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Completed Phase 1Phase 2 Interventional Accepts healthy volunteers Results available

Reduced Intensity, Partially HLA Mismatched BMT to Treat Hematologic Malignancies

NCT01203722
Conditions
Hematologic Malignancies
Interventions
Fludarabine, Cytoxan, Total Body Irradiation, Allogeneic Blood or Marrow Transplant, Peripheral Blood Stem Cell Transplant, Mycophenolate Mofetil, Sirolimus, Tacrolimus
Drug · Radiation · Procedure
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Other
Eligibility
6 Months to 75 Years
Enrollment
87 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2010 – 2024
U.S. locations
1
States / cities
Baltimore, Maryland
Conditions
Crohn's Disease
Interventions
Fludarabine, Cyclophosphamide, Mesna, Alemtuzumab, G-CSF, Rifaximin, Tacrolimus
Drug
Lead sponsor
Northwestern University
Other
Eligibility
18 Years to 49 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2024
U.S. locations
1
States / cities
Chicago, Illinois
Conditions
Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Precancerous/Nonmalignant Condition, Small Intestine Cancer
Interventions
anti-thymocyte globulin, filgrastim, cladribine, cyclophosphamide, etoposide, methylprednisolone, tacrolimus, allogeneic bone marrow transplantation, in vitro-treated peripheral blood stem cell transplantation
Biological · Drug · Procedure
Lead sponsor
Northwestern University
Other
Eligibility
Up to 45 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
1999 – 2000
U.S. locations
1
States / cities
Chicago, Illinois
Conditions
Kidney Transplantation, Renal Transplantation, Grafting, Kidney
Interventions
Envarsus XR, Tacrolimus
Drug
Lead sponsor
University of California, Los Angeles
Other
Eligibility
13 Years to 20 Years
Enrollment
28 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2023
U.S. locations
1
States / cities
Los Angeles, California
Conditions
Hematologic Malignancies
Interventions
L-leucyl-L-leucine Methyl Ester (LLME), Fludarabine, Cytarabine, Cyclophosphamide, Tacrolimus, Mesna, Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF), Hematopoietic stem cell transplantation (HSCT)
Drug · Biological · Procedure
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Other
Eligibility
18 Years and older
Enrollment
14 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2009
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Conditions
Type 1 Diabetes Mellitus
Interventions
Allogeneic Pancreatic Islet Cells, Sirolimus, Basiliximab, Tacrolimus, Antibacterial, Antifungal, and Antiviral Prophylaxis, Trimethoprim/sulfamethoxazole, Clotrimazole, Valganciclovir, Heparin, Enoxaparin, Pentoxifylline, Aspirin
Biological · Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
Not listed
Healthy volunteers
Healthy volunteers not accepted
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Conditions
Kidney Failure, Renal Failure
Interventions
Tacrolimus (Tacro™), Prograf
Drug
Lead sponsor
Veloxis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
63 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
1
States / cities
Cincinnati, Ohio
Conditions
Kidney Transplantation, Renal Transplantation
Interventions
Alemtuzumab, MMF, Basiliximab, Short-term Tac, tacrolimus, Belatacept, methylprednisolone
Drug · Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 65 Years
Enrollment
19 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2015
U.S. locations
3
States / cities
Birmingham, Alabama • San Francisco, California • Atlanta, Georgia
Conditions
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia, Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia in Remission, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, DS Stage II Plasma Cell Myeloma, DS Stage III Plasma Cell Myeloma, High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, ISS Stage II Plasma Cell Myeloma, ISS Stage III Plasma Cell Myeloma, Myelodysplastic Syndrome, Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent Chronic Lymphocytic Leukemia, Recurrent Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Acute Lymphoblastic Leukemia, Refractory Chronic Lymphocytic Leukemia, Refractory Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Refractory Small Lymphocytic Lymphoma, Secondary Acute Myeloid Leukemia, Therapy-Related Acute Myeloid Leukemia, Therapy-Related Myelodysplastic Syndrome
Interventions
Allogeneic Hematopoietic Stem Cell Transplantation, Cyclophosphamide, Fludarabine Phosphate, Laboratory Biomarker Analysis, Lenalidomide, Melphalan, Mycophenolate Mofetil, Natural Killer Cell Therapy, Rituximab, Tacrolimus, Total-Body Irradiation, Umbilical Cord Blood Transplantation
Procedure · Drug · Other + 2 more
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
Up to 75 Years
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2021
U.S. locations
1
States / cities
Houston, Texas
Conditions
Myeloproliferative Disorders, Kidney Cancer, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
Interventions
anti-thymocyte globulin, busulfan, cyclophosphamide, fludarabine phosphate, methotrexate, tacrolimus, nonmyeloablative allogeneic HSCT
Biological · Drug · Procedure
Lead sponsor
Northside Hospital, Inc.
