Trial Outcomes & Findings for Chemotherapy, Radiation Therapy, Rituximab, and Umbilical Cord Blood Transplant in Treating Patients With B-Cell Non-Hodgkin's Lymphoma (NCT NCT00387959)
NCT ID: NCT00387959
Last Updated: 2016-02-01
Results Overview
The number of patients survival status 1 year after transplantation
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
1 Year after transplant
Results posted on
2016-02-01
Participant Flow
Participant milestones
| Measure |
Unrelated Donor Umbilical Cord Transplant
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemotherapy, Radiation Therapy, Rituximab, and Umbilical Cord Blood Transplant in Treating Patients With B-Cell Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Unrelated Donor Umbilical Cord Transplant
n=17 Participants
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 Year after transplantThe number of patients survival status 1 year after transplantation
Outcome measures
| Measure |
Unrelated Donor Umbilical Cord Transplant
n=16 Participants
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
|
|---|---|
|
Survival at 1 Year After Transplantation
Alive at 1 Year Post Transplant
|
10 participants
|
|
Survival at 1 Year After Transplantation
Died Prior to 1 Year Post Transplant
|
6 participants
|
Adverse Events
Unrelated Donor Umbilical Cord Transplant
Serious events: 9 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Unrelated Donor Umbilical Cord Transplant
n=16 participants at risk
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
|
|---|---|
|
Blood and lymphatic system disorders
Blood/Bone Marrow, other
|
6.2%
1/16 • Number of events 16
|
|
General disorders
Death not assoc w CTCAE term- Death NOS
|
37.5%
6/16 • Number of events 6
|
|
General disorders
Death not assoc w CTCAE term- Multi-organ failure
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
6.2%
1/16 • Number of events 1
|
Other adverse events
| Measure |
Unrelated Donor Umbilical Cord Transplant
n=16 participants at risk
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
|
|---|---|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
18.8%
3/16 • Number of events 3
|
|
Blood and lymphatic system disorders
ALT, SGPT
|
25.0%
4/16 • Number of events 4
|
|
Blood and lymphatic system disorders
AST, SGOT
|
12.5%
2/16 • Number of events 2
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
12.5%
2/16 • Number of events 2
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
62.5%
10/16 • Number of events 10
|
|
Metabolism and nutrition disorders
Calcium, high (hypercalcemia)
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Creatinine
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
62.5%
10/16 • Number of events 10
|
|
Blood and lymphatic system disorders
Hemoglobin
|
87.5%
14/16 • Number of events 14
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
100.0%
16/16 • Number of events 16
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
16/16 • Number of events 16
|
|
Metabolism and nutrition disorders
Magnesium, high (hypermagnesemia)
|
31.2%
5/16 • Number of events 5
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
100.0%
16/16 • Number of events 16
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
68.8%
11/16 • Number of events 11
|
|
Blood and lymphatic system disorders
Platelets
|
100.0%
16/16 • Number of events 16
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
31.2%
5/16 • Number of events 5
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
37.5%
6/16 • Number of events 6
|
|
Blood and lymphatic system disorders
Partial thromboplastin time (PTT)
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
50.0%
8/16 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
12.5%
2/16 • Number of events 2
|
Additional Information
Dr. Juliet Barker
Memorial Sloan Kettering Cancer Center
Phone: 212-639-3468
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place