Modified Stem Cell Transplant Procedure to Treat Patients With Blood and Immune System Cancers

Study Summary

This study will investigate the safety and effectiveness of a modified stem cell transplant procedure for treating cancers of the blood and immune system. Patients with cancers and pre-cancerous conditions originating in blood or immune system cells can sometimes benefit greatly from, and even be cured by, transplants of stem cells (cells produced by the bone marrow that mature into blood cells). In addition to producing new bone marrow and restoring normal blood production and immunity, the donated cells fight any residual tumor cells that might have remained in the body, in what is called a graft-versus-tumor effect. However, severe problems, and sometimes death, may follow these transplants as a result of the high-dose chemotherapy and radiation that accompany the procedure. Also, donated immune system cells called T cells sometimes attack healthy tissues in a reaction called graft-versus-host-disease (GVHD), damaging organs such as the liver, intestines and skin. This study will use the following strategies to try to reduce these risks: * induction chemotherapy to reduce patient's immunity in an attempt to prevent rejection of the donated stem cells; * reduced-intensity conditioning chemotherapy that is easier for the body to tolerate and involves a shorter period of complete immune suppression; * donation of immune cells called T helper type 2 (Th2) cells instead of T cells to try to reduce the risk of serious GVHD; * treatment with methotrexate and cyclosporine to try to reduce the risk of serious GVHD. Patients between 12 and 75 years of age with non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma, chronic lymphocytic leukemia, chronic myelogenous leukemia, acute myelogenous leukemia, acute lymphocytic leukemia, myelodysplasia, idiopathic myelofibrosis, polycythemia vera, or chronic myelomonocytic leukemia may be eligible for this study. Candidates will have a medical history, physical and dental examinations, blood and urine tests (including a bl

Primary Outcome

Here is the number of recipients who developed grades I-IV acute graft versus host disease (GVHD) following a combination of cyclosporine and a mini-dose methotrexate regimen for graft-versus-host disease (GVHD) prophylaxis. Grades I-IV acute GVHD clinical staging was assessed by the Glucksberg Criteria. Grade I-IV acute GVHD can occur in the skin, liver, and/or gut. Grade 1: rash \< 25% body surface area (BSA), total bilirubin 2-3 mg/dl, and diarrhea 500-1000 ml/d. Grade 2: 25-50% BSA, total bi

Interventions

• DRUG Cyclophosphamide
• DRUG Fludarabine
• DRUG Doxorubicin
• DRUG Etoposide
• PROCEDURE Stem cell transplantation