At a glance
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A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy)
In Brief
A Phase 3 clinical trial evaluating Bortezomib, Cyclophosphamide, and 17 other interventions for Adult T Acute Lymphoblastic Leukemia and 7 related conditions. Active but no longer recruiting, targeting 847 participants across 212 sites in 4 countries.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Patients receive combination chemotherapy without bortezomib. See Detailed Description.
Patients receive combination chemotherapy with bortezomib (4 doses at 1.3 mg/m\^2 during Induction and 4 doses at 1.3 mg/m\^2 during Delayed Intensification). See Detailed Description.
Interventions
Given IV
Given IV
Given IT, IV, or SC
Given IV
Given IV
Given PO or IV
Given IV
Given IV
Given IV
Given IT
Given IV
Given PO or IV
Give PO
Given IT, IV, or PO
Given IV
Undergo radiation therapy
Given PO
Given IV
Given IV