Trial Outcomes & Findings for Rituximab (Rituxan) for the Prevention of EBV-LPD Epstein Barr Virus (EBV) Lymphoproliferative Disorder Post T Cell Depleted Unrelated and HLA Mis-matched Related HSCT (NCT NCT00648037)

Last Updated: 2016-02-01

Results Overview

The following stopping rules will be employed to determine that the risks of graft failure, severe GvHD, treatment-related mortality, infection, and EBV-LPD in study patients are not increased over expected. In addition, patients will be removed from study if they develop irreversible non-hematologic Grade III toxicity or any Grade IV toxicity felt to be related or possibly related to study drug.

Recruitment status

COMPLETED

Study phase

Target enrollment

26 participants

Primary outcome timeframe

3 months post transplant

Results posted on

2016-02-01

Participant Flow

Participant milestones

Participant milestones
Measure	Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
Overall Study STARTED	26
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
Overall Study Not Treated	1
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	11
Overall Study Relapse	2
Overall Study Other	1

Baseline Characteristics

Rituximab (Rituxan) for the Prevention of EBV-LPD Epstein Barr Virus (EBV) Lymphoproliferative Disorder Post T Cell Depleted Unrelated and HLA Mis-matched Related HSCT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT n=26 Participants To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
Age, Categorical <=18 years	9 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months post transplant

Population: Please see Adverse Event section for more details.

Outcome measures

Outcome measures
Measure	Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT n=26 Participants To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
Safety of Rituximab Prophylaxis	23 participants

Adverse Events

Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT

Serious events: 6 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT n=26 participants at risk To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
Infections and infestations Infection w.out neutropenia	15.4% 4/26 • Number of events 4
Infections and infestations Infection with grade 3/4 neut	3.8% 1/26 • Number of events 1
Infections and infestations Neutrophils/gran	3.8% 1/26 • Number of events 2
Cardiac disorders Pericardial effusion	3.8% 1/26 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.8% 1/26 • Number of events 1

Other adverse events

Other adverse events
Measure	Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT n=26 participants at risk To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
Investigations Alkaline phosphatase	19.2% 5/26 • Number of events 18
Investigations Bilirubin	7.7% 2/26 • Number of events 3
Infections and infestations Catheter-rel inf	15.4% 4/26 • Number of events 4
General disorders Fever	7.7% 2/26 • Number of events 3
Investigations Hemoglobin (Hgb)	57.7% 15/26 • Number of events 28
Metabolism and nutrition disorders Hyperglycemia	7.7% 2/26 • Number of events 2
Metabolism and nutrition disorders Hypoalbuminemia	11.5% 3/26 • Number of events 6
Metabolism and nutrition disorders Hypocalcemia	26.9% 7/26 • Number of events 8
Metabolism and nutrition disorders Hypokalemia	26.9% 7/26 • Number of events 9
Vascular disorders Hypotension	7.7% 2/26 • Number of events 2
Infections and infestations Infection w.out neutropenia	26.9% 7/26 • Number of events 10
Investigations Leukocytes	69.2% 18/26 • Number of events 100
Investigations Lymphopenia	69.2% 18/26 • Number of events 427
Gastrointestinal disorders Nausea	7.7% 2/26 • Number of events 2
Investigations Neutrophils/gran	46.2% 12/26 • Number of events 61
Investigations Platelets	42.3% 11/26 • Number of events 62
Respiratory, thoracic and mediastinal disorders Pneumonitis	7.7% 2/26 • Number of events 2
Investigations SGOT (AST)	19.2% 5/26 • Number of events 7
Investigations SGPT (ALT)	38.5% 10/26 • Number of events 27
Gastrointestinal disorders Vomiting	7.7% 2/26 • Number of events 2

Additional Information

Papadopoulos, Esperanza, MD (Attending)

Memorial Sloan Kettering Cancer Center

Phone: +1212-639-8276

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place