Trial Outcomes & Findings for New Combination of Chemoimmunotherapy for Systemic B-cell Lymphoma With Central Nervous System Involvement (NCT NCT02329080)
NCT ID: NCT02329080
Last Updated: 2025-07-08
Results Overview
Percentage of patients free from progression after 1 year from study entry
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
From study entry until 1 year after
Results posted on
2025-07-08
Participant Flow
During the recruitment period 79 patients were enrolled and 75 of them were treated. Four patients were excluded after enrolment before the start of study treatment because of unrelated laboratory abnormalities (two patients), disease only at flow cytometry examination of the cerebrospinal fluid (one), and death at the same time as registration (one).
Participant milestones
| Measure |
MATRIX - R-ICE - Conditioning and ASCT
MATRIX (courses 1,2,3): Rituximab 375 mg/m2 d0/Methotrexate 3.5 g/m2 d1/Cytarabine 2 g/m2 d2 \& d3/Thiotepa 30 mg/m2 d4/Liposomial Cytarabine 50 mg\* d5
R-ICE (courses 4,5,6):Rituximab 375 mg/m2 d1/Etoposide 100 mg/m2 d1,d2, d3/Ifosfamide 5 g/m2 d2/Carboplatin 5 AUC d2/Liposomial Cytarabine 50 mg\* d4
\*If liposomal cytarabine is not available, standard intrathecal chemotherapy with methotrexate 10 mg + cytarabine 40 mg + hydrocortisone 50 mg can be administered. Oral steroids are suggested for 2-3 days after intrathecal liposomial cytarabine delivery to prevent chemical or aseptic meningitis/ arachnoiditis.
Conditioning and ASCT: BCNU (carmustine)\*\* 400 mg/m2 d-6/Thiotepa 5 mg/kg d-5 \& d-4 ASCT: 5 x 106 CD34+cells/kg d0
\*\*In case of BCNU unavailability, the recommended conditioning regimen (Phase IV) is: Thiotepa 5 mg/kg d-6 \& d-5/Busulfan 3.2 mg/kg d-4,d -3,d-2/Clonazepam 2 mg/d d-4,d -3,d-2 ASCT: 5 x 106 CD34+cells/kg d0
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
38
|
Reasons for withdrawal
| Measure |
MATRIX - R-ICE - Conditioning and ASCT
MATRIX (courses 1,2,3): Rituximab 375 mg/m2 d0/Methotrexate 3.5 g/m2 d1/Cytarabine 2 g/m2 d2 \& d3/Thiotepa 30 mg/m2 d4/Liposomial Cytarabine 50 mg\* d5
R-ICE (courses 4,5,6):Rituximab 375 mg/m2 d1/Etoposide 100 mg/m2 d1,d2, d3/Ifosfamide 5 g/m2 d2/Carboplatin 5 AUC d2/Liposomial Cytarabine 50 mg\* d4
\*If liposomal cytarabine is not available, standard intrathecal chemotherapy with methotrexate 10 mg + cytarabine 40 mg + hydrocortisone 50 mg can be administered. Oral steroids are suggested for 2-3 days after intrathecal liposomial cytarabine delivery to prevent chemical or aseptic meningitis/ arachnoiditis.
Conditioning and ASCT: BCNU (carmustine)\*\* 400 mg/m2 d-6/Thiotepa 5 mg/kg d-5 \& d-4 ASCT: 5 x 106 CD34+cells/kg d0
\*\*In case of BCNU unavailability, the recommended conditioning regimen (Phase IV) is: Thiotepa 5 mg/kg d-6 \& d-5/Busulfan 3.2 mg/kg d-4,d -3,d-2/Clonazepam 2 mg/d d-4,d -3,d-2 ASCT: 5 x 106 CD34+cells/kg d0
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
4
|
|
Overall Study
Lack of Efficacy
|
22
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Partial response
|
4
|
|
Overall Study
Complete response
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MATRIX - R-ICE - Conditioning and ASCT
n=75 Participants
MATRIX (courses 1,2,3): Rituximab 375 mg/m2 d0/Methotrexate 3.5 g/m2 d1/Cytarabine 2 g/m2 d2 \& d3/Thiotepa 30 mg/m2 d4/Liposomial Cytarabine 50 mg\* d5
R-ICE (courses 4,5,6):Rituximab 375 mg/m2 d1/Etoposide 100 mg/m2 d1,d2, d3/Ifosfamide 5 g/m2 d2/Carboplatin 5 AUC d2/Liposomial Cytarabine 50 mg\* d4
\*If liposomal cytarabine is not available, standard intrathecal chemotherapy with methotrexate 10 mg + cytarabine 40 mg + hydrocortisone 50 mg can be administered. Oral steroids are suggested for 2-3 days after intrathecal liposomial cytarabine delivery to prevent chemical or aseptic meningitis/ arachnoiditis.
