Trial Outcomes & Findings for Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat B-cell Acute Lymphoblastic Leukemia(B-ALL) (NCT NCT01685021)
NCT ID: NCT01685021
Last Updated: 2018-02-22
Results Overview
ORR= CR (Complete Remission) + PR (Partial Remission) Antitumor activity of MOR00208
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Throughout during study until progression, after each treatment cycle
Results posted on
2018-02-22
Participant Flow
Participant milestones
| Measure |
MOR00208 (Formerly Xmab5574)
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 Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat B-cell Acute Lymphoblastic Leukemia(B-ALL)
Baseline characteristics by cohort
| Measure |
MOR00208 (Formerly Xmab5574)
n=22 Participants
intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody
MOR00208 (formerly Xmab5574)
|
|---|---|
|
Age, Continuous
|
46.82 years
STANDARD_DEVIATION 17.098 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Body Mass Index
|
29 kg/m2
STANDARD_DEVIATION 8.496 • n=5 Participants
|
PRIMARY outcome
Timeframe: Throughout during study until progression, after each treatment cycleORR= CR (Complete Remission) + PR (Partial Remission) Antitumor activity of MOR00208
Outcome measures
| Measure |
MOR00208 (Formerly Xmab5574)
n=22 Participants
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 Response Rate (ORR)
|
2 participants
|
SECONDARY outcome
Timeframe: Throughout during study until progression, after each treatment cycleTwo 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.
Outcome measures
| Measure |
MOR00208 (Formerly Xmab5574)
n=22 Participants
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
|
|---|---|
|
Patients Response Duration Evaluation by Hematology, Bone Marrow Aspirates or Biopsy, CT
Responder 1
|
56 days
|
|
Patients Response Duration Evaluation by Hematology, Bone Marrow Aspirates or Biopsy, CT
Responder 2
|
28 days
|
SECONDARY outcome
Timeframe: weekly, up to 7 monthsNumber of patients with at least one treatment-emergent AE
Outcome measures
| Measure |
MOR00208 (Formerly Xmab5574)
n=22 Participants
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
|
|---|---|
|
Safety Will be Evaluated by Assessing Adverse Events, Clinical Lab Data and Vital Signs, ECG, Physical Exam
|
22 patients
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
MOR00208 (Formerly Xmab5574)
n=22 Participants
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
|
|---|---|
|
Pharmacokinetics of MOR00208
|
198 mcg/mL
Standard Deviation 63.5
|
SECONDARY outcome
Timeframe: monthly, up to 7 monthsPopulation: Anti-MOR208 antibodies were not observed in any patients treated during this study.
Outcome measures
| Measure |
MOR00208 (Formerly Xmab5574)
n=22 Participants
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
|
|---|---|
|
Number of Patients Who Develop Ant-MOR00208 Antibodies as a Measure of Immunogenicity
|
0 patients
|
SECONDARY outcome
Timeframe: weekly, up to 7 monthsNumber of patients with treatment-emergent AEs
Outcome measures
| Measure |
MOR00208 (Formerly Xmab5574)
n=22 Participants
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
|
|---|---|
|
Safety Will be Evaluated by Assessing Adverse Events, Clinical Lab Data and Vital Signs, ECG, Physical Exam
|
22 number of patients with 1 or more AE
|
Adverse Events
MOR00208 (Formerly Xmab5574)
Serious events: 17 serious events
Other events: 22 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
MOR00208 (Formerly Xmab5574)
n=22 participants at risk
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
|
|---|---|
|
General disorders
Disease Progression
|
27.3%
6/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Pyrexia
|
22.7%
5/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
18.2%
4/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Infections and infestations
Sepsis
|
13.6%
3/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Tumor lysis syndrome
|
9.1%
2/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
2/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
Other adverse events
| Measure |
MOR00208 (Formerly Xmab5574)
n=22 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
27.3%
6/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
27.3%
6/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Nausea
|
27.3%
6/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
22.7%
5/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.7%
5/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
22.7%
5/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
18.2%
4/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Infusion related reaction
|
59.1%
13/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Fatigue
|
40.9%
9/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
27.3%
6/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Abdominal pain
|
18.2%
4/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Gastrointestinal disorders
Diarrhoea
|
18.2%
4/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Pyrexia
|
18.2%
4/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
18.2%
4/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
18.2%
4/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Blood and lymphatic system disorders
Anaemia
|
18.2%
4/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
4/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
18.2%
4/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Cardiac disorders
Hypertension
|
18.2%
4/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Hepatobiliary disorders
Gamma-glutamyltransferase increased
|
18.2%
4/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
18.2%
4/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Epistaxis
|
13.6%
3/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Chills
|
13.6%
3/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
13.6%
3/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Nervous system disorders
Paraesthesia
|
13.6%
3/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Oedema peripheral
|
13.6%
3/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Nervous system disorders
Headache
|
13.6%
3/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Injury, poisoning and procedural complications
Contusion
|
13.6%
3/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
13.6%
3/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Confusional state
|
13.6%
3/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Oedema
|
13.6%
3/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Blood and lymphatic system disorders
White blood cell count decreased
|
9.1%
2/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Renal and urinary disorders
Blood creatinine increased
|
9.1%
2/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Renal and urinary disorders
Pollakiuria
|
9.1%
2/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Renal and urinary disorders
Renal failure acute
|
9.1%
2/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Vascular disorders
