Last updated on June 2017

Hyper-CVAD Regimen in Sequential Combination With Blinatumomab as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia


Brief description of study

The goal of this clinical research study is to learn if Blinacyto (blinatumomab), when given after Hyper-CVAD, can help to control newly diagnosed B-Cell Lineage ALL. The safety of this drug will also be studied.

Detailed Study Description

Study Drug Administration: Study Cycles 1-4 are about 3 weeks each. Study Cycles 5-8 are 6 weeks each. If you are found to be eligible to take part in this study, you will receive a CVC if you do not already have one. A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure. Hyper-CVAD (Cycles 1 and 3): During Cycles 1 and 3 you will also receive the following drugs: - On Days 1-3, you will receive cyclophosphamide 2 times each day by vein over 3 hours. - On Days 1-3, you will receive mesna by vein non-stop to help prevent side effects. The mesna infusion will start about one hour prior and end about 12 hours after the last dose of cyclophosphamide. - On Days 1-4 and 11-14, you will receive dexamethasone 1 time a day by mouth or by vein over 30 minutes. - On Days 1 and 11, if your doctor thinks it is in your best interest, you may receive ofatumumab or rituximab by vein over about 4 to 6 hours. The study doctor will decide how long the infusion will last. If you receive ofatumumab, you will also receive a dose on Day 2 of Cycle 1. - On Day 2, you will receive methotrexate by lumbar puncture. - On Day 4, you will receive doxorubicin by vein non-stop for 1 day through the CVC. - On Days 4 and 11, you will receive vincristine by vein over 15 minutes. - On Day 7, you will receive cytarabine by lumbar puncture. During Cycles 2 and 4, you will also receive the following drugs: - On Day 1, you will receive methotrexate by vein over 24 hours. - On Days 1 and 8, if your doctor thinks it is in your best interest, you may receive ofatumumab or rituximab by vein over about 4 to 6 hours. The study doctor will decide how long the infusion will last. - On Days 2 and 3, you will receive cytarabine by vein 2 times each day over 2 hours. - On Day 5, you will receive cytarabine by lumbar puncture. - On Day 8, you will receive methotrexate by lumbar puncture. You may receive filgrastim or pegfilgrastim as an injection under the skin at the end of every cycle to help raise your blood cell counts. If your doctor thinks it is needed to help reduce the risk of side effects, you may receive leucovorin by vein 4 times a day for 8 doses, beginning 12 hours after the methotrexate dose ends. You may be given other drugs to help prevent side effects. The study staff will tell you about these drugs, how they will be given, and the possible risks. After you have finished receiving Hyper-CVAD, you will receive blinatumomab nonstop for Weeks 1-4 every 6 weeks of Cycles 5-8. If your doctor thinks it is in your best interest, he may choose to begin blinatumomab earlier than Cycle 5. You will receive blinatumomab through a peripherally inserted central catheter. This allows you to receive the drug constantly over a long period of time. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure. During the first cycle of blinatumomab, the infusion will be started in the hospital. You will be in the hospital for up to 9 nights so that you can be monitored for side effects. Your doctor will decide when you can leave the hospital. Blinatumomab will be delivered by a small pump, which you will carry with you for the whole time you receive the drug. You will be given a shoulder or belt bag to hold the pump and infusion bag. You will be able to wear regular clothes, walk around, and perform daily living activities. You will be given instructions for taking a shower and other activities. However, because the line must be kept free of infection and connected to the pump, there will be some things that you should not do, such as go swimming. The study staff will give you more information on activities you should not do while receiving the drug. You will need to come to MD Anderson to have the infusion bags changed every 48 hours. The study staff will let you know if you need to return to the clinic. Maintenance Therapy: After you have received 4 cycles of blinatumomab, you may be able to receive maintenance therapy for about 12 months. During Maintenance Therapy, you will receive the following drugs: - Every day, you will take 6-mercaptopurine by mouth 3 times. - Every week, you will take pills of methotrexate. - Every month, you will receive vincristine by vein 1 time over about 15 minutes. - On Days 1-5 of every month, you will take prednisone by mouth. Study Visits: At the beginning of every cycle, and monthly during the Maintenance Phase, you will have a physical exam. One (1) time each week during Cycles 1-8, then every month during the Maintenance Phase, blood (about 2-3 teaspoons) will be drawn for routine tests. On Day 14 (+/- 3 days) of Cycle 1, you will have a bone marrow biopsy/aspiration to check the status of the disease This will then be done every week until the disease appears to go away. If the disease appears to completely go away, you may not need to have another bone marrow biopsy/aspiration until after you finish receiving Hyper CVAD and/or before you begin receiving blinatumomab. Within 14 days before you receive blinatumomab, you will have a neurological exam. If the disease does not appear to have completely gone away, on Days 28 and 42 (+/- 7 days) of Cycle 5, you will have a bone marrow biopsy/aspiration to check the status of the disease. This will then be done after every cycle while you receive blinatumomab, and then every 4 months after that. If the disease does appear to have completely gone away, you will have a bone marrow biopsy/aspiration every 4 months after you begin receiving blinatumomab. At any point that the doctor thinks it is needed, you will have a PET-CT scan or x-ray to check the status of the disease. Length of Study: You will receive up to 4 cycles of intensive chemotherapy and up to 4 cycles of blinatumomab, followed by about 1 year of maintenance therapy. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Follow-Up: You will be called by the study staff and asked about your health 1 time each month for up to 24 months after all participants have been enrolled in the study. These calls should last about 5-10 minutes each. This is an investigational study. Blinatumomab is FDA approved and commercially available for the treatment of ALL that has been treated before or has come back. It is investigational to use the drug as a first option for the treatment of the disease. Hyper-CVAD is FDA approved and commercially available for the treatment of ALL. The study doctor can explain how the study drugs are designed to work. Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.

Clinical Study Identifier: NCT02877303

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Elias Jabbour, MD

University of Texas MD Anderson Cancer Center
Houston, TX United States
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