Other
Eligibility
Up to 75 Years
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2012
U.S. locations
1
States / cities
Atlanta, Georgia
Conditions
Renal Transplantation
Interventions
Enteric-coated mycophenolate sodium (EC-MPS), Mycophenolate mofetil, Placebo to mycophenolate sodium, Placebo to mycophenolate mofetil
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 75 Years
Enrollment
400 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2006
U.S. locations
53
States / cities
Phoenix, Arizona • Los Angeles, California • Sacramento, California + 40 more
Conditions
Primary Membranous Nephropathy
Interventions
Zanubrutinib, Tacrolimus
Drug
Lead sponsor
BeOne Medicines
Industry
Eligibility
18 Years to 75 Years
Enrollment
178 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
4
States / cities
Granada Hills, California • Palo Alto, California • Minneapolis, Minnesota + 1 more
Conditions
Sickle Cell Disease, Sickle Cell Disorder, Hemoglobinopathies, Thalassemia, Anemia, Sickle Cell
Interventions
Cyclophosphamide, Pentostatin, Rabbit anti-thymocyte globulin, Tacrolimus, Mycophenolate mofetil, CD4+ T-cell-depleted Haploidentical Hematopoietic Transplant
Drug · Biological
Lead sponsor
City of Hope Medical Center
Other
Eligibility
18 Years to 45 Years
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2027
U.S. locations
1
States / cities
Duarte, California
Conditions
Kidney Transplantation
Interventions
anti-thymocyte globulin, Fludarabine, Cyclophosphamide, Total Body Irradiation, acetaminophen, diphenhydramine, methylprednisolone, bone marrow transplant, MESNA, mycophenolate mofetil, prednisone, filgrastim
Biological · Drug · Radiation
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 65 Years
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2017
U.S. locations
1
States / cities
Baltimore, Maryland
Conditions
Kidney Transplant Rejection, Medication Adherence
Interventions
Medication Event Monitoring System (MEMS), Once-Daily Tacrolimus extended release
Other · Drug
Lead sponsor
University of Colorado, Denver
Other
Eligibility
13 Years to 22 Years
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
1
States / cities
Aurora, Colorado
Conditions
Nephrotoxicity
Interventions
Belatacept
Drug
Lead sponsor
Indiana University
Other
Eligibility
18 Years to 65 Years
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
1
States / cities
Indianapolis, Indiana
Conditions
Hematopoietic and Lymphoid Cell Neoplasm, High Risk Acute Myeloid Leukemia, High Risk Myelodysplastic Syndrome, Lymphoproliferative Disorder, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasm, Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Recurrent High Risk Myelodysplastic Syndrome, Recurrent Hodgkin Lymphoma, Recurrent Myelodysplastic Syndrome, Recurrent Non-Hodgkin Lymphoma, Recurrent Plasma Cell Myeloma
Interventions
Allogeneic Hematopoietic Stem Cell Transplantation, Busulfan, Cyclophosphamide, Fludarabine, Fludarabine Phosphate, Laboratory Biomarker Analysis, Mycophenolate Mofetil, Pharmacological Study, Tacrolimus, Thiotepa
Procedure · Drug · Other
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
12 Years to 75 Years
Enrollment
204 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2028
U.S. locations
1
States / cities
Houston, Texas
Conditions