Conditioning and ASCT: BCNU (carmustine)\*\* 400 mg/m2 d-6/Thiotepa 5 mg/kg d-5 \& d-4 ASCT: 5 x 106 CD34+cells/kg d0
\*\*In case of BCNU unavailability, the recommended conditioning regimen (Phase IV) is: Thiotepa 5 mg/kg d-6 \& d-5/Busulfan 3.2 mg/kg d-4,d -3,d-2/Clonazepam 2 mg/d d-4,d -3,d-2 ASCT: 5 x 106 CD34+cells/kg d0
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=75 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=75 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=75 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=75 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=75 Participants
|
|
Region of Enrollment
Netherlands
|
4 participants
n=75 Participants
|
|
Region of Enrollment
Italy
|
52 participants
n=75 Participants
|
|
Region of Enrollment
United Kingdom
|
18 participants
n=75 Participants
|
|
Region of Enrollment
Switzerland
|
1 participants
n=75 Participants
|
|
CNS involvement at presentation
CNS involvement at presentation
|
32 Participants
n=75 Participants
|
|
CNS involvement at presentation
No CNS involvement at presentation
|
43 Participants
n=75 Participants
|
|
Isolated CNS relapse
Isolated CNS relapse
|
15 Participants
n=75 Participants
|
|
Isolated CNS relapse
No isolated CNS relapse
|
60 Participants
n=75 Participants
|
|
Concomitant CNS-systemic localisation
Concomitant CNS-systemic localisation
|
28 Participants
n=75 Participants
|
|
Concomitant CNS-systemic localisation
No concomitant CNS-systemic localisation
|
47 Participants
n=75 Participants
|
|
HBV or HCV seropositivity
HBV or HCV seropositivity
|
2 Participants
n=75 Participants
|
|
HBV or HCV seropositivity
No HBV or HCV seropositivity
|
73 Participants
n=75 Participants
|
|
CNS site of disease - Brain parenchima
Brain parenchima
|
34 Participants
n=75 Participants
|
|
CNS site of disease - Brain parenchima
No brain parenchima
|
41 Participants
n=75 Participants
|
|
CNS site of disease - Cerebrospinal fluid or meninges
Cerebrospinal fluid or meninges
|
8 Participants
n=75 Participants
|
|
CNS site of disease - Cerebrospinal fluid or meninges
No cerebrospinal fluid or meninges
|
67 Participants
n=75 Participants
|
|
CNS sites of disease - Spinal cord
Spinal cord
|
2 Participants
n=75 Participants
|
|
CNS sites of disease - Spinal cord
No spinal cord
|
73 Participants
n=75 Participants
|
|
CNS sites of disease - Eyes
Eyes
|
2 Participants
n=75 Participants
|
|
CNS sites of disease - Eyes
No eyes
|
73 Participants
n=75 Participants
|
|
CNS sites of disease - Brain and cerebrospinal fluid or meninges
Brain and cerebrospinal fluid or meninges
|
13 Participants
n=75 Participants
|
|
CNS sites of disease - Brain and cerebrospinal fluid or meninges
No brain and cerebrospinal fluid or meninges
|
62 Participants
n=75 Participants
|
|
CNS sites of disease - Brain and eyes
Brain and eyes
|
10 Participants
n=75 Participants
|
|
CNS sites of disease - Brain and eyes
No Brain and eyes
|
65 Participants
n=75 Participants
|
|
CNS sites of disease - Brain, cerebrospinal fluid and eyes
Brain, cerebrospinal fluid and eyes
|
6 Participants
n=75 Participants
|
|
CNS sites of disease - Brain, cerebrospinal fluid and eyes
No brain, cerebrospinal fluid and eyes
|
69 Participants
n=75 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