Hypotension
|
9.1%
2/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
2/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Agitation
|
9.1%
2/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Nervous system disorders
Dizziness
|
9.1%
2/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Psychiatric disorders
Insomnia
|
9.1%
2/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Psychiatric disorders
Anxiety
|
9.1%
2/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.1%
2/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Presyncope
|
9.1%
2/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Cardiac disorders
Sinus tachycardia
|
9.1%
2/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
9.1%
2/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.1%
2/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Renal and urinary disorders
Renal failure
|
9.1%
2/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Mucosal inflammation
|
9.1%
2/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Renal and urinary disorders
Hyperuricaemia
|
9.1%
2/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Eye disorders
Ocular hyperaemia
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Investigations
Blood albumin decreased
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Renal and urinary disorders
Haematuria
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Investigations
Blood amylase increased
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Oral pain
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Chest discomfort
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Gastrointestinal disorders
Proctalgia
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Gastrointestinal disorders
Decreased appetite
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Renal and urinary disorders
Cystitis
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Infections and infestations
Cytomegalovirus viraemia
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Metabolism and nutrition disorders
Blood magnesium decreased
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Immune system disorders
Graft versus host disease
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Infections and infestations
Hepatitis viral
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Investigations
International normalised ratio increased
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Lymphoedema
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Myalgia
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Infections and infestations
Sepsis
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Tremor
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Infections and infestations
Urinary tract infection
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Abdominal distension
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Dysgeusia
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Flushing
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Dysphonia
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Vascular disorders
Petechiae
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Metabolism and nutrition disorders
Acidosis
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Eye disorders
Vision blurred
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Hyperhidrosis
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Eye disorders
Strabismus
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Infections and infestations
Device related infection
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Weight increased
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Nervous system disorders
Brachial plexopathy
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Malaise
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Nervous system disorders
Syncope
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Migraine
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Lymph node pain
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Cardiac disorders
Bradycardia
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Psychiatric disorders
Depression
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Injury, poisoning and procedural complications
Fall
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Infections and infestations
Lung infection
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Vascular disorders
Haemangioma of liver
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Tumour lysis syndrome
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Weight decreased
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Swelling face
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Gastrointestinal disorders
Gingival pain
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Gastrointestinal disorders
Periodontal disease
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Nervous system disorders
Trigeminal nerve disorder
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Infections and infestations
Infection
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Lethargy
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Pain in extremity
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Infections and infestations
Wound infection
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Gastrointestinal disorders
Pharyngitis
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Nervous system disorders
Encephalopathy
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Nervous system disorders
Dyskinesia
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Cardiac disorders
Supraventricular tachycardia
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Investigations
Blood alkaline phosphatase increased
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Asthenia
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Infections and infestations
Alpha haemolytic streptococcal infection
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Infections and infestations
Corynebacterium infection
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Gastrointestinal disorders
Lip disorder
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Investigations
Hypoalbuminaemia
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Nervous system disorders
Intracranial pressure increased
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Allergic transfusion reaction
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
General disorders
Leukaemic infiltration
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
4.5%
1/22 • From signature of informed consent till up to 30 days after last study drug administration, or longer, as necessary.
Treatment-related Adverse Events
|
Additional Information
Dr. Sumeet Ambarkhane, Director, Clinical Program Leader
MorphoSys AG
Phone: 004989899270
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee As specified in the respective clinical trial agreements with the PI.
- Publication restrictions are in place
Restriction type: OTHER