Hematological Neoplasms, Hematopoietic Stem Cell Transplantation
Conditions
Keywords
Allogenic stem cell transplant, Hematologic diseases
Brief summary
To evaluate engraftment and toxicity of a reduced intensity preparative regimen for patients who receive a matched related or unrelated donor allogeneic stem cell transplant (ASCT) for malignant hematological diseases
Detailed description
Primary Endpoints: 1. Engraftment of donor cells 2. Regimen related toxicities Secondary Endpoints: 1. Disease-free survival 2. Overall survival
Interventions
DRUGBusulfex, Fludarabine, ALemtuzumab
Busulfex 3.2 mg/kg/day for 2 days infused over 3 hours, Days -6 and Day-5 Fludarabine 30 mg/m2/day for 5 days on Day -6 to D-2 Alemtuzumab 10 mg/day IV on Days -5 to -1
Sponsors
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Performance status 0-2 * Ejection fraction \> 30% * AST/ALT and bilirubin not \> 4 times normal * Creatinine clearance greater than 70 ml/min. * FEV1 greater than 1.0 and diffusion capacity greater than 40% * Age 18-75 years * Patients must be at high risk for conventional regimen related toxicity * Malignant hematologic disease that would otherwise be considered treatable with ASCT
Exclusion criteria
* Does not meet the above Inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Experiencing Transplant Related Mortality (TRM) | At Day 100 post trans-plant |
| Number of Participants Experiencing Engraftment Donor Chimerism (EDC) | At time of study termination |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Relapse-Free | 100 days post-transplant |
| Number of Participants Overall Survival as a Function of Time. | 100 days post transplant |
Countries
United States
Participant flow
Recruitment details
Recruitment began February 2005 and concluded around March 2007
Participants by arm
| Arm | Count |
|---|---|
| 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 | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Reduced Intensity Regimen |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age Continuous | 51.8 years STANDARD_DEVIATION 9.08 |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 17 |
| serious Total, serious adverse events | 1 / 17 |
Outcome results
Primary
Number of Participants Experiencing Engraftment Donor Chimerism (EDC)
Time frame: At time of study termination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reduced Intensity Regimen | Number of Participants Experiencing Engraftment Donor Chimerism (EDC) | 17 Participants |
Primary
Number of Participants Experiencing Transplant Related Mortality (TRM)
Time frame: At Day 100 post trans-plant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reduced Intensity Regimen | Number of Participants Experiencing Transplant Related Mortality (TRM) | 0 Participants |
Secondary
Number of Participants Overall Survival as a Function of Time.
Time frame: 100 days post transplant
Population: Last observation carried forward
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reduced Intensity Regimen | Number of Participants Overall Survival as a Function of Time. | 11 Participants |
Secondary
Number of Participants Relapse-Free
Time frame: 100 days post-transplant
Population: Last observation carried forward
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reduced Intensity Regimen | Number of Participants Relapse-Free | 5 Participants |