Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat B-cell Acute Lymphoblastic Leukemia(B-ALL)
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: MOR00208 (formerly Xmab5574)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: B-ALL; CD19; MOR208; MOR00208; Xmab5574; B-cell acute lymphoblastic leukemia; Fc-optimized Anti-CD19 Antibody

Summary:

      This is an open-label, multicentre study to characterize the safety and preliminary efficacy
      of the human anti CD19 antibody MOR00208 in adult subjects with relapsed/refractory B-cell
      acute lymphoblastic leukemia (B-ALL)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with previously treated Philadelphia-chromosome-negative B-ALL, with
             progression after at least one prior therapy. Patients with
             Philadelphia-chromosome-positive B-ALL can only be included if they are refractory or
             intolerant to at least one tyrosine-kinase-inhibitor.

          -  Male or female patients at least 16 years of age; if the patient is less than 18 years
             of age, the patient must have the ability to understand and give written assent in
             addition to the parent's/guardian's written informed consent.

          -  Patients with histologically confirmed diagnosis of B-ALL

          -  Mixed phenotype acute leukemia patients who have B cell immunophenotype.

          -  Patients with an Eastern Cooperative Oncology Group performance status of less than or
             equal to 2

          -  Patients with a total bilirubin of less than or equal to 2.0 mg/dL

          -  Patients with alanine aminotransferase or aspartate aminotransferase less than or
             equal to 2.5 times the upper limit of normal

          -  Patients with a creatinine level of less than or equal to 2.0 mg/dL

          -  If a female of childbearing potential, confirmation of a negative pregnancy test
             before enrollment and use of double-barrier contraception, confirmation of a negative
             pregnancy test before enrollment and use of oral contraceptive plus barrier
             contraceptive, or confirmation of having undergone clinically documented total
             hysterectomy, oophorectomy, or tubal ligation

          -  If a male, use of an effective barrier method of contraception during the study and
             for 3 months after the last dose if sexually active with a female of childbearing
             potential

          -  Patients with the ability to understand and give written informed consent and to
             comply with the study protocol

        Exclusion Criteria:

          -  Patients who received previous treatment with an anti-CD19 antibody or fragments

          -  Receipt of anti-CD20 therapy no greater than 4 weeks before the first study dose

          -  Patients having undergone prior allogeneic stem cell transplantation within 3 months
             or having active graft versus host disease

          -  Patients with known hypersensitivity to any excipient contained in the drug
             formulation

          -  Patients with a New York Heart Association Class III or IV

          -  History of stroke or myocardial infarction within the last 6 months

          -  Patients with a history of positive human immunodeficiency virus test result (ELISA or
             western blot)

          -  Patients with positive hepatitis serology. Hepatitis B (HBV): Patients with positive
             serology for hepatitis B, defined as positive for hepatitis B surface antigen (HbsAg)
             or total anti-hepatitis B core antibody (anti-Hbc). Patients positive for anti- Hbc
             may be included if hepatitis B viral DNA is not detectable. Hepatitis C (HCV):
             Patients with positive hepatitis C serology (defined as positive for anti-hepatitis C
             virus antibody (anti-HCV) unless HCV-RNA is confirmed negative.

          -  Patients with active viral, bacterial, or systemic fungal infection requiring active
             parenteral treatment

          -  Patients who are receiving active treatment/chemotherapy for another primary
             malignancy or have received any treatment, including surgery, radiation, or
             chemotherapy, within the past 5 years (except ductal breast cancer in situ, for
             nonmelanoma skin cancer, prostate cancer not requiring treatment, and cervical
             carcinoma in situ)

          -  Patients who are pregnant or breastfeeding

          -  Patients with major surgery or radiation therapy within 4 weeks prior to first study
             dose