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Completed

NCT Number: NCT00582894

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

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

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Key information

Conditions

Hematological Neoplasms Hematologic Diseases Hematologic Neoplasms Hematopoietic Stem Cell Transplantation Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

About this study

Primary Endpoints:

  • Engraftment of donor cells
  • Regimen related toxicities

Secondary Endpoints:

  • Disease-free survival
  • Overall survival

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Busulfex, Fludarabine, ALemtuzumab

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Dec 28, 2007
Registry last updated
Apr 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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