Allogeneic Transplantation From Related Haploidentical Donors
|Blood Cancer Leukemia Graft Versus Host Disease Malignancy CLL NHL Hodgkin's Disease MDS||Procedure: non-myeloablative hematopoietic cell transplantation Drug: Anti-Thymocyte Globulin Drug: Cyclosporine Drug: Mycophenolate Mofetil Drug: G-CSF Drug: Solumedrol Drug: Acetaminophen Drug: Diphenydramine Drug: Hydrocortisone||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Engraftment of Haploidentical CD34+ Selected Blood Stem Cells in Older Patients or Those With Medical Co-morbidities Following Total Lymphoid Irradiation and Antithymocyte Globulin Transplant Conditioning [ Time Frame: 100 days ]number achieving donor cell engraftment (>95%) by day 90 after transplant.
- Acute Graft-versus-Host Disease (GVHD) Grade 2-4 Risk From Time of Transplant Until Day 90 Post-transplant [ Time Frame: 90 days ]GVHD grading system goes from 0-4 where grade 4 is the most severe. Grade 0 and 1 do not require systemic treatment, Grade 2-4 require treatment. This trial evaluated the risk of developing acute GVHD grades 2-4 within 90 days of transplant.
|Study Start Date:||August 2000|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Experimental: Transplantation of CD34+ cells
Week #1: Total Lymphoid Inrradiation (TLI) 120 cGy + Anti-thymocyte Globulin (ATG) 1.5 mg/kg + Solumedrol 1.0 mg/kg Daily for 5 days.
Week #2: TLI 120 cGy (3 days a week, double on the 4th day) 5 days of CSP (oraly) one day after TLI was started. 3 days of MMF 4 days after TLI was started.
Procedure: non-myeloablative hematopoietic cell transplantation
TLI and ATG infusion of the donor graft Post-transplant immunosuppression with cyclosporine and mycophenolate mofetil.
Other Name: Peripheral-blood stem-cell transplantationDrug: 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.
Other Name: ATGDrug: Cyclosporine
6.25 mg/kg BID, PO.Mechanism of action is inhibition of T-cell activation by binding to a cytoplasmic protein (cyclophillin).
Other Names: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.
Other Names:Drug: G-CSF
16 mg/kg, SQ Growth factor used to make bone marrow produce more blood cells
Other Names:Drug: Solumedrol
1.0 mg/kg IV 2 hours prior to ATG Used to treat severe inflamation
Other Names:Drug: Acetaminophen
650 mg PO, 30 minutes prior to infusion Pain reliever
Other Name: TylenolDrug: Diphenydramine
50 mg IV, 30 minutes prior to infusion Used to relieve allergy symptoms
Other Names:Drug: Hydrocortisone
100 mg IV, 1 hour prior to infusion Used to relieve itching, redness and swelling of the skin
Other Name: Hydrocortisone Sodium Phosphate
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185692
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Robert Lowsky||Stanford University|