study of fc-optimized anti-cd19 antibody (mor00208) to treat b-cell acute lymphoblastic leukemia(b-all)

Conditions: Acute Lymphoblastic Leukemia

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

Keywords: b-all cd19 mor208 mor00208 xmab5574 b-cell acute lymphoblastic leukemia fc-optimized anti-cd19 antibody