Donor Stem Cell Transplant With No or Low-Intensity Chemotherapy Using Sirolimus and Treated Immune Cells to Treat Blood and Lymph Cancers | Aplastic Anemia & MDS International Foundation
Donor Stem Cell Transplant With No or Low-Intensity Chemotherapy Using Sirolimus and Treated Immune Cells to Treat Blood and Lymph Cancers

Clinical Trial: NCT00074490

For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

Background:

Patients with cancers of the blood and immune system often benefit from transplants of stem cells from a genetically well-matched sibling. However, severe problems may follow these transplants because of the high-dose chemotherapy and radiation that accompany the procedure. Also, donated immune cells sometimes attack healthy tissues in a reaction called graft-versus-host disease (GVHD), damaging organs such as the liver, intestines and skin. To reduce toxicity of high-dose preparative chemotherapy, this study performs allogeneic transplant after low doses of chemotherapy. In an attempt to improve anti-tumor effects without increasing GVHD, this study uses donor immune cells (Th2 cells) grown in the laboratory; some patients will receive standard donor immune cells (not grown in laboratory). All patients will receive immune modulating drugs sirolimus and cyclosporine to prevent GVHD.

Objective:

To determine the safety, treatment effects and rate of GVHD in patients receiving transplants that use low-intensity chemotherapy, sirolimus plus cyclosporine, and transplant booster with either Th2 cells or standard immune cells.

Status: 
Recruiting
Study Date: 
Mon, 12/01/2003 to Wed, 12/01/2021
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Drug: Rituximab Rituximab:375 mg/m2/day IV, day 1 (for CD20+ patients) Drug: Fludarabine Fludarabine:25 mg/m2/day IV, days 1-4 Drug: Cyclosporine Cyclosporine:2 mg/kg/dose every 12 hours on day +7 Drug: Etoposide Etoposide: 50 mg/m2/day CIV, days 1-4 Drug: Doxorubicin Doxorubicin:10 mg/m2/day CIV, days 1-4 Drug: Vincristine Vincristine:0.4 mg/m2/day CIV, days 1-4 Drug: Cyclophosphamide Cyclophosphamide, 750 mg/m2/day IV, day 5 Biological: T-Rapa cell DLI The dose of Th2 cells or unmanipulated donor T cells will attempt to be held constant for each study recipient (target dose 2.5 x 107 Th2/kg; minimum dose will be 1 x 107 Th2/kg). Procedure: T cell DLI Th2 Cell Transplantation Drug: Prednisone Prednisone:60 mg/m2/day PO, days 1-5 Procedure: Allogeneic HSCT Allogeneic Hematopoietic Stem Cell Transplant Drug: Filgrastim Filgrastim:5 mcg/kg/day SC, day 6 (require ANC & gt; 1000, two values; or ANC & gt; 5000 cells/ul on one occasion)