Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat B-cell Acute Lymphoblastic Leukemia(B-ALL)

MorphoSys

Status and phase

Terminated

Phase 2

Conditions

Acute Lymphoblastic Leukemia

Treatments

Drug: MOR00208 (formerly Xmab5574)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01685021

MOR208C202

Details and patient eligibility

About

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)

Enrollment

22 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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