Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 2

Summary: 
      You are being asked to take part in this study because you either had Ph positive B-lineage
      acute lymphoblastic leukemia (ALL) or still have a small amount of the disease and recently
      received an allogeneic stem cell transplant (cells from someone else).

      The goal of this clinical research study is to learn if blinatumomab in patients who have had
      an allogeneic stem cell transplant can help to control ALL or prevent ALL from coming back in
      patients who either have a small amount of ALL or have had ALL in the past. The safety of
      this drug will also be studied.
    

Detailed description: 
      Study Drug Administration:

      Every study cycle will be 6 weeks. You may receive up to 4 cycles of blinatumomab. Each cycle
      will start around 3, 6, 9, and 12 months after your stem cell transplant.

      In each cycle, you will receive blinatumomab as a continuous infusion by vein for 4 weeks,
      followed by a 2 week "rest period" during which you will not receive blinatumomab.

      You will need to remain in the hospital for the first 2 cycles so that you can be checked on
      for side effects.

      Length of Study:

      You may receive blinatumomab for up to 1 year. You will no longer be able to receive the
      study drug if the disease comes back (if you do not have ALL), if the disease gets worse (if
      you have a small amount of ALL), if intolerable side effects occur, or if you are unable to
      follow study directions.

      Study Visits:

      Before each cycle:

        -  You will have a physical exam. As part of the physical exam, you will be checked for
           graft versus host disease (GVHD, when transplanted donor tissue attacks the tissues of
           the recipient's body).

        -  Blood (about 4 tablespoons) will be drawn to learn the effectiveness of the stem cell
           transplant.

        -  You will have a bone marrow biopsy and aspiration to check the status of the disease and
           for cytogenetic testing.

      Once a week during each cycle, blood (about 4 tablespoons) will be drawn for routine tests.

      End of Study Visit:

      About 2 weeks after your last dose of blinatumomab:

        -  You will have a physical exam.

        -  Blood (about 4 tablespoons) will be drawn to learn the effectiveness of the stem cell
           transplant.

        -  You will have a bone marrow biopsy and aspiration to check the status of the disease and
           for cytogenetic testing.

      This is an investigational study. Blinatumomab is FDA approved and commercially available for
      the treatment of Philadelphia chromosome (Ph) negative B-ALL that has returned after
      treatment. Its use in patients with Ph positive B-lineage ALL is investigational.

      Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.
    

Intervention name(s): Blinatumomab; Hematopoietic Cell Transplantation
Intervention type(s): Drug; Procedure
Intervention description(s): Participants receive Blinatumomab as continuous intravenous infusion at a dose of 28 µg/24 hours over 4 weeks followed by a treatment-free period of 2 weeks, defined as one 6-week treatment cycle. In the first induction cycle, the initial dose of Blinatumomab is 9 µg/day for the first 7 days of treatment which then will be escalated (dose step) to 28 µg/day starting on day 8 (week 2) through day 29 (week 4). For all subsequent cycles, 28 µg/day is the dose for all 4 weeks of continuous treatment. Participants receive 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT).; Hematopoietic progenitor cell infusion
Other intervention name(s): Blincyto; HCT
Intervention MeSH terms: Blinatumomab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Lymphoblastic Leukemia; ALL; B-lineage Acute Lymphoblastic Leukemia; Malignant neoplasms stated as primary lymphoid haematopoietic; Blinatumomab; Blincyto; Post allogeneic stem cell transplant