This phase II clinical trial studies donor stem cell transplant in treating patients with hematological malignancies. Giving chemotherapy and total body irradiation before a donor bone marrow transplant or peripheral blood stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Removing the T cells from the donor cells before transplant may stop this from happening.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01189786.
Locations matching your search criteria
United States
Texas
Houston
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterStatus: Active
Contact: Robert Allen Krance
Phone: 832-824-4661
Center for Cell and Gene TherapyStatus: Active
Contact: Robert Allen Krance
Texas Children's HospitalStatus: Active
Contact: Robert Allen Krance
PRIMARY OBJECTIVES:
I. To estimate the rate of primary engraftment, early post stem cell transplant (SCT) toxicity and incidence of graft-versus-host disease (GvHD) in recipients of granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood stem cells depleted of T cells by positive selection for the cluster of differentiation (CD)34 antigen. (Cohort 1)
II. The 100-days post SCT incidence rate of overall acute GvHD ≥ grade 3. (Cohort 2)
SECONDARY OBJECTIVES:
I. To determine the long term survival of recipients of G-CSF mobilized peripheral blood stem cells depleted of T cells by positive selection for the CD34+ antigen.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT 1 (stem cell transplant with conditioning): Patients receive conditioning regimen at the discretion of the treating physician and undergo T-cell depleted, CD34+ selected allogeneic hematopoietic stem cell transplantation (HSCT).
COHORT 2 (CD34+ top-off without conditioning): Patients may receive conditioning regimen at the discretion of the treating physician and undergo T-cell depleted, CD34+ selected allogeneic HSCT.
After completion of study treatment, patients are followed up for 1 year.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorRobert Allen Krance