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

NCT ID: NCT01685021

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-03-31

Brief 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)

Conditions

Acute Lymphoblastic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MOR00208 (formerly Xmab5574)

intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody

Group Type: EXPERIMENTAL

MOR00208 (formerly Xmab5574)

Intervention Type: DRUG

Interventions

MOR00208 (formerly Xmab5574)

Intervention Type: DRUG

Other Intervention Names

MOR208

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MorphoSys AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elias Jabbour, MD

Role: PRINCIPAL_INVESTIGATOR

MDA

Rebecca Klisovic, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Wing H. Leung, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

Ohio State University Medical Center

Columbus, Ohio, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

Countries

United States

References

Klisovic RB, Leung WH, Brugger W, Dirnberger-Hertweck M, Winderlich M, Ambarkhane SV, Jabbour EJ. A phase 2a, single-arm, open-label study of tafasitamab, a humanized, Fc-modified, anti-CD19 antibody, in patients with relapsed/refractory B-precursor cell acute lymphoblastic leukemia. Cancer. 2021 Nov 15;127(22):4190-4197. doi: 10.1002/cncr.33796. Epub 2021 Aug 3.

Reference Type: DERIVED

PMID: 34343354 (View on PubMed)

Other Identifiers

MOR208C202

Identifier Type: -

Identifier Source: org_study_id