Trial Outcomes & Findings for Ibrutinib in Patients With Refractory/Relapsed Non-GCB Diffuse Large B-cell Lymphoma Non-candidates to ASCT (NCT NCT02692248)
NCT ID: NCT02692248
Last Updated: 2024-10-10
Results Overview
Overall Response (OR) rate (complete remission + partial response) measured by PET(Positron Emission Tomography)/CT image scan. OR will be assessed by Lugano Classification: Revised Criteria for Response Assessment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
Treatment responses will be evaluated 30 days after end of study treatment which can be occurred after 2 years and 4 months
Results posted on
2024-10-10
Participant Flow
64 patients from 15 different hospitals were registered.
Participant milestones
| Measure |
Ibrutinib -R-GEMOX-Dexa
Subjects will receive Ibrutinib with R-GEMOX-Dexa followed by Ibrutinib maintenance according to:
Induction phase:
* Rituximab 375 mg/m2 IV day 1
* Gemcitabine 1000 mg/m2 IV on day 1 or 2 (at investigator discretion).
* Oxaliplatine 100 mg/m2 on day 1 or 2 (after Gemcitabine administration);
* Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3.
* Ibrutinib 560 mg daily for 14 days.
Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days.Patients with SD and ABC profile will receive 4 additional cycles.
Maintenance phase: Responding patients will receive Ibrutinib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg daily for 14 days during induction cycles. Maintenance phase: Continuous cycles until disease progression or unacceptable toxicity (maximum of 2 years).
Rituximab: Rituximab 375 mg/m2 IV day 1 during 4 cycles.
Gemcitabine: Gemcitabine 1000 mg/m2 IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days.
Oxaliplatin: Oxaliplatin 100 mg/m2 (3-hour infusion) on day 1 or 2, after Gemcitabine infusion, 4 cycles every 14 days.
Dexamethasone: Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days.
|
|---|---|
|
Overall Study
STARTED
|
64
|
|
Overall Study
COMPLETED
|
64
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ibrutinib -R-GEMOX-Dexa
n=64 Participants
Subjects will receive Ibrutinib with R-GEMOX-Dexa followed by Ibrutinib maintenance according to:
Induction phase:
* Rituximab 375 mg/m2 IV day 1
* Gemcitabine 1000 mg/m2 IV on day 1 or 2 (at investigator discretion).
* Oxaliplatine 100 mg/m2 on day 1 or 2 (after Gemcitabine administration);
* Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3.
* Ibrutinib 560 mg daily for 14 days.
Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days.Patients with SD and ABC profile will receive 4 additional cycles.
Maintenance phase: Responding patients will receive Ibrutinib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg daily for 14 days during induction cycles. Maintenance phase: Continuous cycles until disease progression or unacceptable toxicity (maximum of 2 years).
Rituximab: Rituximab 375 mg/m2 IV day 1 during 4 cycles.
Gemcitabine: Gemcitabine 1000 mg/m2 IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days.
Oxaliplatin: Oxaliplatin 100 mg/m2 (3-hour infusion) on day 1 or 2, after Gemcitabine infusion, 4 cycles every 14 days.
Dexamethasone: Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days.
|
|---|---|
|
Age, Continuous
|
67.4 years
n=64 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=64 Participants
|
|
Region of Enrollment
Spain
|
64 participants
n=64 Participants
|
|
ECOG-PS
0
|
23 Participants
n=64 Participants
|
|
ECOG-PS
1
|
31 Participants
n=64 Participants
|
|
ECOG-PS
2
|
10 Participants
n=64 Participants
|
|
DLBCL type
DLBCL without specification
|
60 Participants
n=64 Participants
|
|
DLBCL type
DLBCL rich in T lymphocytes
|
3 Participants
n=64 Participants
|
|
DLBCL type
Follicular lymphoma
|
1 Participants
n=64 Participants
|
|
Previous lines of treatment
|
2 Previous lines of treatment
n=64 Participants
|
|
International prognostic index (IPI)
0-1
|
6 Participants
n=64 Participants
|
|
International prognostic index (IPI)
2-3
|
43 Participants
n=64 Participants
|
|
International prognostic index (IPI)
4-5
|
13 Participants
n=64 Participants
|
|
International prognostic index (IPI)
Unk
|
2 Participants
n=64 Participants
|
|
Disease stage at diagnosis
I
|
1 Participants
n=64 Participants
|
|
Disease stage at diagnosis
II
|
9 Participants
n=64 Participants
|
|
Disease stage at diagnosis
III
|
5 Participants
n=64 Participants
|
|
Disease stage at diagnosis
IV
|
46 Participants
n=64 Participants
|
|
Disease stage at diagnosis
Unk
|
3 Participants
n=64 Participants
|
|
LDH levels
Normal
|
20 Participants
n=64 Participants
|
|
LDH levels
Elevated
|
42 Participants
n=64 Participants
|
|
LDH levels
Unk
|
2 Participants
n=64 Participants
|
PRIMARY outcome
Timeframe: Treatment responses will be evaluated 30 days after end of study treatment which can be occurred after 2 years and 4 monthsOverall Response (OR) rate (complete remission + partial response) measured by PET(Positron Emission Tomography)/CT image scan. OR will be assessed by Lugano Classification: Revised Criteria for Response Assessment.
