Trial Outcomes & Findings for In-Vivo Activated T-Cell Depletion to Prevent GVHD (NCT NCT00594308)

Results Overview

Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

until 30 days after stem cell transplant

Results posted on

2014-10-06

Participant Flow

Participant milestones

Participant milestones
Measure	Basiliximab 20 mg All patients that received Basiliximab 20 mg monoclonal therapy
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0
Overall Study STARTED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

In-Vivo Activated T-Cell Depletion to Prevent GVHD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Basiliximab 20 mg n=10 Participants All patients that received Basiliximab 20 mg monoclonal therapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	52.80 years STANDARD_DEVIATION 11.29 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: until 30 days after stem cell transplant

Population: All patient that received study drug

Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities.

Outcome measures

Outcome measures
Measure	Basiliximab 20 mg n=10 Participants All patients that received Basiliximab 20 mg monoclonal therapy
Number of Patients With Acute Grade II-IV GVHD	10 participants

SECONDARY outcome

Timeframe: until 30 days after stem cell transplant

Population: ITT population. All patient that received study drug

Outcome measures

Outcome measures
Measure	Basiliximab 20 mg n=10 Participants All patients that received Basiliximab 20 mg monoclonal therapy
Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's).	10 participants

SECONDARY outcome

Timeframe: From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion)

Population: ITT: All patient that received study drug

Average number of day per patient for absolute neutrophil count to recover(\> 500/mm3 for 3 consecutive days).

Outcome measures

Outcome measures
Measure	Basiliximab 20 mg n=10 Participants All patients that received Basiliximab 20 mg monoclonal therapy
Number of Days for Absolute Neutrophil Count to Recover	14.00 days per patient Standard Deviation 3.80

SECONDARY outcome

Timeframe: From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion)

Population: IIT: All patients that received study drug.

Average number of days per patient for resolution of cytopenias.

Outcome measures

Outcome measures
Measure	Basiliximab 20 mg n=10 Participants All patients that received Basiliximab 20 mg monoclonal therapy
Time to Resolution of Cytopenias: Platelet Transfusion Independence	15.33 days per patient Standard Deviation 3.54

SECONDARY outcome

Timeframe: up to 2 years after stem cell transplant

Population: Intent To Treat: All patients that received study drug

Number of patients who died due to transplant related toxicities

Outcome measures

Outcome measures
Measure	Basiliximab 20 mg n=10 Participants All patients that received Basiliximab 20 mg monoclonal therapy
Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria.	10 participants

Adverse Events

Basiliximab 20 mg

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Basiliximab 20 mg n=10 participants at risk All patients that received Basiliximab 20 mg monoclonal therapy
Immune system disorders GvHD	40.0% 4/10 • Number of events 4

Other adverse events

Adverse event data not reported

Additional Information

Robert Nelson, MD

Indiana University School of Medicine

Phone: 317-278-6871

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place