Trial Outcomes & Findings for Cord Blood Transplantation for Patients With Cancer (NCT NCT01359254)
NCT ID: NCT01359254
Last Updated: 2015-04-30
Results Overview
Percent of subjects with cord blood engraftment on or before day 100. Detectable cord blood engraftment should be present by day 100 in at least 50% of patients. As of 44 days post-transplant, only haploidentical donor chimerism achieved in the one patient enrolled in the Fludarabine, melphalan, and ATG arm. There were no cord cells detected for this patient.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
100 days
Results posted on
2015-04-30
Participant Flow
Participant milestones
| Measure |
Fludarabine, Melphalan, and ATG
Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)
Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.
Fludarabine: Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.
|
Fludarabine, Busulfan, ATG, and TBI
Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
Fludarabine: Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.
Busulfan: Busulfan is given daily for 4 days.
Total Body Irradiation (TBI): TBI is given twice on the last day.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Fludarabine, Melphalan, and ATG
Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)
Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.
Fludarabine: Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.
|
Fludarabine, Busulfan, ATG, and TBI
Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
Fludarabine: Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.
Busulfan: Busulfan is given daily for 4 days.
Total Body Irradiation (TBI): TBI is given twice on the last day.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Cord Blood Transplantation for Patients With Cancer
Baseline characteristics by cohort
| Measure |
Fludarabine, Melphalan, and ATG
n=1 Participants
Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)
Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.
Fludarabine: Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.
|
Fludarabine, Busulfan, ATG, and TBI
Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
Fludarabine: Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.
Busulfan: Busulfan is given daily for 4 days.
Total Body Irradiation (TBI): TBI is given twice on the last day.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Gender
Female
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Gender
Male
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 100 daysPopulation: The only enrolled patient failed to complete the study due to death.
Percent of subjects with cord blood engraftment on or before day 100. Detectable cord blood engraftment should be present by day 100 in at least 50% of patients. As of 44 days post-transplant, only haploidentical donor chimerism achieved in the one patient enrolled in the Fludarabine, melphalan, and ATG arm. There were no cord cells detected for this patient.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 100 daysPopulation: The only enrolled patient failed to complete the study due to death.
Percent of subjects who are alive 100 days after the stem cell infusion
Outcome measures
Outcome data not reported
Adverse Events
Fludarabine, Melphalan, and ATG
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Fludarabine, Busulfan, ATG, and TBI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fludarabine, Melphalan, and ATG
n=1 participants at risk
Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)
Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.
Fludarabine: Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.
|
Fludarabine, Busulfan, ATG, and TBI
Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
Fludarabine: Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.
Busulfan: Busulfan is given daily for 4 days.
Total Body Irradiation (TBI): TBI is given twice on the last day.
|
|---|---|---|
|
General disorders
Septic shock
|
100.0%
1/1 • 100 days
|
—
0/0 • 100 days
|
|
Renal and urinary disorders
Renal failure
|
100.0%
1/1 • 100 days
|
—
0/0 • 100 days
|
Other adverse events
| Measure |
Fludarabine, Melphalan, and ATG
n=1 participants at risk
Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)
Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.
Fludarabine: Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.
|
Fludarabine, Busulfan, ATG, and TBI
Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
Fludarabine: Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.
Busulfan: Busulfan is given daily for 4 days.
Total Body Irradiation (TBI): TBI is given twice on the last day.
|
|---|---|---|
|
General disorders
Acute graft versus host disease
|
100.0%
1/1 • 100 days
|
—
0/0 • 100 days
|
Additional Information
Andrew Artz, MD, MS
The University of Chicago Medicine
Phone: (773) 834-8980
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place