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
Intervention: Blinatumomab; Hematopoietic Cell Transplantation
Intervention description: 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
Intervention MeSH terms: Blinatumomab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 1 Year
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Acute Lymphoblastic Leukemia; ALL; B-lineage Acute Lymphoblastic Leukemia; Malignant neoplasms stated as primary lymphoid haematopoietic; Blinatumomab; Blincyto; Post allogeneic stem cell transplant

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients 1-70 years of age.

          2. Patients with B-lineage ALL in a) hematologic complete remission (CR) beyond CR1 at
             time of transplant; patients beyond CR1 or with primary induction failure may be
             without minimal residual disease, b) any residual disease defined by positive flow
             >0.01%, detection of BCR-ABL transcript by PCR with a sensitivity of 1/10,000, or
             detection of the t(9;22) translocation in any metaphases by cytogenetics at time of
             transplant, or presence of the MLL gene.

          3. Received an allogeneic HCT within the last 100 days. Enrollment within 30-100 days
             after transplant, and after adequate recovery of counts defined as ANC >/= 0.5 x
             10^9/L without daily use of myeloid growth factor and platelet > 20 x 10^9/L without
             platelet transfusion within 1 week, and adequate organ function to receive
             blinatumomab defined as creatinine clearance greater than 30 ml/min, ALT/AST < 5 x ULN
             and serum bilirubin < 3 x ULN.

          4. Performance status of 0, 1, or 2. Karnofsky (or Lansky for subjects < 16 years old)
             performance status >/= 50.

        Exclusion Criteria:

          1. Relapsed ALL defined as >5% malignant blasts in bone marrow or peripheral blood.

          2. Active GVHD requiring systemic steroid therapy. Medications for GVHD prophylaxis are
             acceptable.

          3. Systemic steroid therapy unless for physiologic replacement

          4. Uncontrolled disease/infection as judged by the treating physician

          5. Active ALL in the central nervous system (CNS), as defined by >/= 5 leukocytes per
             microL with identifiable blast cells in the CSF, and/or the presence of cranial-nerve
             palsies

          6. Pregnant or nursing women