Trial Outcomes & Findings for Cellular Therapy With Cord Blood Cells (NCT NCT00427557)
NCT ID: NCT00427557
Last Updated: 2012-05-28
Results Overview
Engraftment defined as first of three (3) consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 \* 10\^9/L; assessed from baseline to 100 days post-engraftment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Baseline to 100 days post-engraftment
Results posted on
2012-05-28
Participant Flow
Recruitment Period: January 05, 2007 to November 05, 2010. All recruitment done at UT MD Anderson Cancer Center.
One participant of the 31 was enrolled but did not receive treatment.
Participant milestones
| Measure |
Cellular Therapy With Cord Blood Cells
Fludarabine 30 mg/m\^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m\^2 IV for 1 Day + Rituximab 375 mg/m\^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cellular Therapy With Cord Blood Cells
Baseline characteristics by cohort
| Measure |
Cellular Therapy With Cord Blood Cells
n=30 Participants
Fludarabine 30 mg/m\^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m\^2 IV for 1 Day + Rituximab 375 mg/m\^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
|
|---|---|
|
Age Continuous
|
44 years
STANDARD_DEVIATION 17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 100 days post-engraftmentPopulation: Analysis per protocol.
Engraftment defined as first of three (3) consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 \* 10\^9/L; assessed from baseline to 100 days post-engraftment.
Outcome measures
| Measure |
Fludarabine + Melphalan + Umbilical Cord Blood Unit
n=30 Participants
Fludarabine 30 mg/m\^2 given daily for four days. Melphalan 140 mg/m\^2 given for one day. Umbilical Cord Blood Unit given on one day.
|
|---|---|
|
Number of Participants With Engraftment
|
27 participants
|
Adverse Events
Cellular Therapy With Cord Blood Cells
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cellular Therapy With Cord Blood Cells
n=30 participants at risk
Fludarabine 30 mg/m\^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m\^2 IV for 1 Day + Rituximab 375 mg/m\^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
|
|---|---|
|
Renal and urinary disorders
Acute Renal Failure
|
6.7%
2/30 • Number of events 2 • 10 Years and 3 Months
|
|
General disorders
Graft Failure
|
3.3%
1/30 • Number of events 1 • 10 Years and 3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
6.7%
2/30 • Number of events 2 • 10 Years and 3 Months
|
|
Nervous system disorders
Ischemic Stroke
|
3.3%
1/30 • Number of events 1 • 10 Years and 3 Months
|
Other adverse events
| Measure |
Cellular Therapy With Cord Blood Cells
n=30 participants at risk
Fludarabine 30 mg/m\^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m\^2 IV for 1 Day + Rituximab 375 mg/m\^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
|
|---|---|
|
General disorders
Graft vs Host Disease
|
73.3%
22/30 • Number of events 41 • 10 Years and 3 Months
|
|
Eye disorders
Blurry Vision
|
6.7%
2/30 • Number of events 2 • 10 Years and 3 Months
|
|
General disorders
Delayed Engraftment
|
6.7%
2/30 • Number of events 2 • 10 Years and 3 Months
|
|
Blood and lymphatic system disorders
Thrombotic Thrombocytopenia Purpura
|
6.7%
2/30 • Number of events 2 • 10 Years and 3 Months
|
|
Cardiac disorders
Congestive Heart Failure
|
10.0%
3/30 • Number of events 3 • 10 Years and 3 Months
|
|
Cardiac disorders
Myocarditis
|
3.3%
1/30 • Number of events 1 • 10 Years and 3 Months
|
|
Cardiac disorders
Cardiomyopathy
|
3.3%
1/30 • Number of events 1 • 10 Years and 3 Months
|
|
Cardiac disorders
Hypertension
|
20.0%
6/30 • Number of events 6 • 10 Years and 3 Months
|
|
Cardiac disorders
Low Blood Pressure
|
3.3%
1/30 • Number of events 1 • 10 Years and 3 Months
|
|
Cardiac disorders
Tachycardia
|
3.3%
1/30 • Number of events 1 • 10 Years and 3 Months
|
|
Blood and lymphatic system disorders
Hemolytic Anemia
|
3.3%
1/30 • Number of events 1 • 10 Years and 3 Months
|
|
General disorders
Fever
|
70.0%
21/30 • Number of events 21 • 10 Years and 3 Months
|
|
General disorders
Fatigue
|
6.7%
2/30 • Number of events 2 • 10 Years and 3 Months
|
|
General disorders
Fluid Overload
|
13.3%
4/30 • Number of events 4 • 10 Years and 3 Months
|
|
Gastrointestinal disorders
Diarrhea
|
46.7%
14/30 • Number of events 14 • 10 Years and 3 Months
|
|
Gastrointestinal disorders
Mucositis
|
70.0%
21/30 • Number of events 21 • 10 Years and 3 Months
|
|
Gastrointestinal disorders
GastrointestinaI Bleed
|
6.7%
2/30 • Number of events 2 • 10 Years and 3 Months
|
|
Gastrointestinal disorders
Nausea
|
100.0%
30/30 • Number of events 30 • 10 Years and 3 Months
|
|
Renal and urinary disorders
Elevated Creatinine
|
6.7%
2/30 • Number of events 2 • 10 Years and 3 Months
|
|
Renal and urinary disorders
Hemorrhagic Cystitis
|
26.7%
8/30 • Number of events 8 • 10 Years and 3 Months
|
|
Hepatobiliary disorders
Elevated Liver Function Tests
|
40.0%
12/30 • Number of events 12 • 10 Years and 3 Months
|
|
Hepatobiliary disorders
Veno Occulusive Disease
|
3.3%
1/30 • Number of events 1 • 10 Years and 3 Months
|
|
Infections and infestations
Infection
|
73.3%
22/30 • Number of events 45 • 10 Years and 3 Months
|
|
General disorders
Encephalopathy
|
6.7%
2/30 • Number of events 2 • 10 Years and 3 Months
|
|
General disorders
Headache
|
10.0%
3/30 • Number of events 3 • 10 Years and 3 Months
|
|
Nervous system disorders
Neuropathy
|
3.3%
1/30 • Number of events 1 • 10 Years and 3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.3%
1/30 • Number of events 1 • 10 Years and 3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse Alveolar Hemorrhage
|
13.3%
4/30 • Number of events 4 • 10 Years and 3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
16.7%
5/30 • Number of events 5 • 10 Years and 3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
3.3%
1/30 • Number of events 1 • 10 Years and 3 Months
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
26.7%
8/30 • Number of events 8 • 10 Years and 3 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place