Acute Graft Versus Host Disease
Interventions
Tacrolimus (TAC), Methotrexate (MTX), Rapamycin (RAPA)
Drug
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
Other
Eligibility
16 Years to 70 Years
Enrollment
74 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2012
U.S. locations
1
States / cities
Tampa, Florida
Conditions
Use of Belatacept in Kidney Transplant Patients
Interventions
impact of administering one dose of belatacept on Estimated Glomerular Filtration Rate(eGFR)
Behavioral
Lead sponsor
Methodist Health System
Other
Eligibility
18 Years to 85 Years
Enrollment
67 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2025
U.S. locations
1
States / cities
Dallas, Texas
Conditions
B-Cell Prolymphocytic Leukemia, Hypodiploidy, Loss of Chromosome 17p, Plasma Cell Leukemia, Progression of Multiple Myeloma or Plasma Cell Leukemia, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Non-Hodgkin Lymphoma, Recurrent Childhood Hodgkin Lymphoma, Recurrent Childhood Non-Hodgkin Lymphoma, Recurrent Chronic Lymphocytic Leukemia, Recurrent Plasma Cell Myeloma, Recurrent Small Lymphocytic Lymphoma, Refractory Childhood Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Non-Hodgkin Lymphoma, Refractory Plasma Cell Myeloma, Refractory Small Lymphocytic Lymphoma, t(14;16), t(4;14), T-Cell Prolymphocytic Leukemia, Waldenstrom Macroglobulinemia
Interventions
Allogeneic Bone Marrow Transplantation, Allogeneic Hematopoietic Stem Cell Transplantation, Autologous Hematopoietic Stem Cell Transplantation, Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation, Carmustine, Cyclophosphamide, Cytarabine, Etoposide, Fludarabine Phosphate, Laboratory Biomarker Analysis, Melphalan, Mycophenolate Mofetil, Peripheral Blood Stem Cell Transplantation, Tacrolimus, Total-Body Irradiation
Procedure · Drug · Other + 1 more
Lead sponsor
Fred Hutchinson Cancer Center
Other
Eligibility
Up to 75 Years
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2018
U.S. locations
2
States / cities
Seattle, Washington • Milwaukee, Wisconsin
Conditions
Pharmacokinetics of ASP015K, Drug Interactions, Healthy Subjects
Interventions
ASP015K, Tacrolimus
Drug
Lead sponsor
Astellas Pharma Inc
Industry
Eligibility
18 Years to 65 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009
U.S. locations
1
States / cities
Miami, Florida
Conditions
Sickle Cell Disease, Beta Thalassemia-Major
Interventions
alemtuzumab (Campath IH), Fludarabine, Melphalan, Cyclosporine, Mycophenolate mofetil, Tacrolimus, Hematopoietic Stem Cell Transplantation
Drug · Biological
Lead sponsor
Northwell Health
Other
Eligibility
1 Year to 21 Years
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2019
U.S. locations
1
States / cities
New Hyde Park, New York
Conditions
Hematopoietic Stem Cell Transplant, GVHD
Interventions
70% Ethanol
Other
Lead sponsor
Nationwide Children's Hospital
Other
Eligibility
3 Months to 30 Years
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
1
States / cities
Columbus, Ohio
Conditions
Prostate Cancer
Interventions
Bone marrow transplantation, Cytoxan, testosterone cypionate
Procedure · Drug
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Other
Eligibility
18 Years to 75 Years · Male only
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2021
U.S. locations
1
States / cities
Baltimore, Maryland