Trial Outcomes & Findings for Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Cytomegalovirus (CMV) Reactivation (NCT NCT02210065)

NCT ID: NCT02210065

Last Updated: 2020-03-17

Results Overview

Non-relapse mortality defined as death because of causes other than relapse of the underlying hematological malignancy.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

6 months

Results posted on

2020-03-17

Participant Flow

All participants were registered in UT MD Anderson Cancer Center.

Five participants did not receive treatment as either they did not have CMV reactivation or had relapse of their primary malignancy and received treatment for relapse.

Participant milestones

Participant milestones
Measure	Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs) CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg. Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs): CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Cytomegalovirus (CMV) Reactivation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs) n=1 Participants CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg. Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs): CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	1 participants n=93 Participants

PRIMARY outcome

Timeframe: 6 months

Non-relapse mortality defined as death because of causes other than relapse of the underlying hematological malignancy.

Outcome measures

Outcome measures
Measure	Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs) n=1 Participants CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg. Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs): CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.
Number of Participants With Non-Relapse Mortality	0 Participants

PRIMARY outcome

Timeframe: 28 days

Treatment considered a success if the patient does not require initiation of cytomegalovirus (CMV) anti-viral therapy.

Outcome measures

Outcome measures
Measure	Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs) n=1 Participants CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg. Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs): CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.
Success Rate of Cytotoxic T Cells	1 Participants

Adverse Events

Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Betul Oran / Associate Professor, Stem Cell Transplantation

U.T. MD Anderson Cancer Center

Phone: 713-745-2820

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place