Clinical trial · Interventional
A Study in Adults With Untreated Acute Lymphoblastic Leukemia
A Multicenter Phase II Study in Adults With Untreated Acute Lymphoblastic Leukemia: Testing Pharmacokinetically Individualized Doses of L-Asparaginase Following the Dana Farber Cancer Institute (DFCI) Pediatric Consortium Protocol
NCT00136435CI-TRIAL-00096653completedPhase 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 study is to determine the safety and optimal dosing of L-asparaginase in adult patients with acute lymphoblastic leukemia (ALL) between the ages of 18 and 50 years.
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 Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 6-mercaptopurine (6-MP) | Drug | Mercaptopurine | ALIAS |
| asparaginase | Drug | Asparaginase | ALIAS |
| cranial radiation | Radiation | — | UNRESOLVED |
| cytarabine | Drug | Cytarabine | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| doxorubicin | Drug | Doxorubicin | ALIAS |
| e. coli L-asparaginase | Drug | Asparaginase | ALIAS |
| hydrocortisone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Only Arm for this study
- description
- Only Arm for this study
- interventionNames
- Drug: prednisone
- Drug: doxorubicin
- Drug: vincristine
- Drug: methotrexate
- Drug: asparaginase
- Drug: dexamethasone
- Radiation: cranial radiation
- Drug: leucovorin
- Drug: cytarabine
- Drug: hydrocortisone
- Drug: 6-mercaptopurine (6-MP)
- Drug: e. coli L-asparaginase
Primary outcomes (1)
- measure
- Asparaginase Completion Rate
- timeFrame
- Assessed at the end of the 30-week post-induction treatment period or when the participant comes off treatment, whichever occurs first.
- description
- Feasibility based on the rate of asparaginase completion defined as the percentage of patients who, after having achieved a complete remission after induction therapy, complete all 30 doses of asparaginase as part of intensification therapy. Complete remission is defined as peripheral blood without lymphoblasts, a bone marrow with \<5% lymphoblasts, an antigen-presenting cell (APC) \> 1000/mm3, platelets \> 100,000/mm3, and no evidence of extramedullary leukemia.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have pathologically documented acute lymphoblastic leukemia, excluding mature B-cell ALL. * No prior therapy for leukemia with the following exceptions: * up to one week of steroids; * emergent leukapheresis; * emergency treatment for hyperleukocytosis with hydroxyurea; * cranial RT for CNS leukostasis (one dose only); * emergent radiation therapy to the mediastinum. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. * Between the ages of 18 to 50 years. Exclusion Criteria: * Uncontrolled active infection. * Pregnancy or nursing mothers. * Prior history of pancreatitis. * Prior history of a cerebrovascular accident or hemorrhage. * Evidence of infection with the human immunodeficiency virus. * Active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely. * The treating physician should consider all relevant medical and other considerations when deciding whether this protocol is appropriate for a particular patient.
References
Publications (0)
Data not yet available
No reference posted for this study.