Trial Outcomes & Findings for Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Diseases (NCT NCT00453206)

NCT ID: NCT00453206

Last Updated: 2018-09-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 66 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2018-09-10

Participant Flow

Participant milestones

Measure	Reduced Intensity Allogeneic Cell Transplantation reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
Overall Study STARTED	66
Overall Study COMPLETED	65
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Reduced Intensity Allogeneic Cell Transplantation reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
Overall Study Death	1

Baseline Characteristics

Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Diseases

Baseline characteristics by cohort

Measure	Reduced Intensity Allogeneic Cell Transplantation n=66 Participants reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
Age, Continuous	60.1 years STANDARD_DEVIATION 7.5 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	64 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	65 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	66 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Reduced Intensity Allogeneic Cell Transplantation n=65 Participants reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
Treatment-related Mortality Within the First 6 Months After Transplantation	6 participants

SECONDARY outcome

Timeframe: monthly

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: monthly

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: monthly

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: monthly

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 100 days

Outcome measures

Outcome data not reported

Adverse Events

Reduced Intensity Allogeneic Cell Transplantation

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Reduced Intensity Allogeneic Cell Transplantation n=65 participants at risk reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
Immune system disorders Graft versus host disease	4.6% 3/65 • Number of events 3 • The only adverse events collected and analyzed for this study were grade 5 (death) related to transplant occurring within 6 months of transplant. No data was collected for less serious adverse events.
Immune system disorders Post transplant proliferative disorder	1.5% 1/65 • Number of events 1 • The only adverse events collected and analyzed for this study were grade 5 (death) related to transplant occurring within 6 months of transplant. No data was collected for less serious adverse events.
Nervous system disorders Neurological unspecified	1.5% 1/65 • Number of events 1 • The only adverse events collected and analyzed for this study were grade 5 (death) related to transplant occurring within 6 months of transplant. No data was collected for less serious adverse events.
General disorders Death of unknown cause	1.5% 1/65 • Number of events 1 • The only adverse events collected and analyzed for this study were grade 5 (death) related to transplant occurring within 6 months of transplant. No data was collected for less serious adverse events.

Other adverse events

Adverse event data not reported

Additional Information

David Hurd, MD

Wake Forest University Health Sciences

Phone: 336-716-2843

Email: dhurd@wakehealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place