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

Study point of contact

Candice Del Rio, RN
617-726-6034
[email protected]
Yi-Bin A Chen, M.D.
617-724-1124 ext 2
[email protected]

Locations

1 United States site

Age

18 to 70 Years

Phase

N/A

Study type

Interventional

Gender

All

Interventions

Procedure

Compensation

Unknown

About the study

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.

participation requirements

– 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

participation restrictions

– 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

Locations

  • Boston, Massachusetts, United States, Massachusetts General Hospital, 02114 [Recruiting]
Last updated 2017-03-21 Enroll Now