COSMOS: Study to Evaluate Safety and Preliminary Efficacy of Tafasitamab With Idelalisib or Venetoclax in R/R CLL/SLL Patients Pretreated With BTKi
Study Details
Study Description
Brief Summary
This is a two-cohort, multicenter, open-label study of tafasitamab (MOR208) combined with idelalisib or venetoclax in adult patients with R/R CLL or R/R SLL pretreated with a BTK inhibitor (e.g., ibrutinib) as single agent or as part of combination therapy. Patients completing the study treatment are invited to participate in an optional biomarker sub-study.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
The purpose of this study is to evaluate the clinical safety and preliminary efficacy of tafasitamab (MOR208) combined with idelalisib or venetoclax. The study will include safety run-in phase for each cohort with an evaluation of the safety data by an Independent Data Monitoring Committee.
An optional sub-study has been introduced to collect biological samples for investigations on biomarkers (e.g., CD19 expression) after tafasitamab treatment.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cohort A tafasitamab (MOR208) in combination with idelalisib |
Biological: Tafasitamab
tafasitamab (MOR208) dose: 12 mg/kg intravenous infusion
Other Names:
Drug: Idelalisib
idelalisib dose: 150 mg twice daily orally
Other Names:
|
Experimental: Cohort B tafasitamab (MOR208) in combination with venetoclax |
Biological: Tafasitamab
tafasitamab (MOR208) dose: 12 mg/kg intravenous infusion
Other Names:
Drug: Venetoclax
venetoclax dose: 400 mg once daily orally
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence and Severity of Adverse Events (AEs) [2 years]
For details please see Section of Adverse Events Overview
Secondary Outcome Measures
- Best Objective Response Rate (ORR) [2 years]
ORR = complete response [CR] + partial response [PR]; Local Evaluation
- Number of Participants With Treatment-emergent or Treatment-boosted Anti-MOR00208 Antibody Formation [2 years]
Number of participants with treatment-emergent or treatment-boosted anti-MOR00208 (anti-tafasitamab) antibody formation
- Maximum Plasma Concentration (Cmax) of MOR00208 [At Cycle 3 Day 15]
Mean Cmax of tafasitamab (MOR00208) at Cycle 3 Day 15 (after the weekly dosing of tafasitamab in Cycles 1 to 3 including a loading dose at C1D4)
Other Outcome Measures
- Proportion of Patients With MRD-negativity [2 years]
Proportion of patients who reached MRD-negativity in peripheral blood
Eligibility Criteria
Criteria
Major inclusion criteria
Diagnosis/Trial Population
-
Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL):
-
history of diagnosis of CLL or SLL that meets IWCLL diagnostic criteria
-
histologically confirmed diagnosis of SLL by lymph node biopsy
-
indication for treatment as defined by the IWCLL guidelines
-
Patients must have both of the following:
-
relapsed or refractory disease while receiving a BTKi therapy or intolerance of such therapy
-
single-agent or combination therapy with a BTKi for at least one month must be the patient's most recent prior anticancer therapy
-
ECOG performance status of 0 to 2
-
Patients with a past medical history of autologous or allogeneic stem cell transplantation must exhibit full hematological recovery
Laboratory Values
• Patients must meet adequate bone marrow function and adequate hepatic and renal function
Other Inclusion Criteria
• Females of childbearing potential must use a highly effective method of contraception
Major exclusion criteria
Diagnosis
• Patients who have:
-
non-Hodgkin's lymphomas other than CLL/SLL
-
transformed CLL/SLL or Richter's syndrome
-
active and uncontrolled autoimmune cytopenia
Previous and Current Treatment
-
Patients who have received treatment with a BTK inhibitor within 5 days prior to Day 1 dosing
-
Patients who have, within 14 days prior to D1 dosing:
-
not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy
-
systemic corticosteroids in doses greater than prednisone equivalent to 20 mg/day with the exception of patients with signs of rapidly progressing disease
-
received live vaccines with the exception of vaccination against influenza with inactivated virus or for pneumococcal diseases
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Clinical Study Site | Jacksonville | Florida | United States | 32204 |
2 | Clinical Study Site | Rochester | Minnesota | United States | 55905 |
3 | Clinical Study Site | Columbus | Ohio | United States | 43210 |
4 | Clinical Study Site | Graz | Austria | 8036 | |
5 | Clinical Study Site | Salzburg | Austria | 5020 | |
6 | Clinical Study Site | Wien | Austria | 1090 | |
7 | Clinical Study Site | Dresden | Germany | 1307 | |
8 | Clinical Study Site | Leipzig | Germany | 4103 | |
9 | Clinical Study Site | Muenchen | Germany | 80804 | |
10 | Clinical Study Site | Brescia | Italy | 25123 | |
11 | Clinical Study Site | Milano | Italy | 20162 | |
12 | Clinical Study Site | Gdansk | Poland | 80952 | |
13 | Clinical Study Site | Krakow | Poland | 30510 | |
14 | Clinical Study Site | Lublin | Poland | 85094 | |
15 | Clinical Study Site | Opole | Poland | 45372 | |
16 | Clinical Study Site | Bournemouth | United Kingdom | BH7 7DW | |
