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

NCT01685021 | Terminated Phase 2 Results

• 1 other identifier: MOR208C202
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

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

Keywords

B-ALL; CD19; MOR208; MOR00208; Xmab5574; B-cell acute lymphoblastic leukemia; Fc-optimized Anti-CD19 Antibody

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR= CR (Complete Remission) + PR (Partial Remission) Antitumor activity of MOR00208

  Throughout during study until progression, after each treatment cycle

Secondary Outcomes (5)

• Patients Response Duration Evaluation by Hematology, Bone Marrow Aspirates or Biopsy, CT

  Throughout during study until progression, after each treatment cycle

• Safety Will be Evaluated by Assessing Adverse Events, Clinical Lab Data and Vital Signs, ECG, Physical Exam

  weekly, up to 7 months

• Pharmacokinetics of MOR00208

  weekly, up to 16 weeks, based on samples taken Pre-dose (ie before infusion start)

• Number of Patients Who Develop Ant-MOR00208 Antibodies as a Measure of Immunogenicity

  monthly, up to 7 months

• Safety Will be Evaluated by Assessing Adverse Events, Clinical Lab Data and Vital Signs, ECG, Physical Exam

  weekly, up to 7 months

Study Arms (1)

MOR00208 (formerly Xmab5574)

EXPERIMENTAL

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

Drug: MOR00208 (formerly Xmab5574)

Interventions

MOR00208 (formerly Xmab5574) DRUG

Also known as: MOR208

MOR00208 (formerly Xmab5574)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MorphoSys AG: lead

Study Sites (3)

Ohio State University Medical Center

Columbus, Ohio, 43201, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 34343354 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Burkitt Lymphoma

Interventions

tafasitamab

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma

Results Point of Contact

• Title: Dr. Sumeet Ambarkhane, Director, Clinical Program Leader
• Organization: MorphoSys AG

sumeet.ambarkhane@morphosys.com

004989899270

Study Officials

• Elias Jabbour, MD

  MDA

  PRINCIPAL INVESTIGATOR

• Rebecca Klisovic, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Wing H. Leung, M.D., PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2012
• First Posted: September 13, 2012
• Study Start: April 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: February 22, 2018
• Results First Posted: February 22, 2018

Record last verified: 2018-02

Locations

US (3)