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


N/A
18 Years
75 Years
Not Enrolling
Both
Hematological Neoplasms, Hematopoietic Stem Cell Transplantation

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Trial Information

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


Primary Endpoints:

1. Engraftment of donor cells

2. Regimen related toxicities

Secondary Endpoints:

1. Disease-free survival

2. Overall survival


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants Experiencing Transplant Related Mortality (TRM)

Outcome Time Frame:

At Day 100 post trans-plant

Safety Issue:

Yes

Principal Investigator

George Selby, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Oklahoma

Authority:

United States: Institutional Review Board

Study ID:

Reduced-Intensity

NCT ID:

NCT00582894

Start Date:

February 2005

Completion Date:

March 2008

Related Keywords:

  • Hematological Neoplasms
  • Hematopoietic Stem Cell Transplantation
  • Allogenic stem cell transplant
  • Hematologic diseases
  • Neoplasms
  • Hematologic Diseases
  • Hematologic Neoplasms

Name

Location

University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104