One donor, two transplants: could this end lifelong Anti-Rejection drugs?
NCT ID NCT01758042
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tested a combined bone marrow and kidney transplant from a partially matched family donor in 10 people with both a blood disorder and chronic kidney disease. The goal was to treat both conditions at once and possibly reduce the need for lifelong anti-rejection drugs. Participants received a milder chemotherapy and radiation regimen to lower side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Combined bone marrow and kidney transplant from a partially matched related donor
- What this could lead to
- If successful, this approach could reduce the need for lifelong anti-rejection drugs after kidney transplant and treat both the blood disorder and kidney disease in one procedure.
- What could go wrong
- This is a very small pilot study with only 10 participants, so results may not apply broadly. The procedure carries serious risks including infection, graft-versus-host disease, and treatment-related death.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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10 people
The number who actually took part.
- Started
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Nov 2012
- Finished
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Jul 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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