Trial Outcomes & Findings for A Clinical Trial of Cytotoxic T Cells Augmenting Autologous Hematopoietic Stem Cell (AHSC) Transplantation for Acute Myeloid Leukemia (AML) (NCT NCT00808080)

NCT ID: NCT00808080

Last Updated: 2019-04-09

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

6 participants

Primary outcome timeframe

2.5 years estimated

Results posted on

2019-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	Biologic AML\_CTL cells AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL) 6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion
Overall Study STARTED	6
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Biologic AML\_CTL cells AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL) 6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion
Overall Study Patients Became Ineligible for infusion	6

Baseline Characteristics

A Clinical Trial of Cytotoxic T Cells Augmenting Autologous Hematopoietic Stem Cell (AHSC) Transplantation for Acute Myeloid Leukemia (AML)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Biologic n=6 Participants AML\_CTL cells AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 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	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants
Percent Circulating Blasts In Peripheral Blood	52.7 percentage of peripheral blood n=5 Participants
Percent Blast Cells in Bone Marrow	67.4 percentage of bone marrow n=5 Participants
WBC at Baseline	18.4 1000 cells/mm^3 n=5 Participants
ANC at Baseline	2460.7 1000 cells/mm^3 n=5 Participants

PRIMARY outcome

Timeframe: 2.5 years estimated

Population: Not Applicable as none of the enrolled patients became eligible for infusion

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2.5 years estimated

Population: None. 6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion. No CTL infusions were administered to any subject, consequently NO outcome measure results are available.

6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion. No CTL infusions were administered to any subject, consequently NO outcome measure results are available.

Outcome measures

Outcome data not reported

Adverse Events

Biologic

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. Thomas Lane, Stem Cell Lab Director

UC San Diego Moores Cancer Center

Phone: 858-822-5364

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place