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

Primary Purpose

Hematological Neoplasms, Hematopoietic Stem Cell Transplantation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Busulfex, Fludarabine, ALemtuzumab
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematological Neoplasms focused on measuring Allogenic stem cell transplant, Hematologic diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Oklahoma Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

A

Arm 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

Outcomes

Primary Outcome Measures

Number of Participants Experiencing Transplant Related Mortality (TRM)
Number of Participants Experiencing Engraftment Donor Chimerism (EDC)

Secondary Outcome Measures

Number of Participants Relapse-Free
Number of Participants Overall Survival as a Function of Time.

Full Information

First Posted
December 19, 2007
Last Updated
March 23, 2011
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT00582894
Brief Title
Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases
Official Title
Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Oklahoma

4. Oversight

Data Monitoring Committee
Yes

5. 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
Detailed Description
Primary Endpoints: Engraftment of donor cells Regimen related toxicities Secondary Endpoints: Disease-free survival Overall survival

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Neoplasms, Hematopoietic Stem Cell Transplantation
Keywords
Allogenic stem cell transplant, Hematologic diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm 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
Intervention Type
Drug
Intervention Name(s)
Busulfex, Fludarabine, ALemtuzumab
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Transplant Related Mortality (TRM)
Time Frame
At Day 100 post trans-plant
Title
Number of Participants Experiencing Engraftment Donor Chimerism (EDC)
Time Frame
At time of study termination
Secondary Outcome Measure Information:
Title
Number of Participants Relapse-Free
Time Frame
100 days post-transplant
Title
Number of Participants Overall Survival as a Function of Time.
Time Frame
100 days post transplant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Selby, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

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

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