17 | Clinical Study Site | Leeds | United Kingdom | LS9 7TF |
Sponsors and Collaborators
- MorphoSys AG
Investigators
- Study Director: Anke Muth, Clinical Development, MorphoSys AG
Study Documents (Full-Text)
More Information
Publications
None provided.- MOR208C205
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) |
---|---|---|
Arm/Group Description | Tafasitamab (MOR208) in combination with idelalisib Tafasitamab dose: 12 mg/kg intravenous infusion Idelalisib dose: 150 mg twice daily orally | Tafasitamab (MOR208) in combination with venetoclax Tafasitamab dose: 12 mg/kg intravenous infusion Venetoclax dose: 400 mg once daily orally |
Period Title: Overall Study | ||
STARTED | 11 | 13 |
COMPLETED | 7 | 5 |
NOT COMPLETED | 4 | 8 |
Baseline Characteristics
Arm/Group Title | Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) | Total |
---|---|---|---|
Arm/Group Description | Tafasitamab in combination with idelalisib | Tafasitamab in combination with venetoclax | Total of all reporting groups |
Overall Participants | 11 | 13 | 24 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
3
27.3%
|
8
61.5%
|
11
45.8%
|
>=65 years |
8
72.7%
|
5
38.5%
|
13
54.2%
|
Age (years) [Median (Full Range) ] | |||
Median (Full Range) [years] |
69
|
64
|
65
|
Sex: Female, Male (Count of Participants) | |||
Female |
5
45.5%
|
3
23.1%
|
8
33.3%
|
Male |
6
54.5%
|
10
76.9%
|
16
66.7%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
0
0%
|
0
0%
|
0
0%
|
White |
11
100%
|
13
100%
|
24
100%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (participants) [Number] | |||
Austria |
2
18.2%
|
4
30.8%
|
6
25%
|
United States |
0
0%
|
6
46.2%
|
6
25%
|
Poland |
5
45.5%
|
0
0%
|
5
20.8%
|
Italy |
1
9.1%
|
0
0%
|
1
4.2%
|
United Kingdom |
0
0%
|
2
15.4%
|
2
8.3%
|
Germany |
3
27.3%
|
1
7.7%
|
4
16.7%
|
Number of previous systemic treatment lines (Lines) [Median (Full Range) ] | |||
Median (Full Range) [Lines] |
5
|
3
|
4
|
Outcome Measures
Title | Incidence and Severity of Adverse Events (AEs) |
---|---|
Description | For details please see Section of Adverse Events Overview |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) |
---|---|---|
Arm/Group Description | Tafasitamab in combination with idelalisib | Tafasitamab in combination with venetoclax |
Measure Participants | 11 | 13 |
Count of Participants [Participants] |
11
100%
|
13
100%
|
Title | Best Objective Response Rate (ORR) |
---|---|
Description | ORR = complete response [CR] + partial response [PR]; Local Evaluation |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
Intention-to-treat patient population consists of all enrolled patients. As per study protocol all patients were required to have computed tomography (CT) scans of the neck, chest, abdomen and pelvis to determine tumor response. These were performed at screening, at Day 1 of Cycles 4, 7, 13, and 19, etc. and at end-of-treatment. |
Arm/Group Title | Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) |
---|---|---|
Arm/Group Description | Tafasitamab in combination with idelalisib | Tafasitamab in combination with venetoclax |
Measure Participants | 11 | 13 |
Intention-to-treat patient population |
90.9
826.4%
|
76.9
591.5%
|
Pts with tumor response assessment by CT |
90.9
826.4%
|
100
769.2%
|
Title | Number of Participants With Treatment-emergent or Treatment-boosted Anti-MOR00208 Antibody Formation |
---|---|
Description | Number of participants with treatment-emergent or treatment-boosted anti-MOR00208 (anti-tafasitamab) antibody formation |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) |
---|---|---|
Arm/Group Description | Tafasitamab in combination with idelalisib | Tafasitamab in combination with venetoclax |
Measure Participants | 11 | 13 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
Title | Maximum Plasma Concentration (Cmax) of MOR00208 |
---|---|
Description | Mean Cmax of tafasitamab (MOR00208) at Cycle 3 Day 15 (after the weekly dosing of tafasitamab in Cycles 1 to 3 including a loading dose at C1D4) |
Time Frame | At Cycle 3 Day 15 |
Outcome Measure Data
Analysis Population Description |
---|
All patients with available pharmacokinetic data for Cmax at Cycle 3 Day 15. |
Arm/Group Title | Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) |
---|---|---|
Arm/Group Description | Tafasitamab in combination with idelalisib | Tafasitamab in combination with venetoclax |
Measure Participants | 7 | 9 |
Mean (Standard Deviation) [ng/mL] |
278379.9
(118746.34)
|
306998.9
(41254.20)
|
Title | Proportion of Patients With MRD-negativity |
---|---|
Description | Proportion of patients who reached MRD-negativity in peripheral blood |
Time Frame | 2 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) |
---|---|---|
Arm/Group Description | Tafasitamab in combination with idelalisib | Tafasitamab in combination with venetoclax |
Measure Participants | 11 | 13 |
Count of Participants [Participants] |
1
9.1%
|
6
46.2%
|
Adverse Events
Time Frame | From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first. | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) | ||
Arm/Group Description | Tafasitamab in combination with idelalisib | Tafasitamab in combination with venetoclax | ||