Outcome measures
| Measure |
Ibrutinib -R-GEMOX-Dexa
n=64 Participants
Subjects will receive Ibrutinib with R-GEMOX-Dexa followed by Ibrutinib maintenance according to:
Induction phase:
* Rituximab 375 mg/m2 IV day 1
* Gemcitabine 1000 mg/msq IV on day 1 or 2 (at investigator discretion).
* Oxaliplatine 100 mg/msq on day 1 or 2 (after Gemcitabine administration);
* Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3.
* Ibrutinib 560 mg daily for 14 days.
Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days.Patients with SD and ABC profile will receive 4 additional cycles.
Maintenance phase: Responding patients will receive Ibrutinib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg daily for 14 days during induction cycles. Maintenance phase: Continuous cycles until disease progression or unacceptable toxicity (maximum of 2 years).
Rituximab: Rituximab 375 mg/m2 IV day 1 during 4 cycles.
Gemcitabine: Gemcitabine 1000 mg/msq IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days.
Oxaliplatin: Oxaliplatin 100 mg/msq (3-hour infusion) on day 1 or 2, after Gemcitabine infusion, 4 cycles every 14 days.
Dexamethasone: Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days.
|
|---|---|
|
Overall Response (OR) Rate
|
36 Participants
|
SECONDARY outcome
Timeframe: Complete treatment responses will be evaluated 30 days after end of study treatment which can be occurred after 2 years and 4 monthsComplete treatment responses evaluation during 21-35 days after initiation of 6 or 8 cycle of study treatment (depend of treatment responses obtained from cycle 4) and 30 days after end of study treatment which can be occurred after 2 years and 4 months
Outcome measures
| Measure |
Ibrutinib -R-GEMOX-Dexa
n=64 Participants
Subjects will receive Ibrutinib with R-GEMOX-Dexa followed by Ibrutinib maintenance according to:
Induction phase:
* Rituximab 375 mg/m2 IV day 1
* Gemcitabine 1000 mg/msq IV on day 1 or 2 (at investigator discretion).
* Oxaliplatine 100 mg/msq on day 1 or 2 (after Gemcitabine administration);
* Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3.
* Ibrutinib 560 mg daily for 14 days.
Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days.Patients with SD and ABC profile will receive 4 additional cycles.
Maintenance phase: Responding patients will receive Ibrutinib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg daily for 14 days during induction cycles. Maintenance phase: Continuous cycles until disease progression or unacceptable toxicity (maximum of 2 years).
Rituximab: Rituximab 375 mg/m2 IV day 1 during 4 cycles.
Gemcitabine: Gemcitabine 1000 mg/msq IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days.
Oxaliplatin: Oxaliplatin 100 mg/msq (3-hour infusion) on day 1 or 2, after Gemcitabine infusion, 4 cycles every 14 days.
Dexamethasone: Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days.
|
|---|---|
|
CR Rate During Induction and Maintenance Phases.
|
25 Participants
|
SECONDARY outcome
Timeframe: Response duration will be evaluated at any time during the study when tumor response is documented or after end of study treatment which can be occurred after 2 years and 4 months.Response duration defined as the time from the documentation of tumor response to disease progression or death, in the event of no documented recurrence, or start of a new anti - lymphoma treatment because of refractory or persistent disease.
Outcome measures
| Measure |
Ibrutinib -R-GEMOX-Dexa
n=64 Participants
Subjects will receive Ibrutinib with R-GEMOX-Dexa followed by Ibrutinib maintenance according to:
Induction phase:
* Rituximab 375 mg/m2 IV day 1
* Gemcitabine 1000 mg/msq IV on day 1 or 2 (at investigator discretion).
* Oxaliplatine 100 mg/msq on day 1 or 2 (after Gemcitabine administration);
* Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3.
* Ibrutinib 560 mg daily for 14 days.
Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days.Patients with SD and ABC profile will receive 4 additional cycles.
