Trial Outcomes & Findings for Ibrutinib Plus Rituximab for cGVHD Following Allo-SCT (NCT NCT03689894)
NCT ID: NCT03689894
Last Updated: 2023-11-28
Results Overview
During dose escalation, subjects will be assessed for dose-limiting toxicities at each dose level.
TERMINATED
PHASE1/PHASE2
2 participants
Start of treatment through Week 4 of treatment
2023-11-28
Participant Flow
All participants were recruited at a single site, Dartmouth-Hitchcock Norris Cotton Cancer Center in Lebanon New Hampshire. Recruitment extended throughout the life of the study from 4/11/2019 to 07/22/2021.
Participant milestones
| Measure |
Ibrutinib Plus Rituximab
Rituximab
\*375 milligrams (mg) per meter squared intravenous infusion weekly for 4 (may repeat 8 weeks after initial therapy, if suboptimal response)
Ibrutinib
420 mg (140 mg capsule x3) by mouth daily May be given beyond 3-6 months (for maintenance).
|
|---|---|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
|
Overall Study
STARTED
|
2
|
|
Overall Study
Completed Study Treatment
|
1
|
Reasons for withdrawal
| Measure |
Ibrutinib Plus Rituximab
Rituximab
\*375 milligrams (mg) per meter squared intravenous infusion weekly for 4 (may repeat 8 weeks after initial therapy, if suboptimal response)
Ibrutinib
420 mg (140 mg capsule x3) by mouth daily May be given beyond 3-6 months (for maintenance).
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Ibrutinib Plus Rituximab for cGVHD Following Allo-SCT
Baseline characteristics by cohort
| Measure |
Ibrutinib Plus Rituximab
n=2 Participants
Rituximab
\*375 milligrams (mg) per meter squared intravenous infusion weekly for 4 (may repeat 8 weeks after initial therapy, if suboptimal response)
Ibrutinib
420 mg (140 mg capsule x3) by mouth daily May be given beyond 3-6 months (for maintenance).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Start of treatment through Week 4 of treatmentPopulation: 0 patients analyzed. 1 patient withdrawn early and 1 patient not complaint with study procedures.
During dose escalation, subjects will be assessed for dose-limiting toxicities at each dose level.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeks, 3 months, and 6 months after initiation of treatmentPopulation: Subject 1 off study before 6 week assessment due to study drug possibly related rash SAE.
Response rate of clinically significant GVHD will be assessed using NIH criteria (from 2014 NIH Consensus Development Project).
Outcome measures
| Measure |
Ibrutinib Plus Rituximab
n=1 Participants
Rituximab
\*375 milligrams (mg) per meter squared intravenous infusion weekly for 4 (may repeat 8 weeks after initial therapy, if suboptimal response)
Ibrutinib
420 mg (140 mg capsule x3) by mouth daily May be given beyond 3-6 months (for maintenance).
|
|---|---|
|
Assess the Response Rate of cGVHD to Treatment With Ibrutinib Plus Rituximab
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 weeks, 3 months, and 6 months after initiation of treatmentPopulation: Laboratory correlates for this study were not processed or analyzed for any subject enrolled onto this study.
Plasma ST2 and CD4CD25FOXp3 correlates will be measured at identified intervals to determine if either correlate demonstrates an affect on clinical response.
Outcome measures
Outcome data not reported
Adverse Events
Ibrutinib Plus Rituximab
Serious adverse events
| Measure |
Ibrutinib Plus Rituximab
n=2 participants at risk
Rituximab
\*375 milligrams (mg) per meter squared intravenous infusion weekly for 4 (may repeat 8 weeks after initial therapy, if suboptimal response)
Ibrutinib
* 420 mg (140 mg capsule x3) by mouth daily
* May be given beyond 3-6 months (for maintenance).
Ibrutinib: Subjects will receive oral (PO) Ibrutinib 140 mg once daily with Rituximab 375 mg per meter squared IV weekly x4 (with pre-medications and infusion procedure as per standard protocol) Rituximab Pre-medications:Acetaminophen 650 mg PO; Diphenhydramine 25 mg PO/IV; Dexamethasone 20 mg IV.
If no adverse events \>Grade 3+ are noted after 1 week, the Ibrutinib dose schedule will be increased to 280 mg daily. If no adverse events \>Gr3+ are noted after an additional 1 week, the Ibrutinib dose will be increased to 420 mg daily.
Rituximab: Subject will receive an intravenous infusion of 375mg per meter squared weekly for 4 weeks, which may be repeated 8 weeks after initial therapy if only a suboptimal response is achieved.
|
|---|---|
|
General disorders
Rash
|
50.0%
1/2 • Number of events 1 • Participant #1: Assessed over a period of 5 weeks (Time on study 4/12/2019 - 10/14/2019) Participant #2: Assessed over a period of 28 weeks (Time on study 7/29/2020 - 2/10/2021)
|
Other adverse events
Adverse event data not reported
Additional Information
Director of Clinical Research
Dartmouth Hitchcock Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place