Methods to Enhance the Safety and Effectiveness of Stem Cell Transplants
|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: NCT00378534|
Recruitment Status : Completed
First Posted : September 20, 2006
Results First Posted : January 6, 2015
Last Update Posted : October 28, 2015
Bone marrow stem cell transplants (otherwise called bone marrow transplants) from healthy donors are sometimes the only means of curing hematological malignant diseases such as acute and chronic leukemias, myelodysplastic syndrome, myeloproliferative diseases and lymphomas. Before transplant the patient receives chemotherapy and radiation treatment to reduce the malignancy to low levels and to prevent rejection of the transplant. The transplant restores the blood counts to normal and replaces the patients immunity with that of the donor. The donor's immune cells increase the effect of the transplant by attacking remaining malignant cells. Donor immune cells (especially those called T lymphocytes) also attack healthy non-cancerous cells and tissues of the recipient causing "graft-versus-host-disease" (GVHD). Strong GVHD reactions occurring within weeks after the transplant can be life-threatening . In this study we remove most of the T lymphocytes from the transplant to minimize the risk of GVHD. However to improve immunity against residual malignant cells and boost immunity to infections, donor T cells (stored frozen at time of transplant) are given back around 90 days after the transplant when they have a reduced risk of causing serious GVHD.
Any patient between 10 and 75 years of age with acute or chronic leukemia, myelodysplastic syndrome, myeloproliferative syndromes or lymphoma, who have a family member who is a suitable stem cell donor may be eligible for this study. Candidates are screened with a medical history and various tests and examinations.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myelogenous Leukemia Acute Myelogenous Leukemia Chronic Lymphocytic Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome||Device: Miltenyi reagent system Drug: Fludarabine Drug: Cyclosporine Drug: Cyclophosphamide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Peripheral Blood Stem Cell Allotransplantation for Hematological Malignancies Using a Positive Stem Cell Selection Technique for T Cell Depletion, Followed by Delayed T Cell Add-Back|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Experimental: Miltenyi reagent system
The protocol will evaluate survival at day +200 in subjects with hematological malignancies receiving myeloablative conditioning regimen of cyclophosphamidem fludarabine and total body irradiation followed by an infusion of a stem cell prodict prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infusion (DLI) at day 90.
The objective is to determine the overall survival rate at day +200 following allogeneic peripheral blood stem cell allotransplantation (PBSCT)
Device: Miltenyi reagent system
Miltenyi Clinimax CD34 Reagent System for CD34 selectioni and delayed T cell depletion add back
Other Name: Miltenyi Clinimax CD34 Reagent System
Other Name: Fludara
Other Name: Neoral
Other Name: Cytoxan
- Survival and Non-relapse Mortality at Day +200 Using the Miltenyi Reagent System [ Time Frame: Day 200 ]Subjects with hematological malignancies receiving a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infucion at day 90. The subjects receiveing allogeneic stem cell transplantation will have stem cell product prepared using Miltenyi CliniMacs system to determine the overall survival and non-relapse mortality at day +200.
- Standard Transplant Outcome Variables Such as Non-hematologic Toxicity, Incidence and Severity of Acute and Chronic GVHD and Relapse of Disease. [ Time Frame: 3 years maximum ]
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): NCT00378534
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Minocher M Battiwalla, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|