Trial Outcomes & Findings for Ibrutinib in Treating Patients With Refractory or Relapsed Lymphoma After Donor Stem Cell Transplant (NCT NCT02869633)
NCT ID: NCT02869633
Last Updated: 2023-10-23
Results Overview
The progression free survival (PFS) is defined as time to progression, or relapse of the underlying disease for which transplant was undertaken, or death from any non-relapse causes, starting from the date of stem cell transplant (SCT). This will be restricted to patients in cohort A which includes the diagnoses of CLL and MCL, only, and patients treated with ibrutinib. Twelve-month PFS probability with 95% confidence interval will be estimated using Kaplan-Meier method. This probability range between 0 and 1, and the higher the better.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Time to progression, or relapse of the underlying disease for which transplant was undertaken, or death from any non-relapse causes, assessed 12 months post HCT.
Results posted on
2023-10-23
Participant Flow
This study recruited participants from September 2016 through October 2019 at six medical centers.
Participant milestones
| Measure |
Cohort A - Chronic Lymphocytic Leukemia (CLL) Mantle Cell Lymphoma (MCL)
60-90 days after donor stem cell transplant participants take Ibrutinib by mouth until 1 year after stem cell transplant.
|
Cohort B - Follicular Lymphoma (FL) /Hodgkin Lymphoma (HL) Lymphoma (HL) Cohort
60-90 days after donor stem cell transplant participants take Ibrutinib by mouth until 1 year after stem cell transplant.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
7
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
13
|
5
|
Reasons for withdrawal
| Measure |
Cohort A - Chronic Lymphocytic Leukemia (CLL) Mantle Cell Lymphoma (MCL)
60-90 days after donor stem cell transplant participants take Ibrutinib by mouth until 1 year after stem cell transplant.
|
Cohort B - Follicular Lymphoma (FL) /Hodgkin Lymphoma (HL) Lymphoma (HL) Cohort
60-90 days after donor stem cell transplant participants take Ibrutinib by mouth until 1 year after stem cell transplant.
|
|---|---|---|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Patient refused follow-up
|
1
|
0
|
|
Overall Study
Provider discretion
|
1
|
0
|
|
Overall Study
Investigator decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Not eligible
|
6
|
1
|
|
Overall Study
Protocol-defined follow-up period completed
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Ibrutinib in Treating Patients With Refractory or Relapsed Lymphoma After Donor Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Cohort A - CLL/MC
n=16 Participants
60-90 days after donor stem cell transplant participants take Ibrutinib by mouth until 1 year after stem cell transplant.
|
Cohort B - FL/HL Cohort
n=7 Participants
60-90 days after donor stem cell transplant participants take Ibrutinib by mouth until 1 year after stem cell transplant.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
7 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time to progression, or relapse of the underlying disease for which transplant was undertaken, or death from any non-relapse causes, assessed 12 months post HCT.Population: Cohort A - CLL/MCL patients treated with ibrutinib starting between day 60 and day 90 after allogeneic HCT
The progression free survival (PFS) is defined as time to progression, or relapse of the underlying disease for which transplant was undertaken, or death from any non-relapse causes, starting from the date of stem cell transplant (SCT). This will be restricted to patients in cohort A which includes the diagnoses of CLL and MCL, only, and patients treated with ibrutinib. Twelve-month PFS probability with 95% confidence interval will be estimated using Kaplan-Meier method. This probability range between 0 and 1, and the higher the better.