All Cause Mortality |
||||
Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/11 (18.2%) | 0/13 (0%) | ||
Serious Adverse Events |
||||
Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 8/11 (72.7%) | 9/13 (69.2%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 1/11 (9.1%) | 1 | 1/13 (7.7%) | 1 |
Pancytopenia | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Thrombocytopenia | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Cardiac disorders | ||||
Cardiac failure | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Gastrointestinal disorders | ||||
Diarrhoea | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Pancreatitis acute | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
General disorders | ||||
Pyrexia | 0/11 (0%) | 0 | 3/13 (23.1%) | 4 |
Infections and infestations | ||||
Pneumonia | 2/11 (18.2%) | 2 | 1/13 (7.7%) | 1 |
Bronchitis | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Gastroenteritis salmonella | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Influenza | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Pulmonary sepsis | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Rhinovirus infection | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Septic shock | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Upper respiratory tract infection | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Injury, poisoning and procedural complications | ||||
Infusion related reaction | 0/11 (0%) | 0 | 2/13 (15.4%) | 2 |
Investigations | ||||
C-reactive protein increased | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Metabolism and nutrition disorders | ||||
Tumour lysis syndrome | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Musculoskeletal and connective tissue disorders | ||||
Arthralgia | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Bone pain | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Groin pain | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 11/11 (100%) | 12/13 (92.3%) | ||
Blood and lymphatic system disorders | ||||
Neutropenia | 5/11 (45.5%) | 15 | 6/13 (46.2%) | 21 |
Anaemia | 5/11 (45.5%) | 6 | 2/13 (15.4%) | 4 |
Thrombocytopenia | 3/11 (27.3%) | 3 | 1/13 (7.7%) | 1 |
Lymphopenia | 1/11 (9.1%) | 1 | 1/13 (7.7%) | 1 |
Anaemia of malignant disease | 1/11 (9.1%) | 2 | 0/13 (0%) | 0 |
Leukocytosis | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Leukopenia | 0/11 (0%) | 0 | 3/13 (23.1%) | 4 |
Lymphadenopathy | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Splenic infarction | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Cardiac disorders | ||||
Arrhythmia | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Atrial fibrillation | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Cardiovascular insufficiency | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Myocardial ischaemia | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Tachyarrhythmia | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Tachycardia | 0/11 (0%) | 0 | 2/13 (15.4%) | 2 |
Atrioventricular block | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Atrioventricular block second degree | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Palpitations | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Ear and labyrinth disorders | ||||
Vertigo | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Deafness unilateral | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Ear discomfort | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Eye disorders | ||||
Erythema of eyelid | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Holmes-Adie pupil | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Pupils unequal | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Visual impairment | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Gastrointestinal disorders | ||||
Nausea | 1/11 (9.1%) | 1 | 5/13 (38.5%) | 6 |
Diarrhoea | 3/11 (27.3%) | 5 | 2/13 (15.4%) | 2 |
Dysphagia | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Erosive duodenitis | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Flatulence | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Gastritis erosive | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Gastrooesophageal reflux disease | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Glossitis | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Noninfective sialoadenitis | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Dyspepsia | 0/11 (0%) | 0 | 3/13 (23.1%) | 3 |
Vomiting | 0/11 (0%) | 0 | 3/13 (23.1%) | 3 |
Abdominal distension | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Abdominal pain | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Anal haemorrhage | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Constipation | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Dry mouth | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Haematochezia | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Inguinal hernia | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Oral pain | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Umbilical hernia | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
