Trial Outcomes & Findings for Unrelated Cord Blood Transplant Plus a Haplo-Identical (Half-Matched), T-Cell Depleted Stem Transplant From a Related Donor for Subjects With High Risk Malignancies (NCT NCT00673114)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

3 participants

Primary outcome timeframe

By day 100

Results posted on

2015-04-03

Participant Flow

Three patients enrolled.

Participant milestones

Participant milestones
Measure	Transplant Recipients Transplant Recipients
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Unrelated Cord Blood Transplant Plus a Haplo-Identical (Half-Matched), T-Cell Depleted Stem Transplant From a Related Donor for Subjects With High Risk Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transplant Recipients n=3 Participants single arm study
Age, Categorical <=18 years	1 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	16.3 years STANDARD_DEVIATION 3.0 • n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
Region of Enrollment United States	3 participants n=99 Participants

PRIMARY outcome

Timeframe: By day 100

Outcome measures

Outcome measures
Measure	Transplant Recipients n=3 Participants single arm study
The Number of Participants Reaching Primary Endpoint of Absolute Neutrophil Count (ANC) of 500/uL (Engraftment).	3 participants

SECONDARY outcome

Timeframe: 180 days

Number of participants alive at 180 days post transplant

Outcome measures

Outcome measures
Measure	Transplant Recipients n=3 Participants single arm study
180 Day Survival	3 participants

SECONDARY outcome

Timeframe: 180 days

Outcome measures

Outcome measures
Measure	Transplant Recipients n=3 Participants single arm study
Non-Relapse Mortality at 180 Days Post Transplant	0 participants

SECONDARY outcome

Timeframe: Approximately 1 year

Participants platelet engrafted.

Outcome measures

Outcome measures
Measure	Transplant Recipients n=3 Participants single arm study
Platelet Engraftment (Untransfused and Platelet Count > 50,000)	3 participants

SECONDARY outcome

Timeframe: 100 days post transplant

Number of participants experiencing graft failure.

Outcome measures

Outcome measures
Measure	Transplant Recipients n=3 Participants single arm study
Incidence of Primary and Secondary Graft Failure	0 participants

SECONDARY outcome

Timeframe: two years

Acute and chronic GVHD

Outcome measures

Outcome measures
Measure	Transplant Recipients n=3 Participants single arm study
Number of Participants With Acute or Chronic Graft-versus-host Disease (GVHD)	2 participants

SECONDARY outcome

Timeframe: Up to 2 years post transplant

Number of participants relapsed

Outcome measures

Outcome measures
Measure	Transplant Recipients n=3 Participants single arm study
Rates of Leukemic Relapse	1 participants

SECONDARY outcome

Timeframe: Post transplant

Outcome measures

Outcome measures
Measure	Transplant Recipients n=3 Participants single arm study
Number of Participants With Donor Cells at 100 Days Post-transplant	3 participants

Adverse Events

Transplant Recipients

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Transplant Recipients n=3 participants at risk single arm study
Infections and infestations Encephalitis infection	33.3% 1/3 • Number of events 1
General disorders Chronic GVHD	33.3% 1/3 • Number of events 1
Blood and lymphatic system disorders Relapse	33.3% 1/3 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumonia	33.3% 1/3 • Number of events 1
Respiratory, thoracic and mediastinal disorders Respiratory Failure	33.3% 1/3 • Number of events 1
General disorders Multi-system organ failure	33.3% 1/3 • Number of events 1
Infections and infestations Sepsis	33.3% 1/3 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joanne Kurtzberg

Duke University Medical Center

Phone: 919-668-1100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place