BENITIONSClinical Trial Intelligence

Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma

3상 진행 중(모집 완료) NCT02112916

대상 질환Adult T Acute Lymphoblastic Leukemia, Ann Arbor Stage II Adult Lymphoblastic Lymphoma, Ann Arbor Stage II Childhood Lymphoblastic Lymphoma, Ann Arbor Stage III Adult Lymphoblastic Lymphoma
임상 단계3상
스폰서National Cancer Institute (NCI)
상태진행 중(모집 완료)
참여자 수847 명
중재(약물)Bortezomib, Cyclophosphamide, Cytarabine, Daunorubicin, Daunorubicin Hydrochloride
시작일2014년 10월 4일
완료일2020년 3월 31일
결과 공개일2022년 2월 23일

요약

This randomized phase III trial compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for cell growth. It may also help chemotherapy work better by making cancer cells more sensitive to the drugs. It is not yet known if giving standard chemotherapy with or without bortezomib is more effective in treating newly diagnosed T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.

Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients

3 years · Percentage of participants

Arm A (Combination Chemotherapy)81.7 Percentage of participants
Arm B (Combination Chemotherapy, Bortezomib)85.1 Percentage of participants
p-value0.074
Hazard Ratio (HR)0.782 (95% CI 0.561–1.091)

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