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Trial record 3 of 7 for:    "XmAb 5574" OR "MOR208"

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 21, 2018
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
MorphoSys AG

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Lymphoblastic Leukemia
Intervention Drug: MOR00208 (formerly Xmab5574)
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MOR00208 (Formerly Xmab5574)
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intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody

MOR00208 (formerly Xmab5574)

Total Patients Screened: 30 Total patients Enrolled (at least one infusion with study treatment): 22

Period Title: Overall Study
Started 22
Completed 6 [1]
Not Completed 16
[1]
Last patient last visit date. Study was Terminated prematurely.
Arm/Group Title MOR00208 (Formerly Xmab5574)
Hide Arm/Group Description

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

MOR00208 (formerly Xmab5574)

Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
46.82  (17.098)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
10
  45.5%
Male
12
  54.5%
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 22 participants
29  (8.496)
1.Primary Outcome
Title Overall Response Rate (ORR)
Hide Description

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

Antitumor activity of MOR00208

Time Frame Throughout during study until progression, after each treatment cycle
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MOR00208 (Formerly Xmab5574)
Hide Arm/Group Description:

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

MOR00208 (formerly Xmab5574)

Total Patients Screened: 30 Total patients Enrolled (at least one infusion with study treatment): 22

Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: participants
2
2.Secondary Outcome
Title Patients Response Duration Evaluation by Hematology, Bone Marrow Aspirates or Biopsy, CT
Hide Description 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.
Time Frame Throughout during study until progression, after each treatment cycle
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MOR00208 (Formerly Xmab5574)
Hide Arm/Group Description:

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

MOR00208 (formerly Xmab5574)

Total Patients Screened: 30 Total patients Enrolled (at least one infusion with study treatment): 22

Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: days
Responder 1 56
Responder 2 28
3.Secondary Outcome
Title Safety Will be Evaluated by Assessing Adverse Events, Clinical Lab Data and Vital Signs, ECG, Physical Exam
Hide Description Number of patients with at least one treatment-emergent AE
Time Frame weekly, up to 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MOR00208 (Formerly Xmab5574)
Hide Arm/Group Description:

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

MOR00208 (formerly Xmab5574)

Total Patients Screened: 30 Total patients Enrolled (at least one infusion with study treatment): 22

Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: patients
22
4.Secondary Outcome
Title Pharmacokinetics of MOR00208
Hide Description Steady State Trough Plasma Concentration (Cpre-dose) at 9th dose (infusion)
Time Frame weekly, up to 16 weeks, based on samples taken Pre-dose (ie before infusion start)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title MOR00208 (Formerly Xmab5574)
Hide Arm/Group Description:

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

MOR00208 (formerly Xmab5574)

Total Patients Screened: 30 Total patients Enrolled (at least one infusion with study treatment): 22

Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: mcg/mL
198  (63.5)
5.Secondary Outcome
Title Number of Patients Who Develop Ant-MOR00208 Antibodies as a Measure of Immunogenicity
Hide Description [Not Specified]
Time Frame monthly, up to 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-MOR208 antibodies were not observed in any patients treated during this study.
Arm/Group Title MOR00208 (Formerly Xmab5574)
Hide Arm/Group Description:

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

MOR00208 (formerly Xmab5574)

Total Patients Screened: 30 Total patients Enrolled (at least one infusion with study treatment): 22

Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: patients
0
6.Secondary Outcome
Title Safety Will be Evaluated by Assessing Adverse Events, Clinical Lab Data and Vital Signs, ECG, Physical Exam
Hide Description Number of patients with treatment-emergent AEs
Time Frame weekly, up to 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MOR00208 (Formerly Xmab5574)
Hide Arm/Group Description:

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

MOR00208 (formerly Xmab5574)

Total Patients Screened: 30 Total patients Enrolled (at least one infusion with study treatment): 22

Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: number of patients with 1 or more AE
22
Time Frame From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Adverse Event Reporting Description Treatment-related Adverse Events
 
Arm/Group Title MOR00208 (Formerly Xmab5574)
Hide Arm/Group Description

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

MOR00208 (formerly Xmab5574)

Total Patients Screened: 30 Total patients Enrolled (at least one infusion with study treatment): 22

All-Cause Mortality
MOR00208 (Formerly Xmab5574)
Affected / at Risk (%)
Total   5/22 (22.73%) 
Show Serious Adverse Events Hide Serious Adverse Events
MOR00208 (Formerly Xmab5574)
Affected / at Risk (%)
Total   17/22 (77.27%) 
Blood and lymphatic system disorders   
Febrile Neutropenia * 1 [1]  4/22 (18.18%) 
Gastrointestinal disorders   
Diarrhoea * 1  2/22 (9.09%) 
General disorders   
Disease Progression * 1 [1]  6/22 (27.27%) 
Pyrexia * 1 [1]  5/22 (22.73%) 
Tumor lysis syndrome * 1  2/22 (9.09%) 
Infections and infestations   
Sepsis * 1 [1]  3/22 (13.64%) 
1
Term from vocabulary, MedDRA (15.1)
*
Indicates events were collected by non-systematic assessment
[1]
SAEs occuring in more than 2 patients in the study
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MOR00208 (Formerly Xmab5574)
Affected / at Risk (%)
Total   22/22 (100.00%) 
Blood and lymphatic system disorders   
Neutrophil count decreased  1  4/22 (18.18%) 
Anaemia  1  4/22 (18.18%) 
Platelet count decreased  1  4/22 (18.18%) 
White blood cell count decreased  1  2/22 (9.09%) 
Thrombocytopenia  1  2/22 (9.09%) 
Lymphopenia  1  1/22 (4.55%) 
Febrile neutropenia  1  1/22 (4.55%) 
Neutropenia  1  1/22 (4.55%) 
Cardiac disorders   
Hypertension  1  4/22 (18.18%) 
Sinus tachycardia  1  2/22 (9.09%) 
Bradycardia  1  1/22 (4.55%) 
Supraventricular tachycardia  1  1/22 (4.55%) 
Eye disorders   
Ocular hyperaemia  1  1/22 (4.55%) 
Vision blurred  1  1/22 (4.55%) 
Strabismus  1  1/22 (4.55%) 
Gastrointestinal disorders   
Constipation  1  6/22 (27.27%) 
Diarrhoea  1  4/22 (18.18%) 
Gastrooesophageal reflux disease  1  3/22 (13.64%) 
Vomiting  1  2/22 (9.09%) 
Proctalgia  1  1/22 (4.55%) 
Decreased appetite  1  1/22 (4.55%) 
Haemorrhoids  1  1/22 (4.55%) 
Lower gastrointestinal haemorrhage  1  1/22 (4.55%) 
Dyspepsia  1  1/22 (4.55%) 
Oropharyngeal pain  1  1/22 (4.55%) 
Gingival pain  1  1/22 (4.55%) 
Periodontal disease  1  1/22 (4.55%) 
Pharyngitis  1  1/22 (4.55%) 
Lip disorder  1  1/22 (4.55%) 
General disorders   
Infusion related reaction  1  13/22 (59.09%) 
Fatigue  1  9/22 (40.91%) 
Nausea  1  6/22 (27.27%) 
Abdominal pain  1  4/22 (18.18%) 
Pyrexia  1  4/22 (18.18%) 
Epistaxis  1  3/22 (13.64%) 
Chills  1  3/22 (13.64%) 
Oedema peripheral  1  3/22 (13.64%) 
Confusional state  1  3/22 (13.64%) 
Oedema  1  3/22 (13.64%) 
Agitation  1  2/22 (9.09%) 
Presyncope  1  2/22 (9.09%) 
Mucosal inflammation  1  2/22 (9.09%) 
Oral pain  1  1/22 (4.55%) 
Chest discomfort  1  1/22 (4.55%) 
Lymphoedema  1  1/22 (4.55%) 
Myalgia  1  1/22 (4.55%) 
Tremor  1  1/22 (4.55%) 
Abdominal distension  1  1/22 (4.55%) 
Dysgeusia  1  1/22 (4.55%) 
Flushing  1  1/22 (4.55%) 
Dysphonia  1  1/22 (4.55%) 
Hyperhidrosis  1  1/22 (4.55%) 
Weight increased  1  1/22 (4.55%) 
Malaise  1  1/22 (4.55%) 
Migraine  1  1/22 (4.55%) 
Lymph node pain  1  1/22 (4.55%) 
Tumour lysis syndrome  1  1/22 (4.55%) 
Weight decreased  1  1/22 (4.55%) 
Swelling face  1  1/22 (4.55%) 
Lethargy  1  1/22 (4.55%) 
Pain in extremity  1  1/22 (4.55%) 
Asthenia  1  1/22 (4.55%) 
Allergic transfusion reaction  1  1/22 (4.55%) 
Leukaemic infiltration  1  1/22 (4.55%) 
Hepatobiliary disorders   
Aspartate aminotransferase increased  1  5/22 (22.73%) 
Alanine aminotransferase increased  1  4/22 (18.18%) 
Gamma-glutamyltransferase increased  1  4/22 (18.18%) 
Hepatorenal syndrome  1  1/22 (4.55%) 
Immune system disorders   
Graft versus host disease  1  1/22 (4.55%) 
Infections and infestations   
