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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01758042
Recruitment Status : Recruiting
First Posted : December 31, 2012
Last Update Posted : March 15, 2023
Sponsor:
Information provided by (Responsible Party):
Yi-Bin A. Chen, MD, Massachusetts General Hospital

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
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 Procedure: Haploidentical Bone Marrow/Kidney Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Haploidentical Reduced Intensity Bone Marrow and Kidney Transplantation for Patients With Chronic Kidney Disease and Advanced Hematological Disorders
Study Start Date : November 2012
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Haploidentical Bone Marrow/Kidney
Single Arm Study
 Procedure: Haploidentical Bone Marrow/Kidney
Combined bone marrow and kidney transplantation using a haploidentical donor.


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients who die of treatment-related complications. [ Time Frame: 100 days and 1 year post transplant ]
    Assess safety of haploidentical combined bone marrow and kidney transplantation as measured treatment related mortality.


Secondary Outcome Measures :
  1. Number of patients with acute and delayed renal allograft rejection [ Time Frame: 2 years post-transplant ]

Other Outcome Measures:
  1. Number of patients who are able to discontinue immunosuppressive therapy by one year post transplant [ Time Frame: one year post transplant ]
  2. Number of patients who develop acute and chronic graft versus host disease (GVHD). [ Time Frame: post transplant ]
  3. Number of patients who relapse from their underlying hematological disease [ Time Frame: 6 months, 1 year, and 2 years post transplant. ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758042


Contacts
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Contact: Yi-Bin A Chen, M.D. 617-724-1124 ext 2 ychen6@partners.org
Contact: Candice Del Rio, RN 617-726-6034 cdelrio@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Yi-Bin A Chen, M.D.    617-724-1124 ext 2    ychen6@partners.org   
Contact: Candice Delrio, RN    617-726-6034    cdelrio@partners.org   
Principal Investigator: Yi-Bin Chen, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Yi-Bin A Chen, M.D. Director of Clinical Research, Massachusetts General Hospital Bone Marrow Transplant Program
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yi-Bin A. Chen, MD, Director of Clinical Research, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01758042    
Other Study ID Numbers: 2012P001355
First Posted: December 31, 2012    Key Record Dates
Last Update Posted: March 15, 2023
Last Verified: March 2023
Keywords provided by Yi-Bin A. Chen, MD, Massachusetts General Hospital:
Kidney
Chronic Kidney Disease
CKD
Bone Marrow
Bone Marrow Transplant
BMT
Leukemia
 AML
ALL
CML
CLL
MM
NHL
MDS
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid, Acute
Multiple Myeloma
Lymphoma, Non-Hodgkin
Preleukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Hodgkin Disease
Immunoglobulin Light-chain Amyloidosis
Kidney Diseases
Renal Insufficiency, Chronic
Anemia
Myelodysplastic Syndromes
 Thalassemia
Anemia, Aplastic
Anemia, Sickle Cell
Myeloproliferative Disorders
Anemia, Diamond-Blackfan
Amyloidosis
Autoimmune Diseases
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders