Phase 2
N=100
A Study in Adults With Untreated Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00136435 ↗Enrolled (actual)
100
Serious AEs
100.0%
Results posted
Oct 2025
Primary outcome: Primary: Asparaginase Completion Rate — 63 Percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- prednisone (Drug); doxorubicin (Drug); vincristine (Drug); methotrexate (Drug); asparaginase (Drug); dexamethasone (Drug); cranial radiation (Radiation); leucovorin (Drug); cytarabine (Drug); hydrocortisone (Drug); 6-mercaptopurine (6-MP) (Drug); e. coli L-asparaginase (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Asparaginase Completion Rate |
63 | — |
| SECONDARY 4-year Disease-Free Survival |
69 | — |
| SECONDARY 4-year Overall Survival |
67 | — |
| SECONDARY 4-year Event-Free Survival |
58 | — |
| SECONDARY Post-Induction Nadir Serum Asparaginase Activity Level |
0; 0.047; 0.0825; 0.088; 0.118; 0.069 | — |
| SECONDARY Number of Participants With Asparaginase-Related Toxicity |
10; 5; 16; 7; 5; 1 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00136435). 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.