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.
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.