General disorders | ||||
Pyrexia | 5/11 (45.5%) | 8 | 2/13 (15.4%) | 2 |
Fatigue | 1/11 (9.1%) | 2 | 3/13 (23.1%) | 3 |
General physical health deterioration | 2/11 (18.2%) | 2 | 0/13 (0%) | 0 |
Oedema peripheral | 1/11 (9.1%) | 1 | 1/13 (7.7%) | 1 |
Asthenia | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Catheter site haematoma | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Feeling hot | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Gait disturbance | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Mucosal inflammation | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Catheter site inflammation | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Chest discomfort | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Chills | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Drug intolerance | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Face oedema | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Malaise | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Hepatobiliary disorders | ||||
Cholelithiasis | 2/11 (18.2%) | 3 | 1/13 (7.7%) | 1 |
Hydrocholecystis | 2/11 (18.2%) | 2 | 0/13 (0%) | 0 |
Hepatotoxicity | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Hepatic cyst | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Hyperbilirubinaemia | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Immune system disorders | ||||
Immunodeficiency | 2/11 (18.2%) | 2 | 1/13 (7.7%) | 1 |
Contrast media allergy | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Drug hypersensitivity | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Graft versus host disease in liver | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Hypersensitivity | 0/11 (0%) | 0 | 1/13 (7.7%) | 2 |
Infections and infestations | ||||
Urinary tract infection | 3/11 (27.3%) | 4 | 1/13 (7.7%) | 1 |
Pneumonia | 1/11 (9.1%) | 1 | 2/13 (15.4%) | 2 |
Respiratory tract infection | 1/11 (9.1%) | 1 | 2/13 (15.4%) | 2 |
Upper respiratory tract infection | 1/11 (9.1%) | 1 | 2/13 (15.4%) | 2 |
Cytomegalovirus infection | 2/11 (18.2%) | 2 | 0/13 (0%) | 0 |
Nasopharyngitis | 1/11 (9.1%) | 1 | 1/13 (7.7%) | 1 |
Aspergillus infection | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Bronchitis | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Fungal oesophagitis | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Gastrointestinal candidiasis | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Gastrointestinal infection | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Helicobacter infection | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Infection | 1/11 (9.1%) | 2 | 0/13 (0%) | 0 |
Pharyngitis | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Erysipelas | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Helicobacter gastritis | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Infectious pleural effusion | 0/11 (0%) | 0 | 1/13 (7.7%) | 2 |
Lung infection | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Paronychia | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Pneumococcal sepsis | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Rhinitis | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Sinusitis | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Staphylococcal infection | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Injury, poisoning and procedural complications | ||||
Infusion related reaction | 5/11 (45.5%) | 5 | 5/13 (38.5%) | 7 |
Fall | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Medication error | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Overdose | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Arthropod bite | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Tendon rupture | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Investigations | ||||
Alanine aminotransferase increased | 3/11 (27.3%) | 3 | 1/13 (7.7%) | 1 |
Weight decreased | 1/11 (9.1%) | 1 | 2/13 (15.4%) | 3 |
Amylase increased | 2/11 (18.2%) | 3 | 0/13 (0%) | 0 |
Aspartate aminotransferase increased | 1/11 (9.1%) | 1 | 1/13 (7.7%) | 1 |
C-reactive protein increased | 1/11 (9.1%) | 2 | 1/13 (7.7%) | 1 |
Body temperature increased | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Coagulation time prolonged | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Lipase increased | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Transaminases increased | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Blood lactate dehydrogenase increased | 0/11 (0%) | 0 | 4/13 (30.8%) | 4 |
Troponin T increased | 0/11 (0%) | 0 | 3/13 (23.1%) | 3 |
Brain natriuretic peptide increased | 0/11 (0%) | 0 | 2/13 (15.4%) | 2 |
Coombs test positive | 0/11 (0%) | 0 | 2/13 (15.4%) | 2 |
Blood alkaline phosphatase increased | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Electrocardiogram T wave abnormal | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Gamma-glutamyltransferase increased | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Hepatic enzyme increased | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Weight increased | 0/11 (0%) | 0 | 1/13 (7.7%) | 2 |
Metabolism and nutrition disorders | ||||
