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

Phase 3 Active, not recruiting NCT02112916

ConditionAdult 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
PhasePhase 3
SponsorNational Cancer Institute (NCI)
StatusActive, not recruiting
Enrollment847 participants
InterventionsBortezomib, Cyclophosphamide, Cytarabine, Daunorubicin, Daunorubicin Hydrochloride
Start dateOct 4, 2014
Completion dateMar 31, 2020
Results postedFeb 23, 2022

Summary

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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