CINJALL: Treatment for Children With Acute Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Collaborator: National Cancer Institute (NCI)
• Treatments: 6-Mercaptopurine; Aminopterin; Asparaginase; BB 1101; Cortisol succinate; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Leucovorin; Mercaptopurine; Methotrexate; Thioguanine; Vincristine

Criteria

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.