Clinical Trial: Cancer, Leukemia and Lymphoma

AALL1331 B-Lymphoblastic Leukemia study (PRO00003569)

Full Name

AALL1331: Risk-Stratified Randomized Phase III Testing of Blinatumomab (IND#117467, NSC#765986) in First Relapse in Childhood B-Lymphoblastic Leukemia (B-ALL)


If you choose to participate, you will be assigned to one of four groups.  All patients on this study will receive Block 1 therapy. The goal of Block 1 of this study is to use combination chemotherapy drugs on relapse leukemia subjects.   The treatment in Block 1 is not new and is based on treatment given for many years in the United Kingdom and Europe.  Block 1 treatment lasts for 4 weeks, and may include the following drugs:  Mitoxantrone, dexamethasone, vincristine, pegaspargase, methotrexate, and triple intrathecal therapy (also known as "Triple IT," and is made up of methotrexate, hydrocortisone and cytarabine). At the end of Block 1, your bone marrow will be tested for minimal residual disease (MRD).  The MRD result will be used to help determine if you are "intermediate risk" or "low risk" after Block 1 therapy.  After Block 1 therapy, if your B-ALL has been classified as high risk (HR) or intermediate risk (IR), you will be randomly assigned to one of two arms.  One arm uses chemotherapy drugs (this arm is also called the "control" arm) that are FDA approved.  The other arm uses chemothearpy plus an investigational medicine called Blinatumomab (this arm is also called the "experimental" arm).  If you are assigned to the control arm, you will receive Block 2 and Block 3 of combination chemotherapy, followed by a stem cell transplant.  If you are assigned to the experimental arm, you will receive 2 blocks of chemotherapy plus blinatumomab followed by a stem cell transplant.  If your disease is considered "low risk," you will be randomly assigned to 1 of 2 arms.  One arm will receive chemotherapy (this arm is also called a "control" arm) that are FDA approved. The other arm uses chemotherapy plus an investigational medicine called Blinatumomab (also called an "experimental" arm).   If you are assigned to the control arm, you will receive a second and third block of combination chemotherapy, followed by 2 blocks of continuation and 1 block of maintenance.  If you are assigned to the experimental arm, you will receive a second block of chemotherapy followed by 3 4-week blocks of blinatumomab (followed by 1 week off), with 2 blocks of Continuation given in between.  If your disease did not respond to therapy after Block 1 (all patients) or Block 2 (High Risk/Intermediate Risk Patients on Arm A), you will be given 2 cycles of blinatumomab and then your bone marrow will be tested for minimal residual disease (MRD). If you are in remission after completion of blinatumomab therapy, you will then be able to undergo stem cell transplant.  Some participants will receive standard stem cell transplant, while others will receive experimental stem cell transplant.  The experimental stem cell transplant is the same as standard stem cell transplant except that the experimental stem cell transplant includes taking drugs called immunosuppressive therapy for a shorter time than what is standard after stem cell transplant.   


Inclusion Criteria

Must not have had a prior stem cell transplant or rescue

Must not have had prior treatment with blinatumomab

First relapse of B-ALL with or without extamedullary disease; extramedullary sites are limited to the Central Nervous System (CNS) and testicles

Must not have received prior relapse-directed therapy

Must not have T-lymphoblastic Leukemia (T-ALL) or T-lymphoblastic Lymphoma (T-LL)

Must not have known optic nerve and/or retinal involvement are not eligible