Allogeneic Transplantation From Related Haploidentical Donors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00185692|
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : January 26, 2017
Last Update Posted : December 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||August 2000|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
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 transplantation
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.
Other Name: ATG
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.
16 mg/kg, SQ Growth factor used to make bone marrow produce more blood cells
1.0 mg/kg IV 2 hours prior to ATG Used to treat severe inflamation
650 mg PO, 30 minutes prior to infusion Pain reliever
Other Name: Tylenol
50 mg IV, 30 minutes prior to infusion Used to relieve allergy symptoms
100 mg IV, 1 hour prior to infusion Used to relieve itching, redness and swelling of the skin
Other Name: Hydrocortisone Sodium Phosphate
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185692
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Robert Lowsky||Stanford University|