Hypocalcaemia | 2/11 (18.2%) | 2 | 3/13 (23.1%) | 3 |
Hypokalaemia | 1/11 (9.1%) | 1 | 3/13 (23.1%) | 4 |
Hyperkalaemia | 2/11 (18.2%) | 2 | 1/13 (7.7%) | 1 |
Hypoalbuminaemia | 2/11 (18.2%) | 2 | 1/13 (7.7%) | 1 |
Hypomagnesaemia | 1/11 (9.1%) | 1 | 1/13 (7.7%) | 1 |
Dehydration | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Hypercholesterolaemia | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Hypoproteinaemia | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Type 2 diabetes mellitus | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Hyperuricaemia | 0/11 (0%) | 0 | 5/13 (38.5%) | 6 |
Hypophosphataemia | 0/11 (0%) | 0 | 4/13 (30.8%) | 4 |
Iron deficiency | 0/11 (0%) | 0 | 3/13 (23.1%) | 3 |
Hyperglycaemia | 0/11 (0%) | 0 | 2/13 (15.4%) | 2 |
Decreased appetite | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Hypercalcaemia | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Hypermagnesaemia | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Musculoskeletal and connective tissue disorders | ||||
Pain in extremity | 1/11 (9.1%) | 1 | 1/13 (7.7%) | 1 |
Bone pain | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Arthralgia | 0/11 (0%) | 0 | 2/13 (15.4%) | 3 |
Muscle spasms | 0/11 (0%) | 0 | 2/13 (15.4%) | 2 |
Myalgia | 0/11 (0%) | 0 | 2/13 (15.4%) | 2 |
Exostosis | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Joint swelling | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Musculoskeletal pain | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Osteosclerosis | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Lung neoplasm | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Nervous system disorders | ||||
Dizziness | 1/11 (9.1%) | 3 | 2/13 (15.4%) | 4 |
Headache | 2/11 (18.2%) | 2 | 1/13 (7.7%) | 1 |
Burning sensation | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Hypoaesthesia | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Lethargy | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Neuropathy peripheral | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Psychiatric disorders | ||||
Insomnia | 1/11 (9.1%) | 1 | 2/13 (15.4%) | 2 |
Sleep disorder | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Agitation | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Depressed mood | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Depression | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Renal and urinary disorders | ||||
Acute kidney injury | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Renal failure | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Renal impairment | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Haematuria | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||||
Cough | 3/11 (27.3%) | 4 | 5/13 (38.5%) | 5 |
Dyspnoea | 5/11 (45.5%) | 5 | 3/13 (23.1%) | 3 |
Pleural effusion | 2/11 (18.2%) | 2 | 1/13 (7.7%) | 1 |
Dyspnoea exertional | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Pulmonary oedema | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Rales | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Tachypnoea | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Upper respiratory tract inflammation | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Atelectasis | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Haemothorax | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Increased bronchial secretion | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Pneumothorax | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Pulmonary embolism | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Rhinitis allergic | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Sinus disorder | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Small airways disease | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Skin and subcutaneous tissue disorders | ||||
Rash | 2/11 (18.2%) | 2 | 1/13 (7.7%) | 1 |
Dry skin | 1/11 (9.1%) | 1 | 1/13 (7.7%) | 1 |
Hyperhidrosis | 1/11 (9.1%) | 1 | 1/13 (7.7%) | 2 |
Skin lesion | 1/11 (9.1%) | 1 | 1/13 (7.7%) | 1 |
Eczema | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Alopecia | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Onychoclasis | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Pruritus | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Skin haemorrhage | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Vascular disorders | ||||
Hypertension | 2/11 (18.2%) | 2 | 1/13 (7.7%) | 1 |
Aortic dilatation | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Circulatory collapse | 1/11 (9.1%) | 1 | 0/13 (0%) | 0 |
Deep vein thrombosis | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Flushing | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Hypotension | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Orthostatic hypotension | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Peripheral venous disease | 0/11 (0%) | 0 | 1/13 (7.7%) | 1 |
Limitations/Caveats
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.
Results Point of Contact
Name/Title | Peter Kelemen MD, PhD - Director, Clinical Program Leader |
---|---|
Organization | MorphoSys AG |
Phone | +498989927 ext 26856 |
peter.kelemen@morphosys.com |
- MOR208C205