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.