A Study to Evaluate Dexamethasone Compared With Prednisone During Induction Therapy to Treat Patients with Newly-diagnosed, High Risk Acute Lymphoblastic Leukemia

Overview

About this study

AALL0232 is a COG group-wide phase III study designed for NCI high risk patients with acute lymphoblastic leukemia (ALL) from 1-30 years of age. Although event free survival and overall survival continue to increase for children with high risk ALL, CNS disease has become an increasing cause of treatment failure. There is evidence that both dexamethasone and high dose methotrexate prevent CNS relapse. To specifically address the relative increase in CNS events this study will test safety and efficacy of these two therapeutic interventions. The study utilizes a 2 x 2 factorial design with an augmented intensity BFM backbone. Patients will be randomized upfront to receive high dose methotrexate (5 gm/m 2 ) versus Capizzi escalating methotrexate during Interim Maintenance I. A second randomization will compare dexamethasone 10 mg/m2 /day for 14 days versus prednisone 60 mg/m2 /day for 28 days during Induction. Based upon an increased rate of osteonecrosis (ON) observed in patients 10+ years of age randomized to receive dexamethasone during Induction, Amendment #5 restricts the Induction steroid randomization to patients 1-9 years of age, with older patients non-randomly assigned to prednisone during Induction therapy. Patients classified as rapid early responders (RER) will receive one Delayed Intensification course and those classified as slow early responders (SER) will receive two Delayed Intensification courses.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

DISEASE CHARACTERISTICS

  • Newly diagnosed B-precursor acute lymphoblastic leukemia.
  • WBC > 50,000/mm^3 for patients age 1 to 9.
  • Any WBC for patients age 10 to 30 OR patients who have received prior steroid therapy OR patients with testicular disease.
  • Must be eligible for and enrolled on classification study COG-AALL03B1.

PATIENT CHARACTERISTICS

  • Age - 1 to under 31.
  • Performance status - Not specified.
  • Life expectancy - Not specified.
  • Hematopoietic - See Disease Characteristics.
  • Hepatic - Not specified.
  • Renal - Not specified.

PRIOR CONCURRENT THERAPY

  • Biologic therapy - Not specified.
  • Chemotherapy: 
    • No more than 72 hours since prior intrathecal cytarabine;
    • No other prior cytotoxic chemotherapy.
  • Endocrine therapy - Prior steroids allowed.
  • Radiotherapy - Not specified.
  • Surgery - Not specified.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Carola Arndt, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20491273

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