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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

Tracking Information
First Submitted Date  ICMJE September 3, 2012
First Posted Date  ICMJE September 13, 2012
Results First Submitted Date  ICMJE March 4, 2016
Results First Posted Date  ICMJE February 22, 2018
Last Update Posted Date February 22, 2018
Study Start Date  ICMJE April 2013
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2018)		 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2012)		 Overall response rate (ORR) [ Time Frame: 7 months ]
ORR= CR (Complete Remission) + PR (Partial Remission) Antitumor activity of MOR00208
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2018)
  • 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.
  • 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
  • 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)
  • Number of Patients Who Develop Ant-MOR00208 Antibodies as a Measure of Immunogenicity [ Time Frame: monthly, up to 7 months ]
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2012)
  • 1. Patients response duration evaluation by hematology, bone marrow aspirates or biopsy, CT [ Time Frame: weekly, up to 7 months ]
  • 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. Pharmacokinetics of MOR00208 (Pharmacokinetic assessment comprises: Cmax, tmax, t 1/2, CL) [ Time Frame: weekly, up to 16 weeks ]
  • 4. Number of patients who develop ant-MOR00208 antibodies as a measure of immunogenicity [ Time Frame: monthly, up to 7 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat B-cell Acute Lymphoblastic Leukemia(B-ALL)
Official Title  ICMJE 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)
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Lymphoblastic Leukemia
Intervention  ICMJE Drug: MOR00208 (formerly Xmab5574)
Other Name: MOR208
Study Arms  ICMJE Experimental: MOR00208 (formerly Xmab5574)
intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody
Intervention: Drug: MOR00208 (formerly Xmab5574)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 27, 2015)		 22
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2012)		 30
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01685021
Other Study ID Numbers  ICMJE MOR208C202
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party MorphoSys AG
Original Responsible Party Same as current
Current Study Sponsor  ICMJE MorphoSys AG
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account MorphoSys AG
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP