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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

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

MorphoSys AG

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Acute Lymphoblastic Leukemia
Intervention	Drug: MOR00208 (formerly Xmab5574)
Enrollment	22

Participant Flow

Recruitment Details
Pre-assignment Details


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

Baseline Characteristics

Arm/Group Title		MOR00208 (Formerly Xmab5574)
Arm/Group Description		intravenous Infusion of MOR00208, F...
Arm/Group Description		intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody MOR00208 (formerly Xmab5574)
Overall Number of Baseline Participants		22
Baseline Analysis Population Description		[Not Specified]
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)

Outcome Measures

1.Primary Outcome


Title	Overall Response Rate (ORR)
Description	ORR= CR (Complete Remission) + PR (Partial Remission) ...
Description	ORR= CR (Complete Remission) + PR (Partial Remission) Antitumor activity of MOR00208
Time Frame	Throughout during study until progression, after each treatment cycle

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	MOR00208 (Formerly Xmab5574)
Arm/Group Description:	intravenous Infusion of MOR00208, F...
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
Description	Two patients had a response to treatment. For one of the two patients ...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	MOR00208 (Formerly Xmab5574)
Arm/Group Description:	intravenous Infusion of MOR00208, F...
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
Description	Number of patients with at least one treatment-emergent AE
Description	Number of patients with at least one treatment-emergent AE
Time Frame	weekly, up to 7 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	MOR00208 (Formerly Xmab5574)
Arm/Group Description:	intravenous Infusion of MOR00208, F...
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
Description	Steady State Trough Plasma Concentration (Cpre-dose) at 9th dose (infu...
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	MOR00208 (Formerly Xmab5574)
Arm/Group Description:	intravenous Infusion of MOR00208, F...
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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	monthly, up to 7 months

Outcome Measure Data

Analysis Population Description

Anti-MOR208 antibodies were not observed in any patients treated during this study.


Arm/Group Title	MOR00208 (Formerly Xmab5574)
Arm/Group Description:	intravenous Infusion of MOR00208, F...
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
Description	Number of patients with treatment-emergent AEs
Description	Number of patients with treatment-emergent AEs
Time Frame	weekly, up to 7 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	MOR00208 (Formerly Xmab5574)
Arm/Group Description:	intravenous Infusion of MOR00208, F...
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

Adverse Events

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)
Arm/Group Description	intravenous Infusion of MOR00208, F...
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%)
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

More Information

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

Layout table for Results Point of Contact information

Name/Title:	Dr. Sumeet Ambarkhane, Director, Clinical Program Leader
Organization:	MorphoSys AG
Phone:	004989899270
EMail:	sumeet.ambarkhane@morphosys.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Layout table for additonal information

Responsible Party:	MorphoSys AG
ClinicalTrials.gov Identifier:	NCT01685021
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 22, 2018
Last Update Posted:	February 22, 2018