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


N/A
18 Years
70 Years
Open (Enrolling)
Both
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

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients who die of treatment-related complications.

Outcome Description:

Assess safety of haploidentical combined bone marrow and kidney transplantation as measured treatment related mortality.

Outcome Time Frame:

100 days and 1 year post transplant

Safety Issue:

Yes

Principal Investigator

Yi-Bin A Chen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Director of Clinical Research, Massachusetts General Hospital Bone Marrow Transplant Program

Authority:

United States: Data and Safety Monitoring Board

Study ID:

2012P001355

NCT ID:

NCT01758042

Start Date:

November 2012

Completion Date:

January 2015

Related Keywords:

  • 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
  • Kidney
  • Chronic Kidney Disease
  • CKD
  • Bone Marrow
  • Bone Marrow Transplant
  • BMT
  • Leukemia
  • AML
  • ALL
  • CML
  • CLL
  • MM
  • NHL
  • MDS
  • Primary Myelofibrosis
  • Amyloidosis
  • Anemia
  • Anemia, Aplastic
  • Anemia, Sickle Cell
  • Autoimmune Diseases
  • Hematologic Diseases
  • Hodgkin Disease
  • Kidney Diseases
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Thalassemia
  • Anemia, Diamond-Blackfan
  • Renal Insufficiency, Chronic
  • Kidney Failure, Chronic

Name

Location

Massachusetts General Hospital Boston, Massachusetts  02114-2617