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Allogeneic Transplantation From Related Haploidentical Donors in Older Patients With Indolent Hematologic Malignancies

Information source: Stanford University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Blood Cancer; Leukemia

Intervention: non-myeloablative hematopoietic cell transplantation (Procedure); Anti-Thymocyte Globulin (Drug); Cyclosporine (Drug); Mycophenolate Mofetil (Drug); G-CSF (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Stanford University

Official(s) and/or principal investigator(s):
Robert Lowsky, Principal Investigator, Affiliation: Stanford University

Summary

The purpose of the study is to evaluate the feasibility and safety of transplanting CD34+ selected hematopoietic cells from a haploidentical related donor following a nonmyeloablative regimen of total lymphoid irradiation (TLI) and antithymocyte globulin (ATG).

Clinical Details

Official title: 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

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

Primary outcome: 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

Detailed description: 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.

Eligibility

Minimum age: 12 Months. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- a haploidentical donor is available

Exclusion Criteria:

- rapidly progressive disease

- organ dysfunction

- documented fungal disease

- HIV positive

Locations and Contacts

Stanford University School of Medicine, Stanford, California 94305, United States
Additional Information

Starting date: August 2000
Last updated: January 30, 2015

Page last updated: August 20, 2015

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