Cleveland Clinic researchers are investigating a new approach for treating acute lymphoblastic leukemia (ALL) in older adolescents and young adults. Preliminary trial results show significant improvement in this patient subset when treated with pediatric regimens.
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“Multiple retrospective clinical trials demonstrated a superior outcome for young adult patients treated with pediatric regimen as compared to conventional adult regimens, and multiple groups have replicated these results,” says Anjali Advani, MD, Director of the Inpatient Leukemia Program at Cleveland Clinic’s Taussig Cancer Institute.
Intergroup trial C10403 evaluated the feasibility and effectiveness of treating older adolescent and young adult (AYA) patients using the successful Children’s Oncology Group regimen with two-year, event-free survival as a primary endpoint.
Newly diagnosed AYA patients, ages 16 to 39, with B-precursor (B-ALL) or T-precursor (T-ALL) ALL were eligible to enroll. Study criteria excluded those with Burkitt’s-type and Ph+ ALL. Investigators used the PC arm (prednisone, capizzi methotrexate) of the Children’s Oncology Group regimen (COG AALL0232) in the trial.
Of the 318 patients enrolled, 22 withdrew prior to beginning therapy. The 296 remaining patients had a median age at diagnosis of 24 and ranged from 17 to 39 years of age:
The majority (76 percent) had B-ALL and were male (61 percent). During protocol therapy, there were five treatment-related deaths, but overall treatment toxicities were similar to those reported in the standard arm of COG AALL0232.
“We saw a significant improvement in patients using this pediatric regimen. This study, along with the retrospective clinical trials, lays the foundation for future trials incorporating novel agents to further improve survival of young adults with acute lymphoblastic leukemia,” says Dr. Advani. Investigators presented the study abstract and further details at the 56th American Society of Hematology Annual Meeting.
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