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

Clinical Trial: NCT00074490

Donor Stem Cell Transplant With No or Low-Intensity Chemotherapy Using Sirolimus and Treated Immune Cells to Treat Blood and Lymph Cancers
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)