Trial Outcomes & Findings for Rituximab After Autologous Stem Cell Transplant for Relapsed B-cell Non-Hodgkin's Lymphoma (NCT NCT00225212)

Results Overview

"Events" for EFS were defined as the earlier of post-ASCT relapse or death.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

24 months

Results posted on

2014-09-15

Participant milestones
Measure	Rituximab After ASCT Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
Overall Study STARTED	35
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	6

Reasons for withdrawal
Measure	Rituximab After ASCT Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
Overall Study Disease progression	2
Overall Study Death	1
Overall Study Adverse Event	2
Overall Study Intercurrent illness	1

Rituximab After Autologous Stem Cell Transplant for Relapsed B-cell Non-Hodgkin's Lymphoma

Baseline characteristics by cohort
Measure	Rituximab After ASCT n=35 Participants Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
Age, Customized aged 16 and older	51 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Lymphoma sub-types Diffuse large B-cell lymphoma (DLCL)	25 participants n=5 Participants
Lymphoma sub-types Mantle cell lymphoma (MCL)	3 participants n=5 Participants
Lymphoma sub-types Transformed lymphoma	3 participants n=5 Participants
Lymphoma sub-types Other B-cell lymphoma	4 participants n=5 Participants

Timeframe: 24 months

"Events" for EFS were defined as the earlier of post-ASCT relapse or death.

Outcome measures
Measure	Rituximab After ASCT n=35 Participants Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
Event-free Survival (EFS)	83 percentage of not experiencing EFS event Interval 70.0 to 95.0

Timeframe: 24 months

Outcome measures
Measure	Rituximab After ASCT n=35 Participants Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
Overall Survival (OS)	88 percentage of subjects remaining alive Interval 78.0 to 99.0

Serious events: 33 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events
Measure	Rituximab After ASCT n=35 participants at risk Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, neutropenia	54.3% 19/35 • Number of events 45
Blood and lymphatic system disorders Febrile Neutropenia	2.9% 1/35 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumonitis, BCNU-related	20.0% 7/35 • Number of events 7
General disorders Death NOS, pneumonitis	2.9% 1/35 • Number of events 1
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, Community acquired pneumonia	11.4% 4/35 • Number of events 4
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.9% 1/35 • Number of events 1

Other adverse events
Measure	Rituximab After ASCT n=35 participants at risk Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, neutropenia	5.7% 2/35 • Number of events 2
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, Thrombocytopenia	8.6% 3/35 • Number of events 3
Blood and lymphatic system disorders Anemia	11.4% 4/35 • Number of events 4

Stanford University Medical Center

Phone: 650-723-6456