ECOG-PS > 1
|
28 Participants
n=75 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
ECOG-PS </= 1
|
47 Participants
n=75 Participants
|
|
Number of extranodal organs involved (other than CNS)
Number of extranodal organs involved >1
|
23 Participants
n=75 Participants
|
|
Number of extranodal organs involved (other than CNS)
Number of extranodal organs involved </=1
|
52 Participants
n=75 Participants
|
|
High LDH serum concentration
High LDH serum concentration
|
37 Participants
n=75 Participants
|
|
High LDH serum concentration
No high LDH serum concentration
|
38 Participants
n=75 Participants
|
|
Advanced stage
Advanced stage
|
60 Participants
n=75 Participants
|
|
Advanced stage
No advanced stage
|
15 Participants
n=75 Participants
|
|
International Prognostic Index (IPI)
Low IPI risk
|
14 Participants
n=75 Participants
|
|
International Prognostic Index (IPI)
Low-intermediate IPI risk
|
18 Participants
n=75 Participants
|
|
International Prognostic Index (IPI)
High-intermediate IPI risk
|
26 Participants
n=75 Participants
|
|
International Prognostic Index (IPI)
High IPI risk
|
17 Participants
n=75 Participants
|
PRIMARY outcome
Timeframe: From study entry until 1 year afterPercentage of patients free from progression after 1 year from study entry
Outcome measures
| Measure |
MATRIX - R-ICE - Conditioning and ASCT
n=75 Participants
MATRIX (courses 1,2,3): Rituximab 375 mg/m2 d0/Methotrexate 3.5 g/m2 d1/Cytarabine 2 g/m2 d2 \& d3/Thiotepa 30 mg/m2 d4/Liposomial Cytarabine 50 mg\* d5
R-ICE (courses 4,5,6):Rituximab 375 mg/m2 d1/Etoposide 100 mg/m2 d1,d2, d3/Ifosfamide 5 g/m2 d2/Carboplatin 5 AUC d2/Liposomial Cytarabine 50 mg\* d4
\*If liposomal cytarabine is not available, standard intrathecal chemotherapy with methotrexate 10 mg + cytarabine 40 mg + hydrocortisone 50 mg can be administered. Oral steroids are suggested for 2-3 days after intrathecal liposomial cytarabine delivery to prevent chemical or aseptic meningitis/ arachnoiditis.
Conditioning and ASCT: BCNU (carmustine)\*\* 400 mg/m2 d-6/Thiotepa 5 mg/kg d-5 \& d-4 ASCT: 5 x 106 CD34+cells/kg d0
\*\*In case of BCNU unavailability, the recommended conditioning regimen (Phase IV) is: Thiotepa 5 mg/kg d-6 \& d-5/Busulfan 3.2 mg/kg d-4,d -3,d-2/Clonazepam 2 mg/d d-4,d -3,d-2 ASCT: 5 x 106 CD34+cells/kg d0
|
|---|---|
|
1 Year Progression Free Survival (PFS)
|
58 Percentage of participants
Interval 55.0 to 61.0
|
SECONDARY outcome
Timeframe: From study entry until 2 years afterPercentage of patients free from progression after 2 years from study entry
Outcome measures
| Measure |
MATRIX - R-ICE - Conditioning and ASCT
n=75 Participants
MATRIX (courses 1,2,3): Rituximab 375 mg/m2 d0/Methotrexate 3.5 g/m2 d1/Cytarabine 2 g/m2 d2 \& d3/Thiotepa 30 mg/m2 d4/Liposomial Cytarabine 50 mg\* d5
R-ICE (courses 4,5,6):Rituximab 375 mg/m2 d1/Etoposide 100 mg/m2 d1,d2, d3/Ifosfamide 5 g/m2 d2/Carboplatin 5 AUC d2/Liposomial Cytarabine 50 mg\* d4
\*If liposomal cytarabine is not available, standard intrathecal chemotherapy with methotrexate 10 mg + cytarabine 40 mg + hydrocortisone 50 mg can be administered. Oral steroids are suggested for 2-3 days after intrathecal liposomial cytarabine delivery to prevent chemical or aseptic meningitis/ arachnoiditis.
