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History of Changes for Study: NCT01685021
Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat B-cell Acute Lymphoblastic Leukemia(B-All)
Latest version (submitted February 20, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 10, 2012 None (earliest Version on record)
2 October 9, 2012 Contacts/Locations and Study Status
3 January 7, 2013 Study Status and Oversight
4 April 29, 2013 Recruitment Status, Study Status, Contacts/Locations, Study Identification, Eligibility and Oversight
5 July 24, 2013 Contacts/Locations and Study Status
6 March 7, 2014 Study Status and Contacts/Locations
7 March 10, 2014 Study Status
8 May 19, 2014 Contacts/Locations, Study Status and Eligibility
9 October 21, 2014 Study Status and Contacts/Locations
10 April 27, 2015 Recruitment Status, Study Status, Contacts/Locations, Study Design
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Results Submission Events
11 February 20, 2018 Study Status, Outcome Measures and Results
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Study NCT01685021
Submitted Date:  September 10, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: MOR208C202
Brief Title: Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat B-cell Acute Lymphoblastic Leukemia(B-All)
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)
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2012
Overall Status: Not yet recruiting
Study Start: December 2012
Primary Completion: July 2014 [Anticipated]
Study Completion: October 2014 [Anticipated]
First Submitted: September 3, 2012
First Submitted that
Met QC Criteria:
September 10, 2012
First Posted: September 13, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 10, 2012
Last Update Posted: September 13, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: MorphoSys AG
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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)
Detailed Description:
Open or close this module Conditions
Conditions: Acute Lymphoblastic Leukemia
Keywords: B-ALL
CD19
MOR208
MOR00208
Xmab5574
B-cell acute lymphoblastic leukemia
Fc-optimized Anti-CD19 Antibody
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: MOR00208 (formerly Xmab5574)
intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody
Drug: MOR00208 (formerly Xmab5574)
Other Names:
  • MOR208
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Overall response rate (ORR)
[ Time Frame: 7 months ]

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

Antitumor activity of MOR00208

Secondary Outcome Measures:
1. 1. Patients response duration evaluation by hematology, bone marrow aspirates or biopsy, CT
[ Time Frame: weekly, up to 7 months ]

2. 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 ]

3. 3. Pharmacokinetics of MOR00208 (Pharmacokinetic assessment comprises: Cmax, tmax, t 1/2, CL)
[ Time Frame: weekly, up to 16 weeks ]

4. 4. Number of patients who develop ant-MOR00208 antibodies as a measure of immunogenicity
[ Time Frame: monthly, up to 7 months ]

Open or close this module Eligibility
Minimum Age: 16 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Patients with previously treated B-ALL, with progression after at least 1 prior therapy
  2. 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.
  3. Patients with histologically confirmed diagnosis of B-ALL
  4. Mixed phenotype acute leukemia patients who have B cell immunophenotype.
  5. Patients with a white blood cell count less than 30000/mm3 (Note: This criterion can be removed if 3 of the first 5 patients show no marked increase in blast count or tumor lysis syndrome.)
  6. Patients with an Eastern Cooperative Oncology Group performance status of less than or equal to 2
  7. Patients with a total bilirubin of less than or equal to 2.0 mg/dL
  8. Patients with alanine aminotransferase or aspartate aminotransferase less than or equal to 2.5 times the upper limit of normal
  9. Patients with a creatinine level of less than or equal to 2.0 mg/dL
  10. 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
  11. 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
  12. Patients with the ability to understand and give written informed consent and to comply with the study protocol

Exclusion Criteria:

  1. Patients who received previous treatment with an anti-CD19 antibody or fragments
  2. Receipt of anti-CD20 therapy no greater than 4 weeks before the first study dose
  3. Patients having undergone prior allogeneic stem cell transplantation within 3 months or having active graft versus host disease
  4. Patients with known hypersensitivity to any excipient contained in the drug formulation
  5. Patients with a New York Heart Association Class III or IV
  6. History of stroke or myocardial infarction within the last 6 months
  7. Patients with a history of positive human immunodeficiency virus test result (ELISA or western blot)
  8. Patients with clinical or laboratory evidence of active hepatitis B (positive hepatitis B surface antigen with negative hepatitis B surface antibody) or hepatitis C (positive hepatitis C virus [HCV] antibody and detectable HCV ribonucleic acid with alanine aminotransferase above normal range)
  9. Patients with active viral, bacterial, or systemic fungal infection requiring active parenteral treatment
  10. Patients who are receiving active treatment/chemotherapy for another primary malignancy 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)
  11. Patients who are pregnant or breastfeeding
  12. Patients with major surgery or radiation therapy within 4 weeks prior to first study dose
Open or close this module Contacts/Locations
Central Contact Person: Thomas Schell
Telephone: +49 8989927 Ext. 0
Study Officials: Susan O´Brian, MD
Principal Investigator
MDA
Rebecca Klisovic, MD
Principal Investigator
Ohio State University
Locations: United States, Ohio
Columbus, Ohio, United States
United States, Texas
Houston, Texas, United States
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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