Protocol Amendments
Several amendments altered eligibility or therapy during the conduct of AALL02P2. Amendment 1 (March 2007) expanded eligibility to include patients with first isolated CNS or testicular relapse of lymphoblastic lymphoma, changed methotrexate administration from intramuscular to oral during maintenance, and the age for discontinuous dexamethasone (7 days of therapy, 7 days without and 7 days of therapy) administration during Reinduction and the Cranial Irradiation phase was decreased from ≥13 years to ≥10 years. Amendment 2 (August 2008) implemented discontinuous dexamethasone during these phases for all patients based on increased rates of osteonecrosis observed in COG AALL0232.15Amendment 4 (June 2010) removed T-ALL and lymphoblastic lymphoma from the eligibility criteria as only 4 patients had been enrolled among 143. In December 2010 an interim monitoring showed inferior outcomes to POG 9412, resulting in enrollment being suspended and study closure in January 2011 (see below). Amendment 5 (February 2011) was implemented after study closure and recommended that patients who had not yet received cranial irradiation should receive 1800 cGy, and methotrexate administration in maintenance was changed back to intramuscular.