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

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ClinicalTrials.gov Identifier: NCT00582894
Recruitment Status : Completed
First Posted : December 28, 2007
Results First Posted : April 22, 2011
Last Update Posted : April 22, 2011
Sponsor:
Information provided by:
University of Oklahoma

Study Description
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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 Not Applicable

Detailed Description:

Primary Endpoints:

  1. Engraftment of donor cells
  2. Regimen related toxicities

Secondary Endpoints:

  1. Disease-free survival
  2. Overall survival
Study Design
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Study Type : Interventional  (Clinical Trial)
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 : February 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Disorders

Arms and Interventions
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Arm Intervention/treatment
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
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Primary Outcome Measures :
  1. Number of Participants Experiencing Transplant Related Mortality (TRM) [ Time Frame: At Day 100 post trans-plant ]
  2. Number of Participants Experiencing Engraftment Donor Chimerism (EDC) [ Time Frame: At time of study termination ]

Secondary Outcome Measures :
  1. Number of Participants Relapse-Free [ Time Frame: 100 days post-transplant ]
  2. Number of Participants Overall Survival as a Function of Time. [ Time Frame: 100 days post transplant ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582894


Locations
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United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
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Principal Investigator: George Selby, MD University of Oklahoma
More Information
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Responsible Party: George Selby, MD, University of Oklahoma Health Sciences Center
ClinicalTrials.gov Identifier: NCT00582894    
Other Study ID Numbers: Reduced-Intensity
IRB #11835 ( Other Identifier: University of Oklahoma Health Sciences Center )
First Posted: December 28, 2007    Key Record Dates
Results First Posted: April 22, 2011
Last Update Posted: April 22, 2011
Last Verified: March 2011
Keywords provided by University of Oklahoma:
Allogenic stem cell transplant
Hematologic diseases
Additional relevant MeSH terms:
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Hematologic Neoplasms
Hematologic Diseases
Neoplasms by Site
Neoplasms
Fludarabine
Alemtuzumab
Busulfan
Antineoplastic Agents
 Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Alkylating Agents
Antineoplastic Agents, Alkylating
Myeloablative Agonists