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

This randomized phase III trial is studying different combination chemotherapy regimens and comparing how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia. RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

Official Title

Standard Risk B-Precursor Acute Lymphoblastic Leukemia

Conditions

Acute Lymphoblastic Leukemia

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label

Further Details

Primary Objectives:

• Compare event-free survival of pediatric patients with newly diagnosed, standard-risk (SR)-average, B-precursor acute lymphoblastic leukemia (ALL) treated with induction therapy followed by 1 of 4 intensified phases of post-induction therapy.
• Compare event-free survival of pediatric patients with SR-low ALL treated with consolidation and interim maintenance therapy with or without additional pegaspargase.

Secondary Objectives:

• Correlate day 29 minimal residual disease (MRD) status with event-free survival and overall survival of patients treated with these regimens.
• Correlate early marrow response with day 29 MRD status in patients treated with these regimens.
• Determine whether outcome is improved for SR-high patients by identifying these patients by day 29 MRD status and subsequently treating these patients with a fully augmented Berlin Frankfurt Munster regimen.
• Correlate relative contributions of genetic factors and early treatment response with outcome in patients treated with these regimens

Study Start

January 2005

Eligibility & Criteria

• Ages Eligible for Study: 1 Year – 9 Years
• Genders Eligible for Study: Both

Inclusion Criteria: DISEASE CHARACTERISTICS:

• Newly diagnosed B-precursor acute lymphoblastic leukemia (Standard-risk (SR) disease – see link below for details)
• Patients with Down syndrome are allowed
• Concurrently enrolled on COG-AALL03B1

PATIENT CHARACTERISTICS:

• Age: 1 to 9 years
• Hematopoietic: Initial WBC < 50,000/mm³

PRIOR CONCURRENT THERAPY:

• Chemotherapy: No prior cytotoxic chemotherapy except intrathecal cytarabine
• Endocrine therapy: Prior steroid therapy allowed at the discretion of the investigator; No contraindication to additional asparaginase therapy after induction for the standard risk-low study
• Radiotherapy: No concurrent intensity-modulated radiotherapy

Total Enrolment

3381

Contact Details

John Hunter Hospital, Newcastle, New South Wales, 2310, Australia; Recruiting

• Frank Alvaro: 612 4921 3080

Royal Children’s Hospital, Herston, Brisbane, Queensland, 4029, Australia; Recruiting

• Helen Irving: 617 3636 8671

Royal Children’s Hospital, Parkville, Victoria, 3052, Australia; Recruiting

• John A. Heath: 613 9345 4864

Princess Margaret Hospital for Children, Perth, Western Australia, 6001, Australia; Recruiting

• David Baker: 618 9340 8234

For more information, click here