Outcome measures
| Measure |
Cohort A - CLL/MCL
n=7 Participants
60-90 days after donor stem cell transplant participants take Ibrutinib by mouth until 1 year after stem cell transplant.
|
Cohort B - Follicular Lymphoma (FL) /Hodgkin Lymphoma (HL) Lymphoma (HL) Cohort
60-90 days after donor stem cell transplant participants take Ibrutinib by mouth until 1 year after stem cell transplant.
|
|---|---|---|
|
Progression Free Survival Probability at 12-month Post HCT
|
0.80 probability
Interval 0.2 to 0.97
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Data not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Data not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Data not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Data not collected
Outcome measures
Outcome data not reported
Adverse Events
Cohort A - CLL/MCL
Serious events: 12 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort B - FL/HL Cohort
Serious events: 5 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort A - CLL/MCL
n=16 participants at risk
60-90 days after donor stem cell transplant participants take Ibrutinib by mouth until 1 year after stem cell transplant.
|
Cohort B - FL/HL Cohort
n=7 participants at risk
60-90 days after donor stem cell transplant participants take Ibrutinib by mouth until 1 year after stem cell transplant.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
43.8%
7/16 • Number of events 8 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
14.3%
1/7 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
2/16 • Number of events 2 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
14.3%
1/7 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 3 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
General disorders
Fever
|
12.5%
2/16 • Number of events 3 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
42.9%
3/7 • Number of events 3 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
General disorders
Flu-Like Symptoms
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
General disorders
Pain
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Infections and infestations
Enterocolitis infectious
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Infections and infestations
Lung infection
|
12.5%
2/16 • Number of events 2 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Infections and infestations
Sepsis
|
18.8%
3/16 • Number of events 3 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
14.3%
1/7 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Infections and infestations
Tooth infection
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Infections and infestations
Upper respiratory infection
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Nervous system disorders
Ataxia
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
14.3%
1/7 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
14.3%
1/7 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Vascular disorders
Deep Vein Thrombosis
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/16 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
14.3%
1/7 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
14.3%
1/7 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Psychiatric disorders
Altered Mental State
|
0.00%
0/16 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
14.3%
1/7 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
12.5%
2/16 • Number of events 2 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.00%
0/16 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
14.3%
1/7 • Number of events 2 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/16 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
14.3%
1/7 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/16 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
14.3%
1/7 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
General disorders
Death
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Infections and infestations
Catheter-related Infection - MRSA
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
Other adverse events
| Measure |
Cohort A - CLL/MCL
n=16 participants at risk
60-90 days after donor stem cell transplant participants take Ibrutinib by mouth until 1 year after stem cell transplant.
|
Cohort B - FL/HL Cohort
n=7 participants at risk
60-90 days after donor stem cell transplant participants take Ibrutinib by mouth until 1 year after stem cell transplant.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
18.8%
3/16 • Number of events 100 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
28.6%
2/7 • Number of events 2 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Investigations
Platelet count decreased
|
18.8%
3/16 • Number of events 10 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
14.3%
1/7 • Number of events 4 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Investigations
Neutrophil count decreased
|
12.5%
2/16 • Number of events 9 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
14.3%
1/7 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Investigations
White blood cell decreased
|
12.5%
2/16 • Number of events 8 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
14.3%
1/7 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/16 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
28.6%
2/7 • Number of events 2 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
18.8%
3/16 • Number of events 4 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
28.6%
2/7 • Number of events 2 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
2/16 • Number of events 2 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
14.3%
1/7 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Gastrointestinal disorders
Vomitting
|
12.5%
2/16 • Number of events 2 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
14.3%
1/7 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
2/16 • Number of events 3 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
14.3%
1/7 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Gastrointestinal disorders
Mucositis, oral
|
6.2%
1/16 • Number of events 3 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Gastrointestinal disorders
Rectal pain
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Nervous system disorders
Paresthesia
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Nervous system disorders
Tremor
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
General disorders
Fatigue
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
General disorders
Malaise
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Injury, poisoning and procedural complications
Bruising
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Psychiatric disorders
Restlessness
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
14.3%
1/7 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/16 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
14.3%
1/7 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/16 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
14.3%
1/7 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.2%
1/16 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
0.00%
0/7 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
|
General disorders
Infusion-related rection
|
6.2%
1/16 • Number of events 2 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
14.3%
1/7 • Number of events 1 • Time frame for serious adverse events and other (Not Including Serious) Adverse Events: Time of consent until 30 days post cessation of study drugs up to 1 year. Time frame for All-Cause Mortality Table = Time of informed consent to off-study date, up to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place