Conditioning and ASCT: BCNU (carmustine)\*\* 400 mg/m2 d-6/Thiotepa 5 mg/kg d-5 \& d-4 ASCT: 5 x 106 CD34+cells/kg d0
\*\*In case of BCNU unavailability, the recommended conditioning regimen (Phase IV) is: Thiotepa 5 mg/kg d-6 \& d-5/Busulfan 3.2 mg/kg d-4,d -3,d-2/Clonazepam 2 mg/d d-4,d -3,d-2 ASCT: 5 x 106 CD34+cells/kg d0
|
|---|---|
|
2 Years Progression Free Survival (PFS)
|
46 percentage of participants
Interval 39.0 to 53.0
|
SECONDARY outcome
Timeframe: From trial entry until 2 years afterPercentage of participants alive after 2 years from study entry
Outcome measures
| Measure |
MATRIX - R-ICE - Conditioning and ASCT
n=75 Participants
MATRIX (courses 1,2,3): Rituximab 375 mg/m2 d0/Methotrexate 3.5 g/m2 d1/Cytarabine 2 g/m2 d2 \& d3/Thiotepa 30 mg/m2 d4/Liposomial Cytarabine 50 mg\* d5
R-ICE (courses 4,5,6):Rituximab 375 mg/m2 d1/Etoposide 100 mg/m2 d1,d2, d3/Ifosfamide 5 g/m2 d2/Carboplatin 5 AUC d2/Liposomial Cytarabine 50 mg\* d4
\*If liposomal cytarabine is not available, standard intrathecal chemotherapy with methotrexate 10 mg + cytarabine 40 mg + hydrocortisone 50 mg can be administered. Oral steroids are suggested for 2-3 days after intrathecal liposomial cytarabine delivery to prevent chemical or aseptic meningitis/ arachnoiditis.
Conditioning and ASCT: BCNU (carmustine)\*\* 400 mg/m2 d-6/Thiotepa 5 mg/kg d-5 \& d-4 ASCT: 5 x 106 CD34+cells/kg d0
\*\*In case of BCNU unavailability, the recommended conditioning regimen (Phase IV) is: Thiotepa 5 mg/kg d-6 \& d-5/Busulfan 3.2 mg/kg d-4,d -3,d-2/Clonazepam 2 mg/d d-4,d -3,d-2 ASCT: 5 x 106 CD34+cells/kg d0
|
|---|---|
|
2 Years Overall Survival (OS)
|
46 percentage of participants
Interval 39.0 to 53.0
|
Adverse Events
MATRIX - R-ICE - Conditioning and ASCT
Serious events: 46 serious events
Other events: 72 other events
Deaths: 50 deaths
Enrolled, But Not Treated
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MATRIX - R-ICE - Conditioning and ASCT
n=75 participants at risk
MATRIX (courses 1,2,3): Rituximab 375 mg/m2 d0/Methotrexate 3.5 g/m2 d1/Cytarabine 2 g/m2 d2 \& d3/Thiotepa 30 mg/m2 d4/Liposomial Cytarabine 50 mg\* d5
R-ICE (courses 4,5,6):Rituximab 375 mg/m2 d1/Etoposide 100 mg/m2 d1,d2, d3/Ifosfamide 5 g/m2 d2/Carboplatin 5 AUC d2/Liposomial Cytarabine 50 mg\* d4
\*If liposomal cytarabine is not available, standard intrathecal chemotherapy with methotrexate 10 mg + cytarabine 40 mg + hydrocortisone 50 mg can be administered. Oral steroids are suggested for 2-3 days after intrathecal liposomial cytarabine delivery to prevent chemical or aseptic meningitis/ arachnoiditis.
