Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Blood Cancer, Infectious Disease, Lymphoma, Anemia, Hematology |
| Therapuetic Areas: | Hematology, Immunology / Infectious Diseases, Nephrology / Urology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 3/23/2017 |
| Start Date: | November 2012 |
| End Date: | July 2021 |
| Contact: | Yi-Bin A Chen, M.D. |
| Email: | ychen6@partners.org |
| Phone: | 617-724-1124 |
Combined Haploidentical Reduced Intensity Bone Marrow and Kidney Transplantation for Patients With Chronic Kidney Disease and Advanced Hematological Disorders
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.
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.
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
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Yi-Bin Chen, MD
Phone: 617-724-1124
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