RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Combined Haploidentical Reduced Intensity Bone Marrow and Kidney Transplantation for Patients With Chronic Kidney Disease and Advanced Hematological Disorders

Quick Facts

Study Start:2012-11
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01758042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients ages 18-70
  2. * 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.
  3. * Existence of haploidentical first degree relative who passes standard donor evaluations for bone marrow and kidney donation
  4. * LVEF \> 40% as measured by echocardiography or MUGA
  5. * FEV1, FVC, and DLCO \> 50% of predicted as measured by standard PFTs
  6. * 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
  7. * ABO compatibility in the host vs. graft direction
  8. * 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.
  9. * Participants should be on dialysis or have an estimated or measured CrCl \< 35 ml/min
  10. * Life expectancy greater than six months.
  11. * Recipient ability to understand and provide informed consent
  1. * Active serious infection
  2. * Participation in other investigational drug use at the time of enrollment
  3. * Contraindication to therapy with any one of the proposed agents (e.g., history of allergy to rabbit serum in ATG)
  4. * Serologic positivity for HIV, HCV, or HbsAg positivity
  5. * ABO blood group incompatibility in the host-vs-graft direction
  6. * Active serious infection

Contacts and Locations

Study Contact

Yi-Bin A Chen, M.D.
CONTACT
617-724-1124
ychen6@partners.org
Candice Del Rio, RN
CONTACT
617-726-6034
cdelrio@partners.org

Principal Investigator

Yi-Bin A Chen, M.D.
PRINCIPAL_INVESTIGATOR
Director of Clinical Research, Massachusetts General Hospital Bone Marrow Transplant Program

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Yi-Bin A Chen, M.D., PRINCIPAL_INVESTIGATOR, Director of Clinical Research, Massachusetts General Hospital Bone Marrow Transplant Program

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-11
Study Completion Date2027-07

Study Record Updates

Study Start Date2012-11
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • Kidney
  • Chronic Kidney Disease
  • CKD
  • Bone Marrow
  • Bone Marrow Transplant
  • BMT
  • Leukemia
  • AML
  • ALL
  • CML
  • CLL
  • MM
  • NHL
  • MDS

Additional Relevant MeSH Terms

  • 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