Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders
NCT ID: NCT01758042
Last Updated: 2023-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2012-11-30
2027-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Haploidentical Bone Marrow/Kidney
Single Arm Study
Haploidentical Bone Marrow/Kidney
Combined bone marrow and kidney transplantation using a haploidentical donor.
Interventions
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Haploidentical Bone Marrow/Kidney
Combined bone marrow and kidney transplantation using a haploidentical donor.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Yi-Bin A. Chen, MD
Director of Clinical Research
Principal Investigators
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Yi-Bin A Chen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Director of Clinical Research, Massachusetts General Hospital Bone Marrow Transplant Program
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Chen YB, Elias N, Heher E, McCune JS, Collier K, Li S, Del Rio C, El-Jawahri A, Williams W, Tolkoff-Rubin N, Fishman JA, McAfee S, Dey BR, DeFilipp Z, O'Donnell PV, Cosimi AB, Sachs D, Kawai T, Spitzer TR. Haploidentical hematopoietic cell and kidney transplantation for hematological malignancies and end-stage renal failure. Blood. 2019 Jul 11;134(2):211-215. doi: 10.1182/blood.2019000775. Epub 2019 May 31.
Other Identifiers
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2012P001355
Identifier Type: -
Identifier Source: org_study_id
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