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

This study has been completed.
Sponsor:
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00582894
First received: December 19, 2007
Last updated: March 23, 2011
Last verified: March 2011
  Purpose

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 Intervention
Hematological Neoplasms
Hematopoietic Stem Cell Transplantation
Drug: Busulfex, Fludarabine, ALemtuzumab

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Number of Participants Experiencing Transplant Related Mortality (TRM) [ Time Frame: At Day 100 post trans-plant ] [ Designated as safety issue: Yes ]
  • Number of Participants Experiencing Engraftment Donor Chimerism (EDC) [ Time Frame: At time of study termination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Participants Relapse-Free [ Time Frame: 100 days post-transplant ] [ Designated as safety issue: No ]
  • Number of Participants Overall Survival as a Function of Time. [ Time Frame: 100 days post transplant ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: February 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Primary Endpoints:

  1. Engraftment of donor cells
  2. Regimen related toxicities

Secondary Endpoints:

  1. Disease-free survival
  2. Overall survival
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582894

Locations
United States, Oklahoma
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
  More Information

No publications provided

Responsible Party: George Selby, MD, University of Oklahoma Health Sciences Center
ClinicalTrials.gov Identifier: NCT00582894     History of Changes
Other Study ID Numbers: Reduced-Intensity, IRB #11835
Study First Received: December 19, 2007
Results First Received: January 10, 2011
Last Updated: March 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Allogenic stem cell transplant
Hematologic diseases

Additional relevant MeSH terms:
Hematologic Diseases
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Fludarabine
Fludarabine phosphate
Alemtuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014