Maintenance phase: Responding patients will receive Ibrutinib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg daily for 14 days during induction cycles. Maintenance phase: Continuous cycles until disease progression or unacceptable toxicity (maximum of 2 years).
Rituximab: Rituximab 375 mg/m2 IV day 1 during 4 cycles.
Gemcitabine: Gemcitabine 1000 mg/msq IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days.
Oxaliplatin: Oxaliplatin 100 mg/msq (3-hour infusion) on day 1 or 2, after Gemcitabine infusion, 4 cycles every 14 days.
Dexamethasone: Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days.
|
|---|---|
|
Response Duration
|
6.5 months
Interval 0.0 to 38.3
|
SECONDARY outcome
Timeframe: Progression free survival will be evaluated at any time during the study when first documentation of recurrence, progression, or death or after end of study treatment which can be occurred after 2 years and 4 monthsProgression free survival defined as the time between start of treatment and the first documentation of recurrence, progression, or death in the event of no documented recurrence, or start of a new anti - lymphoma treatment, due a refractory or persistent disease. Progression is defined using Lugano Classification for response assessment for Non-Hodgkin Lymphoma, defined as Score of 4 or 5 with an increase in uptake intensity over baseline period for Individual lymph nodes/target lymph node masses; New areas of FDG avidity consistent with lymphoma at mid- or end-of-treatment assessment for Extranodal injuries; new injuries; New or recurrent areas of FDG avidity in bone marrow.
Outcome measures
| Measure |
Ibrutinib -R-GEMOX-Dexa
n=64 Participants
Subjects will receive Ibrutinib with R-GEMOX-Dexa followed by Ibrutinib maintenance according to:
Induction phase:
* Rituximab 375 mg/m2 IV day 1
* Gemcitabine 1000 mg/msq IV on day 1 or 2 (at investigator discretion).
* Oxaliplatine 100 mg/msq on day 1 or 2 (after Gemcitabine administration);
* Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3.
* Ibrutinib 560 mg daily for 14 days.
Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days.Patients with SD and ABC profile will receive 4 additional cycles.
Maintenance phase: Responding patients will receive Ibrutinib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg daily for 14 days during induction cycles. Maintenance phase: Continuous cycles until disease progression or unacceptable toxicity (maximum of 2 years).
Rituximab: Rituximab 375 mg/m2 IV day 1 during 4 cycles.
Gemcitabine: Gemcitabine 1000 mg/msq IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days.
Oxaliplatin: Oxaliplatin 100 mg/msq (3-hour infusion) on day 1 or 2, after Gemcitabine infusion, 4 cycles every 14 days.
Dexamethasone: Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days.
|
|---|---|
|
Progression Free Survival
|
4.1 months
Interval 2.2 to 6.1
|
SECONDARY outcome
Timeframe: 2 years and 4 months.Population: There was 1 (1.6%) patient that ended treatment due to the onset of a new neoplasia but did not require a new therapeutic strategy and was not considered as an EFS event.
Event-free survival defined as the time between start of treatment and the first documentation of adverse events and serious adverse events graded according to NCI CTCAE v4.0
Outcome measures
| Measure |
Ibrutinib -R-GEMOX-Dexa
n=63 Participants
Subjects will receive Ibrutinib with R-GEMOX-Dexa followed by Ibrutinib maintenance according to:
Induction phase:
* Rituximab 375 mg/m2 IV day 1
* Gemcitabine 1000 mg/msq IV on day 1 or 2 (at investigator discretion).
* Oxaliplatine 100 mg/msq on day 1 or 2 (after Gemcitabine administration);
* Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3.
* Ibrutinib 560 mg daily for 14 days.
Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days.Patients with SD and ABC profile will receive 4 additional cycles.
Maintenance phase: Responding patients will receive Ibrutinib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg daily for 14 days during induction cycles. Maintenance phase: Continuous cycles until disease progression or unacceptable toxicity (maximum of 2 years).
Rituximab: Rituximab 375 mg/m2 IV day 1 during 4 cycles.
Gemcitabine: Gemcitabine 1000 mg/msq IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days.
Oxaliplatin: Oxaliplatin 100 mg/msq (3-hour infusion) on day 1 or 2, after Gemcitabine infusion, 4 cycles every 14 days.
Dexamethasone: Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days.
|
|---|---|
|
Event-free Survival
|
4.03 months
Interval 2.5 to 5.6
|
SECONDARY outcome
Timeframe: 2 yearsOverall survival is defined as the time between the start of treatment and death from any cause. Patients that are withdrawn from the trial or lost of follow-up, will be censored with the date of last contact. Patients who are still alive at the end of the study will be censored at that time.
