A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239; IND# 58443) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T- Lymphoblastic Leukemia (T-ALL) and T- Lymphoblastic Lymphoma (T-LLy)

Purpose

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 T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.

Primary Objectives:

I. To compare event-free survival (EFS) in patients with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LLy) who are randomized to a modified augmented Berlin-Frankfurt-Münster (ABFM) backbone versus bortezomib plus the modified ABFM backbone.

Age

18 and under
18 to 65

Gender

N/A

Monetary compensation

No

Can be done from home

No

Keywords

Bortezomib

Principal Investigator

William Slayton, M.D.

Sponsoring Group

Department of Pediatrics

Department

MD-PEDS-HEMATOLOGY

Contact Information

slaytwb@peds.ufl.edu

352.273.9120


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