Phase 2
N=60
CINJALL: Treatment for Children With Acute Lymphocytic Leukemia
Acute Lymphocytic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00176462 ↗Enrolled (actual)
60
Serious AEs
93.3%
Results posted
Jun 2014
Primary outcome: Primary: Percentage of Patients With ALL at High Risk of Relapse (Arm 2) Who Were Relapse-free at 5 Years — 64.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 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 (Drug)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With ALL at High Risk of Relapse (Arm 2) Who Were Relapse-free at 5 Years |
64.9 | — |
| SECONDARY To Measure 5-methyltetrahydrofolate, Aminopterin and Methotrexate Uptake in Leukemic Blasts Isolated at Diagnosis |
— | — |
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.
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT00176462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.