Trial Outcomes & Findings for Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders (NCT NCT00801931)

NCT ID: NCT00801931

Last Updated: 2019-03-27

Results Overview

Number of patients to experience graft failure.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2019-03-27

Participant Flow

There was only 1 subjected enrolled. The 1 subject was enrolled into Arm - Experimental: C: Moderate Intensity.

Participant milestones

Participant milestones
Measure	Experimental: C: Moderate Intensity Patients will start their GVHD prophylaxis with Tacrolimus on Day -8. Patients will receive busulfan twice daily on Days -8, -7, -6, and -5; fludarabine on Days -7, -6, -5, -4, -3 and -2 and alemtuzumab on Days -5, -4, -3, -2, and -1. The double cord blood infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus/MMF.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: C: Moderate Intensity n=1 Participants Patients will start their GVHD prophylaxis with Tacrolimus on Day -8. Patients will receive busulfan twice daily on Days -8, -7, -6, and -5; fludarabine on Days -7, -6, -5, -4, -3 and -2 and alemtuzumab on Days -5, -4, -3, -2, and -1. The double cord blood infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus/MMF.
Age, Categorical <=18 years	1 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	0 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
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Population: Not enough subjects were enrolled for data analysis.

Number of patients to experience graft failure.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 2 years

Population: Not enough subjects were enrolled for data analysis.

Response rate to each regimen will be measured.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 2 years

Population: Not enough subjects were enrolled for data analysis.

OS will be summarized using the Kaplan and Meier curves.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 2 years

Population: Not enough subjects were enrolled for data analysis.

DFS will be summarized using the Kaplan and Meier curves.

Outcome measures

Outcome data not reported

Adverse Events

Experimental: C: Moderate Intensity

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Experimental: C: Moderate Intensity n=1 participants at risk Patients will start their GVHD prophylaxis with Tacrolimus on Day -8. Patients will receive busulfan twice daily on Days -8, -7, -6, and -5; fludarabine on Days -7, -6, -5, -4, -3 and -2 and alemtuzumab on Days -5, -4, -3, -2, and -1. The double cord blood infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus/MMF.
Respiratory, thoracic and mediastinal disorders Respiratory Failure with Cardiac Tamponade	100.0% 1/1 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Prakash Satwani, MD

Columbia University

Phone: 212-305-0223

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place