Cytomegalovirus viraemia  1  1/22 (4.55%) 
Hepatitis viral  1  1/22 (4.55%) 
Sepsis  1  1/22 (4.55%) 
Urinary tract infection  1  1/22 (4.55%) 
Device related infection  1  1/22 (4.55%) 
Lung infection  1  1/22 (4.55%) 
Infection  1  1/22 (4.55%) 
Wound infection  1  1/22 (4.55%) 
Alpha haemolytic streptococcal infection  1  1/22 (4.55%) 
Corynebacterium infection  1  1/22 (4.55%) 
Injury, poisoning and procedural complications   
Contusion  1  3/22 (13.64%) 
Subdural haematoma  1  1/22 (4.55%) 
Fall  1  1/22 (4.55%) 
Investigations   
Blood albumin decreased  1  1/22 (4.55%) 
Blood amylase increased  1  1/22 (4.55%) 
International normalised ratio increased  1  1/22 (4.55%) 
Blood alkaline phosphatase increased  1  1/22 (4.55%) 
Hypoalbuminaemia  1  1/22 (4.55%) 
Metabolism and nutrition disorders   
Hypokalaemia  1  6/22 (27.27%) 
Hyperglycaemia  1  6/22 (27.27%) 
Hyperkalaemia  1  5/22 (22.73%) 
Hypocalcaemia  1  4/22 (18.18%) 
Hypomagnesaemia  1  4/22 (18.18%) 
Blood glucose increased  1  1/22 (4.55%) 
Blood magnesium decreased  1  1/22 (4.55%) 
Acidosis  1  1/22 (4.55%) 
Hypoglycaemia  1  1/22 (4.55%) 
Hyponatraemia  1  1/22 (4.55%) 
Hypophosphataemia  1  1/22 (4.55%) 
Hyperphosphataemia  1  1/22 (4.55%) 
Metabolic acidosis  1  1/22 (4.55%) 
Musculoskeletal and connective tissue disorders   
Muscular weakness  1  3/22 (13.64%) 
Joint range of motion decreased  1  1/22 (4.55%) 
Bone pain  1  1/22 (4.55%) 
Back pain  1  1/22 (4.55%) 
Nervous system disorders   
Paraesthesia  1  3/22 (13.64%) 
Headache  1  3/22 (13.64%) 
Dizziness  1  2/22 (9.09%) 
Brachial plexopathy  1  1/22 (4.55%) 
Syncope  1  1/22 (4.55%) 
Trigeminal nerve disorder  1  1/22 (4.55%) 
Encephalopathy  1  1/22 (4.55%) 
Dyskinesia  1  1/22 (4.55%) 
Intracranial pressure increased  1  1/22 (4.55%) 
Psychiatric disorders   
Insomnia  1  2/22 (9.09%) 
Anxiety  1  2/22 (9.09%) 
Depression  1  1/22 (4.55%) 
Renal and urinary disorders   
Blood creatinine increased  1  2/22 (9.09%) 
Pollakiuria  1  2/22 (9.09%) 
Renal failure acute  1  2/22 (9.09%) 
Renal failure  1  2/22 (9.09%) 
Hyperuricaemia  1  2/22 (9.09%) 
Haematuria  1  1/22 (4.55%) 
Cystitis  1  1/22 (4.55%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  5/22 (22.73%) 
Cough  1  4/22 (18.18%) 
Upper-airway cough syndrome  1  2/22 (9.09%) 
Pleural effusion  1  2/22 (9.09%) 
Pleuritic pain  1  1/22 (4.55%) 
Productive cough  1  1/22 (4.55%) 
Atelectasis  1  1/22 (4.55%) 
Hypoxia  1  1/22 (4.55%) 
Sinusitis  1  1/22 (4.55%) 
Dyspnoea exertional  1  1/22 (4.55%) 
Nasal congestion  1  1/22 (4.55%) 
Pneumonia  1  1/22 (4.55%) 
Chest pain  1  1/22 (4.55%) 
Skin and subcutaneous tissue disorders   
Rash maculo-papular  1  1/22 (4.55%) 
Rash erythematous  1  1/22 (4.55%) 
Vascular disorders   
Hypotension  1  2/22 (9.09%) 
Petechiae  1  1/22 (4.55%) 
Haemangioma of liver  1  1/22 (4.55%) 
1
Term from vocabulary, MedDRA (15.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
As specified in the respective clinical trial agreements with the PI.
Results Point of Contact
Name/Title: Dr. Sumeet Ambarkhane, Director, Clinical Program Leader
Organization: MorphoSys AG
Phone: 004989899270
Responsible Party: MorphoSys AG
ClinicalTrials.gov Identifier: NCT01685021     History of Changes
Other Study ID Numbers: MOR208C202
First Submitted: September 3, 2012
First Posted: September 13, 2012
Results First Submitted: March 4, 2016
Results First Posted: February 21, 2018
Last Update Posted: February 21, 2018