Combined Haploidentical Reduced Intensity Bone Marrow and Kidney Transplantation for Patients With Chronic Kidney Disease and Advanced Hematological Disorders

Description

The main purpose of this study is to examine the outcome of a combined bone marrow and kidney transplant from a partially matched related (haploidentical or "haplo") donor. This is a pilot study, you are being asked to participate because you have a blood disorder and kidney disease. The aim of the combined transplant is to treat both your underlying blood disorder and kidney disease. We expect to have about 10 people participate in this study. Additionally, because the same person who is donating the kidney will also be donating the bone marrow, there may be a smaller chance of kidney rejection and less need for long-term use of anti-rejection drugs. Traditionally, very strong cancer treatment drugs (chemotherapy) and radiation are used to prepare a subject's body for bone marrow transplant. This is associated with a high risk for serious complications, even in subjects without kidney disease. This therapy can be toxic to the liver, lungs, mucous membranes, and intestines. Additiona

Trial Eligibility

Inclusion Criteria: * Patients ages 18-70 * Underlying hematological disorder which is potentially curable with allogeneic bone marrow transplantation. This includes, but is not limited to: acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML), chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), Hodgkin lymphoma, multiple myeloma (MM), myelodysplastic syndrome (MDS), AL amyloidosis, diamond blackfan anemia, myelofibrosis or other myeloproliferative disease, sickle cell anemia, and thalassemia. * Existence of haploidentical first degree relative who passes standard donor evaluations for bone marrow and kidney donation * LVEF \> 40% as measured by echocardiography or MUGA * FEV1, FVC, and DLCO \> 50% of predicted as measured by standard PFTs * Total bilirubin \< 2.0 (unless diagnosis of Gilbert's or hemolysis is made) and AST, ALT, alkaline phosphatase all \< 5x institutions upper limit of normal * ABO compatibility in the host vs. graft direction * Men and women of reproductive potential must agree to use a reliable method of birth control during the treatment, and women should do so for a period of 1 year following the transplant. * Participants should be on dialysis or have an estimated or measured CrCl \< 35 ml/min * Life expectancy greater than six months. * Recipient ability to understand and provide informed consent Exclusion Criteria: * Active serious infection * Participation in other investigational drug use at the time of enrollment * Contraindication to therapy with any one of the proposed agents (e.g., history of allergy to rabbit serum in ATG) * Serologic positivity for HIV, HCV, or HbsAg positivity * ABO blood group incompatibility in the host-vs-graft direction * Active serious infection

Study Info

Interventions

Locations Recruiting

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