Trial Outcomes & Findings for Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (NCT NCT00558519)

Last Updated: 2026-04-29

Results Overview

The number of participants who experienced toxicity (defined as at least one grade 3 or higher adverse event at least possibly related to treatment) is reported below.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

318 participants

Primary outcome timeframe

Up to 10 years post-registration

Results posted on

2026-04-29

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Pediatric Regimen) Patients received induction (Course I), consolidation (Course II), interim maintenance (Course III), delayed intensification (Course IV), and long-term maintenance therapy (Course V). Please see the "Detailed Description" section for more information.
Overall Study STARTED	318
Overall Study COMPLETED	295
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Pediatric Regimen) Patients received induction (Course I), consolidation (Course II), interim maintenance (Course III), delayed intensification (Course IV), and long-term maintenance therapy (Course V). Please see the "Detailed Description" section for more information.
Overall Study Ph+	20
Overall Study Ineligible	1
Overall Study Insufficient data	1
Overall Study Never received treatment	1

Baseline Characteristics

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Pediatric Regimen) n=295 Participants Patients received induction (Course I), consolidation (Course II), interim maintenance (Course III), delayed intensification (Course IV), and long-term maintenance therapy (Course V). Please see the "Detailed Description" section for more information.
Age, Continuous	24.0 years n=9 Participants
Sex: Female, Male Female	115 Participants n=9 Participants
Sex: Female, Male Male	180 Participants n=9 Participants

PRIMARY outcome

Timeframe: Up to 8 years post-registration

Complete response rate is defined as the percentage of patients who achieve bone marrow response (defined using the M bone marrow criteria for acute lymphoblastic leukemia (ALL); if M0 to M1 status (blast cells ,5%) was achieved by the end of induction or extended induction, the patient was considered a responder) at the end of induction therapy.

Outcome measures

Outcome measures
Measure	Treatment (Pediatric Regimen) n=295 Participants Patients received induction (Course I), consolidation (Course II), interim maintenance (Course III), delayed intensification (Course IV), and long-term maintenance therapy (Course V). Please see the "Detailed Description" section for more information.
Complete Response Rate	89 percentage of patients Interval 85.0 to 92.0

PRIMARY outcome

Timeframe: Up to 8 years post-registration

EFS was defined as time from registration in this study to the earliest occurrence of any of the following: failure to achieve bone marrow response (defined using the M bone marrow criteria for acute lymphoblastic leukemia (ALL); if M0 to M1 status (blast cells ,5%) was achieved by the end of induction or extended induction, the patient was considered a responder) by day 60, death, relapse at any site, or development of second malignant disease.

Outcome measures

Outcome measures
Measure	Treatment (Pediatric Regimen) n=295 Participants Patients received induction (Course I), consolidation (Course II), interim maintenance (Course III), delayed intensification (Course IV), and long-term maintenance therapy (Course V). Please see the "Detailed Description" section for more information.
Event-free Survival	78.1 months Interval 41.8 to The 95% confidence interval upper limit was not estimable (below the level of detection).

PRIMARY outcome

Timeframe: Up to 8 years post-registration

DFS was defined as time from bone marrow response in this study to the earliest occurrence of any of the following: failure to achieve bone marrow response (defined using the M bone marrow criteria for acute lymphoblastic leukemia (ALL); if M0 to M1 status (blast cells ,5%) was achieved by the end of induction or extended induction, the patient was considered a responder) by day 60, death, relapse at any site, or development of second malignant disease.

Outcome measures

Outcome measures
Measure	Treatment (Pediatric Regimen) n=295 Participants Patients received induction (Course I), consolidation (Course II), interim maintenance (Course III), delayed intensification (Course IV), and long-term maintenance therapy (Course V). Please see the "Detailed Description" section for more information.
Disease-free Survival	81.7 months Interval 58.4 to The 95% confidence interval upper limit was not estimable (below the level of detection).

PRIMARY outcome

Timeframe: Up to 8 years post-registration

OS was defined from registration to death resulting from any cause.