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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by MorphoSys AG
Sponsor:
Information provided by (Responsible Party):
MorphoSys AG
ClinicalTrials.gov Identifier:
NCT01685021
First received: September 3, 2012
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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)


Condition Intervention Phase
Acute Lymphoblastic Leukemia
Drug: MOR00208 (formerly Xmab5574)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IIa, Single-arm, Open-label Study of MOR00208, a Humanized Fc-Engineered Anti-CD19 Antibody, in Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL)

Resource links provided by NLM:


Further study details as provided by MorphoSys AG:

Primary Outcome Measures:
  • Overall response rate (ORR) [ Time Frame: 7 months ] [ Designated as safety issue: No ]

    ORR= CR (Complete Remission) + PR (Partial Remission)

    Antitumor activity of MOR00208



Secondary Outcome Measures:
  • 1. Patients response duration evaluation by hematology, bone marrow aspirates or biopsy, CT [ Time Frame: weekly, up to 7 months ] [ Designated as safety issue: No ]
  • 2. Safety will be evaluated by assessing adverse events, clinical lab data and vital signs, ECG, physical exam [ Time Frame: weekly, up to 7 months ] [ Designated as safety issue: Yes ]
  • 3. Pharmacokinetics of MOR00208 (Pharmacokinetic assessment comprises: Cmax, tmax, t 1/2, CL) [ Time Frame: weekly, up to 16 weeks ] [ Designated as safety issue: No ]
  • 4. Number of patients who develop ant-MOR00208 antibodies as a measure of immunogenicity [ Time Frame: monthly, up to 7 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MOR00208 (formerly Xmab5574)
intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody
Drug: MOR00208 (formerly Xmab5574)
Other Name: MOR208

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685021

Contacts
Contact: Roman Korolkiewicz +49 8989927 ext 0 info@morphosys.com

Locations
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43201
Contact: Rebecca Klisovic, MD    614-293-2268      
Principal Investigator: Rebecca Klisovic, MD         
United States, Tennessee
St. Jude Children's Research Hospital Not yet recruiting
Memphis, Tennessee, United States, 38105
Contact: Wing H. Leung, M.D., PhD    866-278-5833    info@stjude.org   
Principal Investigator: Wing H. Leung, M.D., PhD         
United States, Texas
University of Texas M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Susan O´Brian, MD    713-792-7543      
Principal Investigator: Susan O`Brian, MD         
Sponsors and Collaborators
MorphoSys AG
Investigators
Principal Investigator: Susan O´Brien, MD MDA
Principal Investigator: Rebecca Klisovic, MD Ohio State University
Principal Investigator: Wing H. Leung, M.D., PhD St. Jude Children's Research Hospital
  More Information

No publications provided

Responsible Party: MorphoSys AG
ClinicalTrials.gov Identifier: NCT01685021     History of Changes
Other Study ID Numbers: MOR208C202
Study First Received: September 3, 2012
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by MorphoSys AG:
B-ALL
CD19
MOR208
MOR00208
Xmab5574
B-cell acute lymphoblastic leukemia
Fc-optimized Anti-CD19 Antibody

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Burkitt Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, Non-Hodgkin
Lymphoma
Lymphoma, B-Cell
Neoplasms, Experimental
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014