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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01685021
Recruitment Status : Terminated
First Posted : September 13, 2012
Results First Posted : February 22, 2018
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
MorphoSys AG

Study Description
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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)

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Drug: MOR00208 (formerly Xmab5574) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : April 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MOR00208 (formerly Xmab5574)
intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody
 Drug: MOR00208 (formerly Xmab5574)
Other Name: MOR208


Outcome Measures
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Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Throughout during study until progression, after each treatment cycle ]

    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: Throughout during study until progression, after each treatment cycle ]
    Two patients had a response to treatment. For one of the two patients a progression was recorded, the other patient was censored due to an AE. Conse quently, the planned Kaplan-Meier analyses of response duration and time to hematological relapse could not be calculated.

  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 ]
    Number of patients with at least one treatment-emergent AE

  3. Pharmacokinetics of MOR00208 [ Time Frame: weekly, up to 16 weeks, based on samples taken Pre-dose (ie before infusion start) ]
    Steady State Trough Plasma Concentration (Cpre-dose) at 9th dose (infusion)

  4. Number of Patients Who Develop Ant-MOR00208 Antibodies as a Measure of Immunogenicity [ Time Frame: monthly, up to 7 months ]
  5. Safety Will be Evaluated by Assessing Adverse Events, Clinical Lab Data and Vital Signs, ECG, Physical Exam [ Time Frame: weekly, up to 7 months ]
    Number of patients with treatment-emergent AEs


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01685021


Locations
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United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43201
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
MorphoSys AG
Investigators
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Principal Investigator: 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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: MorphoSys AG
ClinicalTrials.gov Identifier: NCT01685021    
Other Study ID Numbers: MOR208C202
First Posted: September 13, 2012    Key Record Dates
Results First Posted: February 22, 2018
Last Update Posted: February 22, 2018
Last Verified: February 2018
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:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases