CINJALL: Treatment for Children With Acute Lymphocytic Leukemia

This study has been terminated.
(accrual goal met)
Sponsor:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00176462
First received: September 12, 2005
Last updated: December 10, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Acute Lymphocytic Leukemia
Drug: aminopterin
Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunomycin
Drug: dexamethasone
Drug: hydrocortisone
Drug: 6-mercaptopurine
Drug: methotrexate
Drug: 6-thioguanine
Drug: vincristine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CINJALL: Treatment for Children With Acute Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • The purpose of this research study is to identify better ways to treat children and young adults with acute lymphocytic leukemia (ALL). [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To measure 5-methytltetrahydrofolate, aminopterin and methotrexate uptake in leukemic blasts isolated at diagnosis [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 64
Study Start Date: February 2001
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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: 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: hydrocortisone
    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
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Year to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion/Exclusion Criteria:

Newly Diagnosed ALL, excluding mature B-cell ALL (surface Ig positive) Patients with overt CNS or testicular disease are eligible Informed consent according to institutional and FDA guidelines. Adequate organ function is required. 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.

HIV seropositive patients will not be excluded from this study. Patients with medical, psychological, or psychiatric problems that are likely to compromise their ability to tolerate intensive therapy will be ineligible. Any questions about the appropriateness of patient for this study should be directed to the Principal Investigator.

Patients greater than 1 year of age and less than 29.99 years of age are eligible.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00176462

Locations
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
Principal Investigator: Peter Cole, MD Rutgers, The State University of New Jersey
  More Information

No publications provided

Responsible Party: Barton Kamen, UMDNJ
ClinicalTrials.gov Identifier: NCT00176462     History of Changes
Other Study ID Numbers: 020101-0220003389, CINJ#020101
Study First Received: September 12, 2005
Last Updated: December 10, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of New Jersey:
Acute Lymphocytic Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
6-Mercaptopurine
Cytarabine
Methotrexate
Thioguanine
Cyclophosphamide
Asparaginase
Daunorubicin
Dexamethasone
Vincristine
Aminopterin
BB 1101
Dexamethasone acetate
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Dexamethasone 21-phosphate
Hydrocortisone-17-butyrate
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014