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Allogeneic Hematopoietic Cell Transplantation of Positively Selected CD34+ Cells and Defined Inoculum of T Cells From Related Haploidentical Donors for Older Patients With Indolent Hematologic Malignancies


Phase 2
12 Months
80 Years
Not Enrolling
Both
Blood Cancer, Leukemia

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Trial Information

Allogeneic Hematopoietic Cell Transplantation of Positively Selected CD34+ Cells and Defined Inoculum of T Cells From Related Haploidentical Donors for Older Patients With Indolent Hematologic Malignancies


The purpose of the study is to assess safety and feasibility of using a non-myeloablative
conditioning regimen of total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG)
to achieve engraftment of haploidentical CD34+ selected peripheral blood stem cells in older
patients or patients with underlying medical conditions that preclude standard allogeneic
treatment.


Inclusion Criteria:



- a haploidentical donor is available

Exclusion Criteria:

- rapidly progressive disease

- organ dysfunction

- documented fungal disease

- HIV positive

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess safety and feasibility of using a non-myeloablative conditioning regimen of total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG) to achieve engraftment of haploidentical CD34+ selected peripheral blood stem cells in older patients or

Outcome Time Frame:

1st 100 days after transplant and yearly intervals thereafter

Safety Issue:

Yes

Principal Investigator

Robert Lowsky

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

BMT124

NCT ID:

NCT00185692

Start Date:

August 2000

Completion Date:

December 2010

Related Keywords:

  • Blood Cancer
  • Leukemia
  • Leukemia
  • Hematologic Neoplasms

Name

Location
Stanford University School of Medicine Stanford, California  94305-5317