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

• Sponsor: University of Oklahoma (Other)
• Overall Status: Completed
• CT.gov ID: NCT00582894
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arm: 1
• Duration (Months): 36.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hematological Neoplasms; Hematopoietic Stem Cell Transplantation	Drug: Busulfex, Fludarabine, ALemtuzumab	N/A

Detailed Description

Primary Endpoints:

1. Engraftment of donor cells

2. Regimen related toxicities

Secondary Endpoints:

1. Disease-free survival

2. Overall survival

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases
• Study Start Date: Feb 1, 2005
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: A 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	Drug: Busulfex, 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

Outcome Measures

Primary Outcome Measures

1. Number of Participants Experiencing Transplant Related Mortality (TRM) [At Day 100 post trans-plant]

2. Number of Participants Experiencing Engraftment Donor Chimerism (EDC) [At time of study termination]

Secondary Outcome Measures

1. Number of Participants Relapse-Free [100 days post-transplant]

2. Number of Participants Overall Survival as a Function of Time. [100 days post transplant]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104

Sponsors and Collaborators

• University of Oklahoma

Investigators

• Principal Investigator: George Selby, MD, University of Oklahoma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00582894
• Other Study ID Numbers: Reduced-Intensity; IRB #11835
• First Posted: Dec 28, 2007
• Last Update Posted: Apr 22, 2011
• Last Verified: Mar 1, 2011

• Keywords provided by , ,: Allogenic stem cell transplant; Hematologic diseases
• Additional relevant MeSH terms: Hematologic Neoplasms; Hematologic Diseases; Fludarabine; Alemtuzumab; Busulfan

Study Results

Participant Flow

Recruitment Details	Recruitment began February 2005 and concluded around March 2007

Arm/Group Title	Reduced Intensity Regimen
Arm/Group Description	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
Period Title: Overall Study
STARTED	17
Day 100 Post Transplant	17
COMPLETED	17
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Reduced Intensity Regimen
Arm/Group Description	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 Participants	17
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	17 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.8 (9.08)
Sex: Female, Male (Count of Participants)
Female	3 17.6%
Male	14 82.4%
Region of Enrollment (participants) [Number]
United States	17 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Experiencing Transplant Related Mortality (TRM)
Time Frame	At Day 100 post trans-plant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Reduced Intensity Regimen
Arm/Group Description	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
Measure Participants	17
Number [Participants]	0 0%

2. Secondary Outcome

Title	Number of Participants Relapse-Free
Time Frame	100 days post-transplant

Outcome Measure Data

Analysis Population Description

Last observation carried forward

Arm/Group Title	Reduced Intensity Regimen
Arm/Group Description	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
Measure Participants	17
Number [Participants]	5 29.4%

3. Primary Outcome

Title	Number of Participants Experiencing Engraftment Donor Chimerism (EDC)
Time Frame	At time of study termination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Reduced Intensity Regimen
Arm/Group Description	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
Measure Participants	17
Number [Participants]	17 100%

4. Secondary Outcome

Title	Number of Participants Overall Survival as a Function of Time.
Time Frame	100 days post transplant

Outcome Measure Data

Analysis Population Description

Last observation carried forward

Arm/Group Title	Reduced Intensity Regimen
Arm/Group Description	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
Measure Participants	17
Number [Participants]	11 64.7%

Adverse Events

Time Frame	Day 100 Post Transplant
Arm/Group Title	Reduced Intensity Regimen
Arm/Group Description	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
All Cause Mortality
	Reduced Intensity Regimen
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Reduced Intensity Regimen
	Affected / at Risk (%)	# Events
Total	1/17 (5.9%)
Vascular disorders
Intracranial hemorrhage - recurrence	1/17 (5.9%)	1
Other (Not Including Serious) Adverse Events
	Reduced Intensity Regimen
	Affected / at Risk (%)	# Events
Total	4/17 (23.5%)
Blood and lymphatic system disorders
Positive Cytomegalovirus cultures	1/17 (5.9%)	1
Thrombocytopenia	1/17 (5.9%)	1
Blasts in bone marrow	1/17 (5.9%)	1
General disorders
Syncopal episode / Hypotension	1/17 (5.9%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.