Combined bone marrow and kidney transplant for patients with blood disorders and kidney disease
Combined Haploidentical Reduced Intensity Bone Marrow and Kidney Transplantation for Patients With Chronic Kidney Disease and Advanced Hematological Disorders
This study is testing whether a combined bone marrow and kidney transplant from a close relative can help people with blood disorders and kidney disease while reducing the need for strong medications and minimizing risks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT01758042 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the outcomes of a combined bone marrow and kidney transplant from a haploidentical donor in patients suffering from chronic kidney disease and various blood disorders. The study will involve approximately 10 participants, focusing on the potential benefits of reduced kidney rejection and decreased need for long-term anti-rejection medications due to the donor being a close relative. Traditional chemotherapy and radiation therapies, which carry significant risks, will be minimized in this approach. Participants will be closely monitored for their response to the dual transplant.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with a hematological disorder that can be treated with bone marrow transplantation and who have a haploidentical first-degree relative willing to donate.
Not a fit: Patients with conditions not amenable to bone marrow transplantation or those without a suitable haploidentical donor may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option that addresses both kidney disease and blood disorders simultaneously, improving patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies involving haploidentical transplants have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Yi-Bin A Chen, M.D. — Director of Clinical Research, Massachusetts General Hospital Bone Marrow Transplant Program
- Study coordinator: Yi-Bin A Chen, M.D.
- Email: ychen6@partners.org
- Phone: 617-724-1124
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.