Outcome measures
| Measure |
Ibrutinib -R-GEMOX-Dexa
n=64 Participants
Subjects will receive Ibrutinib with R-GEMOX-Dexa followed by Ibrutinib maintenance according to:
Induction phase:
* Rituximab 375 mg/m2 IV day 1
* Gemcitabine 1000 mg/msq IV on day 1 or 2 (at investigator discretion).
* Oxaliplatine 100 mg/msq on day 1 or 2 (after Gemcitabine administration);
* Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3.
* Ibrutinib 560 mg daily for 14 days.
Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days.Patients with SD and ABC profile will receive 4 additional cycles.
Maintenance phase: Responding patients will receive Ibrutinib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg daily for 14 days during induction cycles. Maintenance phase: Continuous cycles until disease progression or unacceptable toxicity (maximum of 2 years).
Rituximab: Rituximab 375 mg/m2 IV day 1 during 4 cycles.
Gemcitabine: Gemcitabine 1000 mg/msq IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days.
Oxaliplatin: Oxaliplatin 100 mg/msq (3-hour infusion) on day 1 or 2, after Gemcitabine infusion, 4 cycles every 14 days.
Dexamethasone: Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days.
|
|---|---|
|
Overall Survival
|
11.67 months
Interval 7.0 to 16.3
|
SECONDARY outcome
Timeframe: 2 years and 4 monthsPopulation: percentage of patients that present AE related to the treatment
Safety and tolerability will be assessed during any phase of study treatment and 30 days after end of study treatment which can be occurred after 2 years and 4 months and will be classified according to the Common Toxicity CNC
Outcome measures
| Measure |
Ibrutinib -R-GEMOX-Dexa
n=64 Participants
Subjects will receive Ibrutinib with R-GEMOX-Dexa followed by Ibrutinib maintenance according to:
Induction phase:
* Rituximab 375 mg/m2 IV day 1
* Gemcitabine 1000 mg/msq IV on day 1 or 2 (at investigator discretion).
* Oxaliplatine 100 mg/msq on day 1 or 2 (after Gemcitabine administration);
* Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3.
* Ibrutinib 560 mg daily for 14 days.
Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days.Patients with SD and ABC profile will receive 4 additional cycles.
Maintenance phase: Responding patients will receive Ibrutinib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg daily for 14 days during induction cycles. Maintenance phase: Continuous cycles until disease progression or unacceptable toxicity (maximum of 2 years).
Rituximab: Rituximab 375 mg/m2 IV day 1 during 4 cycles.
Gemcitabine: Gemcitabine 1000 mg/msq IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days.
Oxaliplatin: Oxaliplatin 100 mg/msq (3-hour infusion) on day 1 or 2, after Gemcitabine infusion, 4 cycles every 14 days.
Dexamethasone: Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days.
|
|---|---|
|
Percentage of Participants That Present Treatment-Related Adverse Events Oxaliplatin and Dexamethasone
|
55 Participants
|
Adverse Events
Ibrutinib -R-GEMOX-Dexa
Serious events: 33 serious events
Other events: 63 other events
Deaths: 46 deaths
Serious adverse events
| Measure |
Ibrutinib -R-GEMOX-Dexa
n=64 participants at risk
Subjects will receive Ibrutinib with R-GEMOX-Dexa followed by Ibrutinib maintenance according to:
Induction phase:
* Rituximab 375 mg/m2 IV day 1
* Gemcitabine 1000 mg/msq IV on day 1 or 2 (at investigator discretion).
* Oxaliplatine 100 mg/msq on day 1 or 2 (after Gemcitabine administration);
* Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3.
* Ibrutinib 560 mg daily for 14 days.
Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days.Patients with SD and ABC profile will receive 4 additional cycles.
Maintenance phase: Responding patients will receive Ibrutinib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg daily for 14 days during induction cycles. Maintenance phase: Continuous cycles until disease progression or unacceptable toxicity (maximum of 2 years).
Rituximab: Rituximab 375 mg/m2 IV day 1 during 4 cycles.
Gemcitabine: Gemcitabine 1000 mg/msq IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days.
Oxaliplatin: Oxaliplatin 100 mg/msq (3-hour infusion) on day 1 or 2, after Gemcitabine infusion, 4 cycles every 14 days.
