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Clinical Trial Summary

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. Additionally, it is believed that standard therapy may be associated with a higher risk of a complication called graft versus host disease (GVHD) where the new donor cells attack the recipient's normal body. Recently, less intense chemotherapy and radiation regimens have been employed (these are called reduced intensity regimens) which cause less injury and GVHD to patients, and thus, have allowed older and less healthy patients to undergo bone marrow transplant. In this study, a reduced intensity regimen of chemotherapy and radiation will be used with the intent of producing fewer toxicities than standard therapy. Typical therapy following a standard kidney transplant includes multiple lifelong medications that aim to prevent the recipient's body from attacking or rejecting the donated kidney. These are called immunosuppressant drugs and they work by "quieting" the recipient's immune system to allow the donated kidney to function properly. One goal in our study is to decrease the duration you will need to be on immunosuppressant drugs following your kidney transplant as the bone marrow transplant will provide you with the donor's immune system which should not attack the donor kidney.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Acute Lymphoblastic Leukemia (ALL)
  • Acute Myeloid Leukemia (AML)
  • AL Amyloidosis
  • Amyloidosis
  • Anemia
  • Anemia, Aplastic
  • Anemia, Diamond-Blackfan
  • Anemia, Sickle Cell
  • Aplastic Anemia
  • Autoimmune Diseases
  • Chronic Kidney Disease
  • Chronic Lymphocytic Leukemia (CLL)
  • Chronic Myelogenous Leukemia (CML)
  • Diamond Blackfan Anemia
  • Hodgkin Disease
  • Immunoglobulin Light-chain Amyloidosis
  • Kidney Diseases
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Myelodysplastic Syndrome (MDS)
  • Myelodysplastic Syndromes
  • Myelofibrosis
  • Myeloproliferative Disease
  • Myeloproliferative Disorders
  • Non-Hodgkin's Lymphoma (NHL)
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Preleukemia
  • Renal Insufficiency, Chronic
  • Sickle Cell Anemia
  • Thalassemia

NCT number NCT01758042
Study type Interventional
Source Massachusetts General Hospital
Contact Yi-Bin A Chen, M.D.
Phone 617-724-1124
Email ychen6@partners.org
Status Recruiting
Phase N/A
Start date November 2012
Completion date July 2027

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