Trial Outcomes & Findings for Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases (NCT NCT00582894)

NCT ID: NCT00582894

Last Updated: 2011-04-22

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 17 participants
• Primary outcome timeframe: At Day 100 post trans-plant
• Results posted on: 2011-04-22

Participant Flow

Recruitment began February 2005 and concluded around March 2007

Participant milestones

Measure	Reduced Intensity Regimen Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
Overall Study STARTED	17
Overall Study Day 100 Post Transplant	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases

Baseline characteristics by cohort

Measure	Reduced Intensity Regimen n=17 Participants Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age Continuous	51.8 years STANDARD_DEVIATION 9.08 • n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	14 Participants n=93 Participants
Region of Enrollment United States	17 participants n=93 Participants

PRIMARY outcome

Timeframe: At Day 100 post trans-plant

Outcome measures

Measure	Reduced Intensity Regimen n=17 Participants Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
Number of Participants Experiencing Transplant Related Mortality (TRM)	0 Participants

PRIMARY outcome

Timeframe: At time of study termination

Outcome measures

Measure	Reduced Intensity Regimen n=17 Participants Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
Number of Participants Experiencing Engraftment Donor Chimerism (EDC)	17 Participants

SECONDARY outcome

Timeframe: 100 days post-transplant

Population: Last observation carried forward

Outcome measures

Measure	Reduced Intensity Regimen n=17 Participants Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
Number of Participants Relapse-Free	5 Participants

SECONDARY outcome

Timeframe: 100 days post transplant

Population: Last observation carried forward

Outcome measures

Measure	Reduced Intensity Regimen n=17 Participants Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
Number of Participants Overall Survival as a Function of Time.	11 Participants

Adverse Events

Reduced Intensity Regimen

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Reduced Intensity Regimen n=17 participants at risk Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
Vascular disorders Intracranial hemorrhage - recurrence	5.9% 1/17 • Number of events 1 • Day 100 Post Transplant

Other adverse events

Measure	Reduced Intensity Regimen n=17 participants at risk Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
Blood and lymphatic system disorders Positive Cytomegalovirus cultures	5.9% 1/17 • Number of events 1 • Day 100 Post Transplant
Blood and lymphatic system disorders Thrombocytopenia	5.9% 1/17 • Number of events 1 • Day 100 Post Transplant
Blood and lymphatic system disorders Blasts in bone marrow	5.9% 1/17 • Number of events 1 • Day 100 Post Transplant
General disorders Syncopal episode / Hypotension	5.9% 1/17 • Number of events 1 • Day 100 Post Transplant

Additional Information

George Selby, MD

University of Oklahoma Health Sciences Center

Phone: 405/271-4022

Email: george-selby@ouhsc.edu

Results disclosure agreements

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