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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Dec 23, 2012

Keywords

ClinConnect Summary

This clinical trial aims to explore the effects of a combined bone marrow and kidney transplant for patients with chronic kidney disease and certain blood disorders, such as leukemia and lymphoma. The study will involve about 10 participants who have both a kidney issue and a blood disorder that could be treated with a bone marrow transplant. One of the benefits of this approach is that the kidney and bone marrow will come from the same donor, which may reduce the chances of the kidney being rejected and lessen the need for long-term medications to prevent rejection.

To be eligible for this trial, participants should be between 18 and 70 years old and should have a specific blood disorder that can be treated with a bone marrow transplant. They also need to have a close relative who can donate both kidney and bone marrow. Participants can expect to undergo a less intense treatment process compared to traditional methods, which is designed to minimize side effects. This trial is a unique opportunity for patients looking for new ways to manage their conditions while potentially reducing long-term medication use.

Gender

ALL

Eligibility criteria

• 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