Phase 2
N=112
ALL Adult Consortium Trial: Adult ALL Trial
Acute Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00476190 ↗Enrolled (actual)
112
Serious AEs
100.0%
Results posted
Jun 2025
Primary outcome: Primary: Asparaginase Completion Rate — 43; 79 Percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Doxorubicin (Drug); Cytarabine (Drug); Methotrexate (Drug); Vincristine (Drug); Cyclophosphamide (Drug); Methylprednisone (Drug); Hydrocortisone Sodium Succinate (Drug); Dexamethasone (Drug); 6-MP (Drug); PEG-Asparaginase (Drug); Imatinib (Drug); Etoposide (Drug); Radiation Therapy (Procedure); E. coli Asparaginase (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Asparaginase Completion Rate |
43; 79 | — |
| PRIMARY Number of Participants With Grade 3 or Worse Toxicity. |
49; 31; 44; 30; 30; 23 | — |
| SECONDARY Complete Remission Rate |
57; 34 | — |
| SECONDARY 3-year Disease Free Survival |
70; 75 | — |
| SECONDARY 3-year Overall Survival |
70; 83 | — |
Summary
The purpose of this study is to determine the safety and effectiveness of a multi-drug chemotherapy regimen in adult patients with Acute Lymphoblastic Leukemia (ALL). We will use a regimen that is often used in pediatric patients and we will add drugs called PEG-asparaginase and E. coli asparaginase. PEG-asparaginase has been given as an injection in the past and has been used in treatment with both children and adults with ALL. Information from those other research studies suggests that intravenous PEG-asparaginase has been administered safely in both children and adults. We hope to gain more information about the participants disease and how it responds to standard chemotherapy drugs used to treat ALL>
Eligibility Criteria
Inclusion Criteria
- Acute lymphoblastic leukemia, excluding known mature B-cell ALL by the presence of any of the following: surface immunoglobulin, L3 morphology, t(8;14)(q24;q32), t(8;22), or t(2;8)
- Age 18.00-50.99 years
Exclusion Criteria
- Prior anti-leukemic therapy except 1 week or less of steroids, and/or emergent radiation therapy to the mediastinum, or hydroxyurea or emergent leukopheresis
- Known HIV positive
- Secondary ALL
- Pregnant or breast feeding women
- Patients with an active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely
Data sourced from ClinicalTrials.gov (NCT00476190). 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.