Conditioning and ASCT: BCNU (carmustine)\*\* 400 mg/m2 d-6/Thiotepa 5 mg/kg d-5 \& d-4 ASCT: 5 x 106 CD34+cells/kg d0
\*\*In case of BCNU unavailability, the recommended conditioning regimen (Phase IV) is: Thiotepa 5 mg/kg d-6 \& d-5/Busulfan 3.2 mg/kg d-4,d -3,d-2/Clonazepam 2 mg/d d-4,d -3,d-2 ASCT: 5 x 106 CD34+cells/kg d0
|
Enrolled, But Not Treated
n=4 participants at risk
Four patients were excluded after enrolment
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Investigations
Hyponatremia
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Poorly differentiated adenocarcinoma
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Vascular disorders
Bleeding
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Vascular disorders
Thromboembolic event
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Vascular disorders
Deep vein thrombosis
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Nervous system disorders
Neurological toxicity
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Nervous system disorders
Brain ischemic stroke
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Nervous system disorders
Encephalopathy
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Nervous system disorders
Bleeding brain lesion
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
General disorders
Fatigue
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
General disorders
Fever
|
1.3%
1/75 • Number of events 2 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
General disorders
Pain
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
21.3%
16/75 • Number of events 23 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Blood and lymphatic system disorders
Neutropenic fever
|
4.0%
3/75 • Number of events 4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Blood and lymphatic system disorders
Bicytopenia
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
2.7%
2/75 • Number of events 2 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Gastrointestinal disorders
Vomiting and diarrhea
|
1.3%
1/75 • Number of events 2 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Gastrointestinal disorders
Microperforation of the bowel
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Gastrointestinal disorders
Bowel perforation
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Renal and urinary disorders
Acute renal failure
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Musculoskeletal and connective tissue disorders
Septic arthritis
|
2.7%
2/75 • Number of events 3 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Infections and infestations
Septic shock
|
4.0%
3/75 • Number of events 3 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Infections and infestations
Interstitial pneumonia
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Infections and infestations
Sepsis
|
17.3%
13/75 • Number of events 15 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Infections and infestations
Pneumonia
|
4.0%
3/75 • Number of events 3 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Infections and infestations
Cytomegalovirus infection
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Infections and infestations
Cytomegalovirus reactivation
|
1.3%
1/75 • Number of events 2 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Infections and infestations
Neutropenic sepsis
|
2.7%
2/75 • Number of events 2 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Infections and infestations
Adenovirus infection
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Infections and infestations
Fungal chest infection
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Infections and infestations
Respiratory syncytial virus infection
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Infections and infestations
Catheter related infection
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Infections and infestations
Tuberculosis
|
1.3%
1/75 • Number of events 1 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
Other adverse events
| Measure |
MATRIX - R-ICE - Conditioning and ASCT
n=75 participants at risk
MATRIX (courses 1,2,3): Rituximab 375 mg/m2 d0/Methotrexate 3.5 g/m2 d1/Cytarabine 2 g/m2 d2 \& d3/Thiotepa 30 mg/m2 d4/Liposomial Cytarabine 50 mg\* d5
R-ICE (courses 4,5,6):Rituximab 375 mg/m2 d1/Etoposide 100 mg/m2 d1,d2, d3/Ifosfamide 5 g/m2 d2/Carboplatin 5 AUC d2/Liposomial Cytarabine 50 mg\* d4
\*If liposomal cytarabine is not available, standard intrathecal chemotherapy with methotrexate 10 mg + cytarabine 40 mg + hydrocortisone 50 mg can be administered. Oral steroids are suggested for 2-3 days after intrathecal liposomial cytarabine delivery to prevent chemical or aseptic meningitis/ arachnoiditis.
Conditioning and ASCT: BCNU (carmustine)\*\* 400 mg/m2 d-6/Thiotepa 5 mg/kg d-5 \& d-4 ASCT: 5 x 106 CD34+cells/kg d0
\*\*In case of BCNU unavailability, the recommended conditioning regimen (Phase IV) is: Thiotepa 5 mg/kg d-6 \& d-5/Busulfan 3.2 mg/kg d-4,d -3,d-2/Clonazepam 2 mg/d d-4,d -3,d-2 ASCT: 5 x 106 CD34+cells/kg d0
|
Enrolled, But Not Treated
n=4 participants at risk
Four patients were excluded after enrolment
|
|---|---|---|
|
Vascular disorders
Vascular Disorders
|
20.0%
15/75 • Number of events 23 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Cardiac disorders
Cardiac Disorders
|
10.7%
8/75 • Number of events 16 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Nervous system disorders
Nervous System Disorders
|
32.0%
24/75 • Number of events 67 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Blood and lymphatic system disorders
Blood and Lymphatic System Disorders G3-4
|
68.0%
51/75 • Number of events 327 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
General disorders
General Disorders and Administration Site Conditions
|
73.3%
55/75 • Number of events 121 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Eye disorders
Eye Disorders
|
6.7%
5/75 • Number of events 6 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
46.7%
35/75 • Number of events 116 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Thoracic and Mediastinal Disorders
|
12.0%
9/75 • Number of events 13 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders
|
20.0%
15/75 • Number of events 15 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Renal and urinary disorders
Renal and Urinary Disorders
|
9.3%
7/75 • Number of events 12 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
|
Infections and infestations
Infections and Infestations
|
37.3%
28/75 • Number of events 65 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
0.00%
0/4 • All cause mortality was assessed through 2 years after study entry. All AEs were collected from trial inclusion until 30 days after end of treatment (7 months)
|
Additional Information
Scientific and Medical Director
International Extranodal Lymphoma Study Group (IELSG)
Phone: +41 58 666
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place