continuation (approximately 1 year): Eight week cycles of chemotherapy, given eight times.

Continuation (final year of therapy): Eight week cycles of largely oral chemotherapy, with one clinic visit for a lumbar puncture every eight weeks.

Irradiation: radiation will be given in the middle of intensive continuation to the head and spine of those patients who have leukemia cells found in the cerebrospinal fluid at the time of diagnosis.

Follow-up: After the conclusion of therapy, there will be periodic office visits, initially monthly, then gradually spaced out to annual visits. The purpose of these visits is to evaluate for late side-effects of therapy.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Lymphocytic Leukemia
  • Drug: aminopterin
    Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
  • Drug: L-asparaginase
    Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
  • Drug: cyclophosphamide
    Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
  • Drug: cytarabine
    Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
  • Drug: daunomycin
    Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
  • Drug: dexamethasone
    Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
  • Drug: 6-mercaptopurine
    Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
  • Drug: methotrexate
    Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
  • Drug: 6-thioguanine
    Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
  • Drug: vincristine
    Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation
  • Drug: Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone)
  • Drug: Leucovorin
  • Experimental: Arm 1 Standard Risk
    6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
    Interventions:
    • Drug: L-asparaginase
    • Drug: daunomycin
    • Drug: dexamethasone
    • Drug: 6-mercaptopurine
    • Drug: methotrexate
    • Drug: vincristine
    • Drug: Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone)
    • Drug: Leucovorin
  • Experimental: Arm 2 High Risk
    6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
    Interventions:
    • Drug: aminopterin
    • Drug: L-asparaginase
    • Drug: cyclophosphamide
    • Drug: cytarabine
    • Drug: daunomycin
    • Drug: dexamethasone
    • Drug: 6-mercaptopurine
    • Drug: 6-thioguanine
    • Drug: vincristine
    • Drug: Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone)
    • Drug: Leucovorin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion:

  • Newly Diagnosed ALL, excluding mature B-cell ALL (surface Ig positive)
  • Patients with overt CNS (central nervous system) or testicular disease are eligible
  • Informed consent according to institutional and FDA guidelines.
  • Adequate organ function is required.
  • HIV seropositive patients will not be excluded from this study.
  • Patients greater than 1 year of age and less than 29.99 years of age are eligible.

Exclusion Criteria

  • Patients with medical, psychological, or psychiatric problems that are likely to compromise their ability to tolerate intensive therapy will be ineligible.
  • All patients with evidence of significant organ dysfunction not thought to be attributable to ALL (patients with clinically significant congestive heart failure, cardiac ejection fraction <40%, total bilirubin >2, serum creatinine >2) will be ineligible. Note: echocardiogram or MUGA are required prior to therapy ONLY for those patients with history or physical findings suggestive of cardiac dysfunction not directly attributable to anemia or ALL. Note: Patients with total bilirubin >2 but direct (conjugated) bilirubin less than the upper limit of normal will still be eligible. These patients should be evaluated for deficiency of the enzyme glucuronyl transferase.
Both
1 Year to 30 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00176462
020101, 0220003389, P30CA072720
No
Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Principal Investigator: Barton Kamen, MD Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP