Trial Outcomes & Findings for Feasibility of Thioridazine as a Mobilizing Agent for CD34+ Hematopoietic Progenitor Cells (NCT NCT01765803)

Results Overview

To measure CD34+ cells, a peripheral blood draw is taken from the enrolled subject at hour zero on day one of the study before treatment with oral thioridazine. Following treatment, blood draws are taken at 2, 4, 8 and 24 hours. These blood samples are analyzed using Clinical Laboratory Improvement Amendments (CLIA)-approved flow cytometry for CD34+ cell content. CD34+ cell levels will be reported as a percentage of total white blood cells (WBC) in the blood specimens and the difference between baseline and 8 hours will be reported

Recruitment status

TERMINATED

Study phase

EARLY_PHASE1

Target enrollment

6 participants

Primary outcome timeframe

8 hours following treatment

Results posted on

2016-04-14

Participant Flow

Participant milestones

Participant milestones
Measure	Mellaril (Thioridazine) A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility of Thioridazine as a Mobilizing Agent for CD34+ Hematopoietic Progenitor Cells

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mellaril (Thioridazine) n=6 Participants A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment.
Age, Continuous	34 years n=99 Participants
Sex: Female, Male Female	4 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants

PRIMARY outcome

Timeframe: 8 hours following treatment

To measure CD34+ cells, a peripheral blood draw is taken from the enrolled subject at hour zero on day one of the study before treatment with oral thioridazine. Following treatment, blood draws are taken at 2, 4, 8 and 24 hours. These blood samples are analyzed using Clinical Laboratory Improvement Amendments (CLIA)-approved flow cytometry for CD34+ cell content. CD34+ cell levels will be reported as a percentage of total white blood cells (WBC) in the blood specimens and the difference between baseline and 8 hours will be reported

Outcome measures

Outcome measures
Measure	Mellaril (Thioridazine) n=6 Participants A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment.
CD34+ Progenitor Cell Mobilization CD34+ cells at baseline	0.05 percentage of total WBC count Standard Deviation 0.015
CD34+ Progenitor Cell Mobilization CD34+ cells at 8 hours	0.05 percentage of total WBC count Standard Deviation 0.018
CD34+ Progenitor Cell Mobilization Difference between baseline and 8 hours	0 percentage of total WBC count Standard Deviation 0.011

SECONDARY outcome

Timeframe: Up to 1 month after treatment

Toxicity will be evaluated according to the grading system (0-5) NCI CTCAE (Common Terminology Criteria for Adverse Events) version 4. Any subject who receives treatment on this protocol will be evaluable for toxicity.

Outcome measures

Outcome measures
Measure	Mellaril (Thioridazine) n=6 Participants A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment.
Toxicity Grade 1 somnolence	4 participants
Toxicity Returned to baseline within 24 hours	4 participants

Adverse Events

Mellaril (Thioridazine)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Mellaril (Thioridazine) n=6 participants at risk A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment.
Nervous system disorders Somnolence (Sleepiness)	66.7% 4/6 • Number of events 4

Additional Information

Stuart Winter, MD

University of New Mexico

Phone: 505-272-4461

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place