Trial Outcomes & Findings for Trial Of Double Umbilical Cord Blood Transplantation (NCT NCT00763490)
NCT ID: NCT00763490
Last Updated: 2016-12-23
Results Overview
One-year survival rate after transplant
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
1 year
Results posted on
2016-12-23
Participant Flow
Participant milestones
| Measure |
Double Cord Blood Tranplant
Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial Of Double Umbilical Cord Blood Transplantation
Baseline characteristics by cohort
| Measure |
Double Cord Blood Tranplant
n=20 Participants
Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
|
|---|---|
|
Age, Continuous
|
41 years
n=5 Participants
|
|
Gender
Female
|
9 Participants
n=5 Participants
|
|
Gender
Male
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearOne-year survival rate after transplant
Outcome measures
| Measure |
Double Cord Blood Tranplant
n=20 Participants
Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
|
|---|---|
|
Percentage of Participants Alive at 1 Year After Transplant
|
40 percentage of participants
Interval 19.0 to 60.0
|
SECONDARY outcome
Timeframe: 5 YearsEvent Free Survival (EFS) was determined. Patients were followed up to 5 years (median time of 2.35 years).
Outcome measures
| Measure |
Double Cord Blood Tranplant
n=20 Participants
Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
|
|---|---|
|
Percentage of Patients Alive at the End of the Trial
|
35 percentage of patients
Interval 16.0 to 55.0
|
SECONDARY outcome
Timeframe: Day 35The failure to achieve a neutrophil count \> 500/uL or a platelet count \>30.0 x 10e9 /L within 35 days of the stem cell infusion will be defined as primary engraftment failure.
Outcome measures
| Measure |
Double Cord Blood Tranplant
n=20 Participants
Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
|
|---|---|
|
Cumulative Incidence of Neutrophil and Platelet Engraftment
Cumulative incidence of platlet engraftment
|
73 percentage of participants
Interval 48.0 to 88.0
|
|
Cumulative Incidence of Neutrophil and Platelet Engraftment
Cumulative incidence of neutrophil engraftment
|
89 percentage of participants
Interval 64.0 to 97.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsThe percentage of patients with acute GVHD (Grade II-IV) was determined at 100 days. Patients were followed up to 5 years and the percentage of patients that developed chronic GVHD at the end of the study was tabulated. Acute GVHD is staged and graded (grade 0-IV, where grade 0 is no involvement and involvement increases by grade) by the number and extent of organ involvement. Patients can have involvement of three organs: skin (rash/dermatitis), liver (hepatitis/jaundice), and gastrointestinal tract (abdominal pain/diarrhea).
Outcome measures
| Measure |
Double Cord Blood Tranplant
n=20 Participants
Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
|
|---|---|
|
Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD)
Acute GVHD (Grades II-IV)
|
40 percentage of patients
Interval 19.0 to 60.0
|
|
Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD)
Chronic GVHD
|
35 percentage of patients
Interval 16.0 to 65.0
|
Adverse Events
Double Cord Blood Tranplant
Serious events: 14 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double Cord Blood Tranplant
n=20 participants at risk
Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
|
|---|---|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
15.0%
3/20 • Number of events 3
|
|
Cardiac disorders
Hypotension
|
10.0%
2/20 • Number of events 2
|
|
General disorders
Fever
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Anorexia
|
15.0%
3/20 • Number of events 3
|
|
Gastrointestinal disorders
Hemorrhage, GI
|
5.0%
1/20 • Number of events 2
|
|
Infections and infestations
Infection with normal ANC
|
10.0%
2/20 • Number of events 2
|
|
Nervous system disorders
Confusion
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Syncope (fainting)
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
5.0%
1/20 • Number of events 1
|
|
Renal and urinary disorders
Bladder spasms
|
5.0%
1/20 • Number of events 1
|
|
Renal and urinary disorders
Cystitis
|
10.0%
2/20 • Number of events 2
|
|
General disorders
Syndromes - Other
|
5.0%
1/20 • Number of events 1
|
Other adverse events
| Measure |
Double Cord Blood Tranplant
n=20 participants at risk
Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
|
|---|---|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
15.0%
3/20 • Number of events 3
|
|
Cardiac disorders
Hypertension
|
10.0%
2/20 • Number of events 2
|
|
Cardiac disorders
Hypotension
|
30.0%
6/20 • Number of events 6
|
|
Investigations
Weight gain
|
10.0%
2/20 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
10.0%
2/20 • Number of events 2
|
|
Gastrointestinal disorders
Anorexia
|
15.0%
3/20 • Number of events 3
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
10.0%
2/20 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory
|
10.0%
2/20 • Number of events 2
|
|
Infections and infestations
Infection with normal ANC
|
15.0%
3/20 • Number of events 3
|
|
Nervous system disorders
Confusion
|
20.0%
4/20 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal Pain
|
15.0%
3/20 • Number of events 3
|
|
Nervous system disorders
Head Pain
|
20.0%
4/20 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
10.0%
2/20 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
15.0%
3/20 • Number of events 3
|
|
Renal and urinary disorders
Cystitis
|
10.0%
2/20 • Number of events 2
|
Additional Information
Dr. Daniel Couriel, M.D.
University of Michigan Comprehensive Cancer Center
Phone: 734-936-8785
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place