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

Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00582894
• Other study ID #: Reduced-Intensity
• Secondary ID: IRB #11835
• Status: Completed
• Phase: N/A
• First received: December 19, 2007
• Last updated: March 23, 2011
• Start date: February 2005
• Est. completion date: March 2008

Study information

• Verified date: March 2011
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Description:

Primary Endpoints:

1. Engraftment of donor cells

2. Regimen related toxicities

Secondary Endpoints:

1. Disease-free survival

2. Overall survival

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematologic Diseases
• Hematologic Neoplasms
• Hematological Neoplasms
• Hematopoietic Stem Cell Transplantation

Intervention

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

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Transplant Related Mortality (TRM)		At Day 100 post trans-plant	Yes
Primary	Number of Participants Experiencing Engraftment Donor Chimerism (EDC)		At time of study termination	Yes
Secondary	Number of Participants Relapse-Free		100 days post-transplant	No
Secondary	Number of Participants Overall Survival as a Function of Time.		100 days post transplant	No