Clinical trial · Interventional
CINJALL: Treatment for Children With Acute Lymphocytic Leukemia
NCT00176462CI-TRIAL-00014803completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphocytic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 6-mercaptopurine | Drug | Mercaptopurine | ALIAS |
| 6-thioguanine | Drug | Thioguanine | ALIAS |
| aminopterin | Drug | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| daunomycin | Drug | Daunorubicin | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| L-asparaginase | Drug | Asparaginase | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1 Standard Risk
- description
- 6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
- interventionNames
- Drug: L-asparaginase
- Drug: daunomycin
- Drug: dexamethasone
- Drug: 6-mercaptopurine
- Drug: methotrexate
- Drug: vincristine
- Drug: Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone)
- Drug: Leucovorin
- type
- EXPERIMENTAL
- label
- Arm 2 High Risk
- description
- 6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
- interventionNames
- Drug: aminopterin
- Drug: L-asparaginase
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 30 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.