Skip to content

Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01758042
Acronym
BMT
Enrollment
10
Registered
2012-12-31
Start date
2012-11-01
Completion date
2025-07-01
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), AL Amyloidosis, Aplastic Anemia, Autoimmune Diseases, Chronic Kidney Disease, Chronic Lymphocytic Leukemia (CLL), Chronic Myelogenous Leukemia (CML), Diamond Blackfan Anemia, Hodgkin Disease, Multiple Myeloma, Myelodysplastic Syndrome (MDS), Myelofibrosis, Myeloproliferative Disease, Non-Hodgkin's Lymphoma (NHL), Sickle Cell Anemia, Thalassemia

Keywords

Kidney, Chronic Kidney Disease, CKD, Bone Marrow, Bone Marrow Transplant, BMT, Leukemia, AML, ALL, CML, CLL, MM, NHL, MDS

Brief 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.

Interventions

PROCEDUREHaploidentical Bone Marrow/Kidney

Combined bone marrow and kidney transplantation using a haploidentical donor.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients who die of treatment-related complications.100 days and 1 year post transplantAssess safety of haploidentical combined bone marrow and kidney transplantation as measured treatment related mortality.

Secondary

MeasureTime frame
Number of patients with acute and delayed renal allograft rejection2 years post-transplant

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORYi-Bin A Chen, M.D.

Director of Clinical Research, Massachusetts General Hospital Bone Marrow Transplant Program

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026