Brief 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\>

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

112

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Apr 2007

Longer than P75 for phase_2

Geographic Reach

2 countries

15 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

12.9 years study duration

Study Start

First participant enrolled

April 1, 2007

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2007

Completed

3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2007

Completed

6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed

6.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed

5.3 years until next milestone

Results Posted

Study results publicly available

June 12, 2025

Completed

Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

6.4 years

First QC Date

May 18, 2007

Results QC Date

May 8, 2025

Last Update Submit

June 10, 2025

Conditions

Acute Lymphoblastic Leukemia

Keywords

ALL

Outcome Measures

Primary Outcomes (2)

Asparaginase Completion Rate
Feasibility based on the rate of asparaginase completed defined as the percentage of patients who, after having achieved a complete remission after induction therapy, complete \>25 weeks of IV PEG asparaginase as part of intensification therapy. Complete remission is defined as an interpretable bone marrow (a specimen with normal marrow elements present) with fewer than 5% lymphoblasts and peripheral blood without lymphoblasts, and an antigen presenting cell (APC) \> 1000/mm3 and platelets \> 100,000/mm3, and no evidence of extramedullary leukemia.
Assessed at the end of the 30-week post-induction treatment period or when the participant comes off treatment, whichever occurs first.
Number of Participants With Grade 3 or Worse Toxicity.
Defined as the number of participants who experience the following grade 3 or worse adverse events based on Common Terminology Criteria for Adverse Events (CTCAE) v3: Neutrophils, Platelets, Febrile neutropenia, Infection, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Bilirubin, Liver dysfunction/failure, Hyperglycemia, Stomatitis, CNS hemorrhage, Thrombosis, Seizure, Osteonecrosis, Hypersensitivity, Pancreatitis, Neuropathy.
Assessed on an ongoing basis (at least once every 3 months) while on study, including the treatment phases of Induction, Consolidation I & II, CNS, and Continuation. Treatment duration for this study was a median (range) of 287 days (2-974).

Secondary Outcomes (3)

Complete Remission Rate
3-day Steroid prophase and 4-week induction treatment period. Participants are assessed on Day 32 of induction.
3-year Disease Free Survival
Assessed continuously throughout the treatment period, and annually for 5 years following the completion of protocol treatment (up to 5 years). Relevant for this measure is 3 years from the date of complete remission.
3-year Overall Survival
Assessed continuously throughout the treatment period, and annually for 5 years following the completion of protocol treatment (up to 5 years). Relevant for this measure is 3 years from the date of study entry.

Study Arms (2)

Pre-amendment cohort, 2500 IU/m2 q2 weeks

EXPERIMENTAL

The first 66 patients enrolled under the initial design. In the post-induction phases, IV asparaginase was administered every two weeks at the higher dose of 2500 IU/m2, for a total of 30 post-induction weeks. IV asparaginase was administered as a single dose during induction. Protocol therapy was comprised of 6 phases: Prophase, Induction, Consolidation I, CNS, Consolidation II, and Continuation, and varied based off risk classification.

Drug: DoxorubicinDrug: CytarabineDrug: MethotrexateDrug: VincristineDrug: CyclophosphamideDrug: MethylprednisoneDrug: Hydrocortisone Sodium SuccinateDrug: DexamethasoneDrug: 6-MPDrug: PEG-AsparaginaseDrug: ImatinibDrug: EtoposideProcedure: Radiation TherapyDrug: E. coli Asparaginase

Post-amendment cohort, 2000 IU/m2 q3 weeks

EXPERIMENTAL

The 46 patients enrolled under amended design, after August 1, 2011. In the post-induction phases, IV asparaginase was administered every 3 weeks at the dose of 2000 IU/m2, for a total of 30 post-induction weeks. E. coli asparaginase was administered as a single dose during induction. Protocol therapy was comprised of 6 phases: Prophase, Induction, Consolidation I, CNS, Consolidation II, and Continuation, and varied based off risk classification.

Interventions

DoxorubicinDRUG

Induction: Intravenously on days 4 and 5. Consolidation 1A: Intravenously on day 1. CNS Therapy: Intravenously on day 1. Consolidation II: Intravenously day 1 of each cycle.