AALL1231 Lymphoblastic Leukemia and Lymphoblastic Lymphoma Study (PRO00002396)

Full Name

COG AALL1231: A Phase III Randomized Trial Investigating Bortezomib on a Modified Augmented BFM Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-LL) and T-Lymphoblastic Lymphoma (T-LLy)


The current standard of treatment for T-lymphoblastic leukemia (T-ALL) and T-lymphoblastic lymphoma (T-LLy) is given in several stages over a few years. Treatment includes chemotherapy, and sometimes high energy x-ray therapy (radiation). The total length of treatment is about 2½ to 3 years. The first stage is called Induction, the goal of which is to remove all visible signs of leukemia. After Induction is a stage called Consolidation. After Consolidation, there are more stages of treatment to make sure the leukemia and lymphoma remains in remission. The treatment the participant receives depends on the T-ALL or T-LLy risk group. Everyone on this study will receive Induction and Consolidation therapy. Participants will receive one of two treatment arms (Arm A or Arm B). Arm A involves the use of a standard approach to treatment for T-ALL in all stages of therapy. Treatment Arm B is the same as Arm A, but with one important difference; the drug bortezomib will also be given during the Induction and Delayed Intensification stages of therapy. Bortezomib is a chemotherapy drug that has been shown to reduce the number of leukemia cells. It may also make other chemotherapy work better. Participants will be randomly assigned to treatment Arm A or Arm B. In addition to the main research study, there are optional research studies (Minimal Residual Disease and specimen banking). Participants can choose to take part in the main research study without participating in the optional research studies.      


Inclusion Criteria

Includes but may not be limited to:

Must be greater than 1 and less than 31 years of age

Must have newly diagnosed T-Lymphoblastic Leukemia or T-Lymphoblastic Lymphoma Stages II-IV

Must not have received any cytotoxic chemotherapy prior to the initiation of protocol therapy (there are exceptions – see protocol)

Must not have uncontrolled seizure disorder

Must not have Down Syndrome

Must not have a hypersensitivity to bortezomib, boron, or mannitol