Trial Outcomes & Findings for Ibrutinib Post Stem Cell Transplantation (SCT) in Double-Hit B-Cell Lymphoma (NCT NCT02272686)
NCT ID: NCT02272686
Last Updated: 2018-12-05
Results Overview
Participants will be assessed for disease status and survival.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
Two years
Results posted on
2018-12-05
Participant Flow
Recruitment Period 6/3/2016 to 2/21/2017.
Ibrutinib maintenance will not be started if patient relapses post transplant
Participant milestones
| Measure |
Ibrutinib Maintenance
Ibrutinib maintenance after autologous stem cell transplantation (SCT) in double-hit lymphoma
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ibrutinib Post Stem Cell Transplantation (SCT) in Double-Hit B-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Ibrutinib Maintenance
n=1 Participants
Ibrutinib maintenance after autologous stem cell transplantation (SCT) in double-hit lymphoma
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Two yearsParticipants will be assessed for disease status and survival.
Outcome measures
| Measure |
Ibrutinib Maintenance
n=1 Participants
Ibrutinib maintenance after autologous stem cell transplantation (SCT) in double-hit lymphoma
|
|---|---|
|
Disease Free Survival (DFS)
|
0 Participants
|
SECONDARY outcome
Timeframe: Three YearsParticipants will be assessed at 3 year time point for survival.
Outcome measures
| Measure |
Ibrutinib Maintenance
n=1 Participants
Ibrutinib maintenance after autologous stem cell transplantation (SCT) in double-hit lymphoma
|
|---|---|
|
Overall Survival (OS)
|
1 Participants
|
Adverse Events
Ibrutinib Maintenance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Issa F. Khouri, MD, Professor, Stem Cell Transplantation
UT MD Anderson Cancer Center
Phone: 713-745-0049
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place