Dexamethasone: Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea - Grade 3
|
3.1%
2/64 • Number of events 64 • 2 years and 4 months
|
|
General disorders
Fever - Grade 3
|
3.1%
2/64 • Number of events 64 • 2 years and 4 months
|
|
Gastrointestinal disorders
Abdominal pain - Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Nervous system disorders
Akathisia - Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Blood and lymphatic system disorders
Anemia - Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain - Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Nervous system disorders
Confusion - Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Gastrointestinal disorders
Diarrhoea - Grade 2
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Gastrointestinal disorders
Dysphagia - Grade 2
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
General disorders
Fatigue - Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia - Grade 2
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia - Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
General disorders
Fever - Grade 1
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
General disorders
Fever - Grade 2
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
General disorders
Flu like symptoms - Grade 2
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Injury, poisoning and procedural complications
Fracture - Grade 3
|
3.1%
2/64 • Number of events 64 • 2 years and 4 months
|
|
Gastrointestinal disorders
Gastroenteritis - Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
General disorders
Clinical deterioration - Grade 5
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Cardiac disorders
Heart failure - Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Blood and lymphatic system disorders
Hematoma - Grade 2
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Injury, poisoning and procedural complications
Hip fracture Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Cardiac disorders
Hypotension - Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Infections and infestations
Herpes zoster - Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Infections and infestations
Candidiasis - Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Injury, poisoning and procedural complications
Patient took expired medication - GradeUK
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Infections and infestations
Lung infection - Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Infections and infestations
Lung infection - Grade 5
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
General disorders
Malaise - Grade 5
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal tumor - Grade 4
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
General disorders
Pain - Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Cardiac disorders
Pericardial tamponade - Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Cardiac disorders
Pericarditis - Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion - Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure - Grade 3
|
3.1%
2/64 • Number of events 64 • 2 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure - Grade 5
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Partial respiratory failure-Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Infections and infestations
Sepsis - Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Infections and infestations
Septic shock - Grade 5
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Nervous system disorders
Transient ischemic attacks - Grade 2
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor lysis syndrome - Grade 4
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Infections and infestations
Upper respiratory infection - Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Infections and infestations
Upper respiratory infection - Grade 5
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Infections and infestations
Urinary tract infection - Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Infections and infestations
Urinary tract infection - Grade 4
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Vascular disorders
Subarachnoid hemorrhage - Grade 2
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Gastrointestinal disorders
Vomiting - Grade 2
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
|
Gastrointestinal disorders
Vomiting - Grade 3
|
1.6%
1/64 • Number of events 64 • 2 years and 4 months
|
Other adverse events
| Measure |
Ibrutinib -R-GEMOX-Dexa
n=64 participants at risk
Subjects will receive Ibrutinib with R-GEMOX-Dexa followed by Ibrutinib maintenance according to:
Induction phase:
* Rituximab 375 mg/m2 IV day 1
* Gemcitabine 1000 mg/msq IV on day 1 or 2 (at investigator discretion).
* Oxaliplatine 100 mg/msq on day 1 or 2 (after Gemcitabine administration);
* Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3.
* Ibrutinib 560 mg daily for 14 days.
Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days.Patients with SD and ABC profile will receive 4 additional cycles.
Maintenance phase: Responding patients will receive Ibrutinib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity.
Ibrutinib: Ibrutinib 560 mg daily for 14 days during induction cycles. Maintenance phase: Continuous cycles until disease progression or unacceptable toxicity (maximum of 2 years).
Rituximab: Rituximab 375 mg/m2 IV day 1 during 4 cycles.
Gemcitabine: Gemcitabine 1000 mg/msq IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days.
Oxaliplatin: Oxaliplatin 100 mg/msq (3-hour infusion) on day 1 or 2, after Gemcitabine infusion, 4 cycles every 14 days.
Dexamethasone: Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days.
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|---|---|
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Blood and lymphatic system disorders
Platelet count decreased
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60.9%
39/64 • Number of events 64 • 2 years and 4 months
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
34.4%
22/64 • Number of events 64 • 2 years and 4 months
|
|
Gastrointestinal disorders
Diarrhoea
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31.2%
20/64 • Number of events 64 • 2 years and 4 months
|
|
Blood and lymphatic system disorders
Anemia
|
21.9%
14/64 • Number of events 64 • 2 years and 4 months
|
|
General disorders
Nausea
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21.9%
14/64 • Number of events 64 • 2 years and 4 months
|
|
Blood and lymphatic system disorders
Lymphocyte count decrease
|
15.6%
10/64 • Number of events 64 • 2 years and 4 months
|
|
Gastrointestinal disorders
Vomiting
|
9.4%
6/64 • Number of events 64 • 2 years and 4 months
|
|
Nervous system disorders
Paresthesia
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12.5%
8/64 • Number of events 64 • 2 years and 4 months
|
|
General disorders
Fatigue
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10.9%
7/64 • Number of events 64 • 2 years and 4 months
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
6.2%
4/64 • Number of events 64 • 2 years and 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60