Trial Outcomes & Findings for Infliximab and Basiliximab for Treatment of Steroid Refractory Acute Graft Versus Host Disease (NCT NCT01485055)

Results Overview

Complete response was defined as complete resolution of all signs and symptoms of GvHD in all organs using the Modified Glucksberg grading of acute graft versus host disease scale. The score used for GvHD grading complete response was "0" in all evaluable organs.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

28 days

Results posted on

2019-04-05

Participant Flow

Participant milestones

Participant milestones
Measure	Infliximab and Basiliximab Other Names: Simulect Remicade Monoclonal antibody Participants in this research study will receive combination therapy (2 drugs: Infliximab and Basiliximab)once a week for four weeks. Both drugs will be given through the participant's broviac, port or through a vein in the arm. It will take about 4-5 hours to complete the 2-drug combination therapy each week. Participants will be given pre-medications to help prevent reactions to the study drugs. Infliximab will be given at a dose of 10mg per Kg per dose. Basiliximab will be given in 10mg doses to patients who weigh less than 35kg. Patients who weigh weigh more than 35kg will receive 20mg doses. Patients will receive both drugs weekly on days 1,8,15 and 22. Each drug will be given 4 times. Infliximab and Basiliximab: Participants in this research study will receive combination therapy (2 drugs: Infliximab and Basiliximab)once a week for four weeks.
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Infliximab and Basiliximab for Treatment of Steroid Refractory Acute Graft Versus Host Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infliximab and Basiliximab n=11 Participants Other Names: Simulect Remicade Monoclonal antibody Participants in this research study will receive combination therapy (2 drugs: Infliximab and Basiliximab)once a week for four weeks. Both drugs will be given through the participant's broviac, port or through a vein in the arm. It will take about 4-5 hours to complete the 2-drug combination therapy each week. Participants will be given pre-medications to help prevent reactions to the study drugs. Infliximab will be given at a dose of 10mg per Kg per dose. Basiliximab will be given in 10mg doses to patients who weigh less than 35kg. Patients who weigh weigh more than 35kg will receive 20mg doses. Patients will receive both drugs weekly on days 1,8,15 and 22. Each drug will be given 4 times. Infliximab and Basiliximab: Participants in this research study will receive combination therapy (2 drugs: Infliximab and Basiliximab)once a week for four weeks.
Age, Categorical <=18 years	8 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: The study was closed prematurely as the study sponsor could not supply the medication any further. The study had not enrolled enough subjects to do a valid statistical analysis

Complete response was defined as complete resolution of all signs and symptoms of GvHD in all organs using the Modified Glucksberg grading of acute graft versus host disease scale. The score used for GvHD grading complete response was "0" in all evaluable organs.

Outcome measures

Outcome measures
Measure	Infliximab and Basiliximab n=10 Participants Other Names: Simulect Remicade Monoclonal antibody Participants in this research study will receive combination therapy (2 drugs: Infliximab and Basiliximab)once a week for four weeks. Both drugs will be given through the participant's broviac, port or through a vein in the arm. It will take about 4-5 hours to complete the 2-drug combination therapy each week. Participants will be given pre-medications to help prevent reactions to the study drugs. Infliximab will be given at a dose of 10mg per Kg per dose. Basiliximab will be given in 10mg doses to patients who weigh less than 35kg. Patients who weigh weigh more than 35kg will receive 20mg doses. Patients will receive both drugs weekly on days 1,8,15 and 22. Each drug will be given 4 times. Infliximab and Basiliximab: Participants in this research study will receive combination therapy (2 drugs: Infliximab and Basiliximab)once a week for four weeks.
Complete Response Rate Determination	10 Participants

Adverse Events

Infliximab and Basiliximab

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Infliximab and Basiliximab n=11 participants at risk Participants in this research study will receive combination therapy (2 drugs: Infliximab and Basiliximab)once a week for four weeks. Both drugs will be given through the participant's broviac, port or through a vein in the arm. It will take about 4-5 hours to complete the 2-drug combination therapy each week. Participants will be given pre-medications to help prevent reactions to the study drugs. Infliximab will be given at a dose of 10mg per Kg per dose. Basiliximab will be given in 10mg doses to patients who weigh less than 35kg. Patients who weigh weigh more than 35kg will receive 20mg doses. Patients will receive both drugs weekly on days 1,8,15 and 22. Each drug will be given 4 times.
Hepatobiliary disorders ALT	9.1% 1/11 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Rajinder Bajwa

Nationwide Childrens Hospital

Phone: 6147222000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place