NCT00185692

Allogeneic Transplantation From Related Haploidentical Donors

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Not accepted

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).

Detailed description

An alternative to conventional allogeneic bone marrow transplantation is by using a non-myeloablative conditioning regimen. This regime would consist of both; total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG). Used in combination 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. The expected results of this transplant regime will be expected to result in hematopoietic and immunologic reconstitution, decreased deaths related to the treatment regimen and decreased gravft-vs-host disease (GVHD).

Conditions

• Blood Cancer
• Leukemia
• Graft Versus Host Disease
• Malignancy
• CLL
• NHL
• Hodgkin's Disease
• MDS

Interventions

Type	Name	Description
PROCEDURE	non-myeloablative hematopoietic cell transplantation	TLI and ATG infusion of the donor graft Post-transplant immunosuppression with cyclosporine and mycophenolate mofetil.
DRUG	Anti-Thymocyte Globulin	1.5 mg/kg QD x 5, IV. Dosage will be based on body weight. Purified, sterile IgG fraction of immune serum of rabbits immumixied with human thymus lymphocyte. This drug acts to modify the number and function of lymphocytes.
DRUG	Cyclosporine	6.25 mg/kg BID, PO.Mechanism of action is inhibition of T-cell activation by binding to a cytoplasmic protein (cyclophillin).
DRUG	Mycophenolate Mofetil	15 mg/kg Q 8 hours, PO. Inhibtis the enzme inosine monophsophate dehydrogenase (MPDII) noncompetitively which blocks the de nobo synthesis of guanosine required for DNA synthesis and has an effect on T and B cells.
DRUG	G-CSF	16 mg/kg, SQ Growth factor used to make bone marrow produce more blood cells
DRUG	Solumedrol	1.0 mg/kg IV 2 hours prior to ATG Used to treat severe inflamation
DRUG	Acetaminophen	650 mg PO, 30 minutes prior to infusion Pain reliever
DRUG	Diphenydramine	50 mg IV, 30 minutes prior to infusion Used to relieve allergy symptoms
DRUG	Hydrocortisone	100 mg IV, 1 hour prior to infusion Used to relieve itching, redness and swelling of the skin

Timeline

• Start date: 2000-08-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2005-09-16
• Last updated: 2019-12-04
• Results posted: 2017-01-26

Locations

1 site across 1 country: United States