Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 70 Years|
- - Patients ages 18-70.
- - Underlying hematological disorder which is potentially curable with allogeneic bone marrow transplantation.
- - 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.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Massachusetts General Hospital|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Yi-Bin A Chen, M.D.|
|Principal Investigator Affiliation||Director of Clinical Research, Massachusetts General Hospital Bone Marrow Transplant Program|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Chronic Kidney Disease, Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Chronic Myelogenous Leukemia (CML), Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL), Hodgkin Disease, Multiple Myeloma, Myelodysplastic Syndrome (MDS), Aplastic Anemia, AL Amyloidosis, Diamond Blackfan Anemia, Myelofibrosis, Myeloproliferative Disease, Sickle Cell Anemia, Autoimmune Diseases, Thalassemia|
Other: Haploidentical Bone Marrow/Kidney
Single Arm Study
Procedure: - Haploidentical Bone Marrow/Kidney
Combined bone marrow and kidney transplantation using a haploidentical donor.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.