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Terminated Not applicable Interventional Results available

Busulfan and Cyclophosphamide Followed By ALLO BMT

NCT01685411
Conditions
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome
Interventions
Allopurinol, Keppra, Busulfan, Cyclophosphamide, Tacrolimus, Mycophenolate mofetil, Allogeneic hematopoietic stem cell transplant, Filgrastim, antithymocyte globulin
Drug · Biological
Lead sponsor
Masonic Cancer Center, University of Minnesota
Other
Eligibility
Up to 44 Years
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2020
U.S. locations
1
States / cities
Minneapolis, Minnesota
Conditions
Acute Myeloid Leukemia, Juvenile Myelomonocytic Leukemia, Myelodysplastic Syndrome
Interventions
Gemtuzumab Ozogamicin, Busulfan, Cyclophosphamide, Thymoglobulin, Tacrolimus, Mycophenolate Mofetil, Methotrexate
Drug
Lead sponsor
New York Medical College
Other
Eligibility
Up to 30 Years
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2013
U.S. locations
1
States / cities
New York, New York
Conditions
Kidney Transplantation
Interventions
AEB071
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
124 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2007
U.S. locations
23
States / cities
Los Angeles, California • San Diego, California • San Francisco, California + 17 more
Conditions
GATA2, Immunodeficiency
Interventions
Mycophenolate Mofetil, Tacrolimus, Post-Transplant Cyclophosphamide, Total Body Irradiation, Hematopoietic Cell Transplant, Briquilimab, Cyclophosphamide, Fludarabine, Bone Marrow Biopsy, Bone Marrow Aspirate, 2D echo, EKG, PFT's, CT scan of chest, abdomen and pelvis
Drug · Radiation · Procedure + 1 more
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
6 Years to 70 Years
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2028
U.S. locations
1
States / cities
Bethesda, Maryland
Conditions
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Previously Treated Myelodysplastic Syndrome, Refractory Chronic Lymphocytic Leukemia, Refractory Plasma Cell Myeloma, Waldenstrom Macroglobulinemia, Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Promyelocytic Leukemia With t(15;17)(q22;q12); PML-RARA, Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Burkitt Lymphoma, Childhood Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Lymphoma, Childhood Myelodysplastic Syndrome, Stage II Contiguous Adult Burkitt Lymphoma, Stage II Contiguous Adult Diffuse Large Cell Lymphoma, Stage II Contiguous Adult Diffuse Mixed Cell Lymphoma, Stage II Contiguous Adult Diffuse Small Cleaved Cell Lymphoma, Stage II Adult Contiguous Immunoblastic Lymphoma, Stage II Contiguous Adult Lymphoblastic Lymphoma, Stage II Grade 1 Contiguous Follicular Lymphoma, Stage II Grade 2 Contiguous Follicular Lymphoma, Stage II Grade 3 Contiguous Follicular Lymphoma, Stage II Contiguous Mantle Cell Lymphoma, Stage II Non-Contiguous Adult Burkitt Lymphoma, Stage II Non-Contiguous Adult Diffuse Large Cell Lymphoma, Stage II Non-Contiguous Adult Diffuse Mixed Cell Lymphoma, Stage II Non-Contiguous Adult Diffuse Small Cleaved Cell Lymphoma, Stage II Adult Non-Contiguous Immunoblastic Lymphoma, Stage II Non-Contiguous Adult Lymphoblastic Lymphoma, Stage II Grade 1 Non-Contiguous Follicular Lymphoma, Stage II Grade 2 Non-Contiguous Follicular Lymphoma, Stage II Grade 3 Non-Contiguous Follicular Lymphoma, Stage II Non-Contiguous Mantle Cell Lymphoma, Stage II Small Lymphocytic Lymphoma, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Anaplastic Large Cell Lymphoma, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Burkitt Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Recurrent Childhood Hodgkin Lymphoma, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Secondary Myelodysplastic Syndrome, Stage I Adult Burkitt Lymphoma, Stage I Adult Diffuse Large Cell Lymphoma, Stage I Adult Diffuse Mixed Cell Lymphoma, Stage I Adult Immunoblastic Lymphoma, Stage I Adult Lymphoblastic Lymphoma, Stage I Childhood Anaplastic Large Cell Lymphoma, Stage I Childhood Large Cell Lymphoma, Stage I Childhood Lymphoblastic Lymphoma, Stage I Childhood Burkitt Lymphoma, Stage I Grade 1 Follicular Lymphoma, Stage I Grade 2 Follicular Lymphoma, Stage I Grade 3 Follicular Lymphoma, Stage I Mantle Cell Lymphoma, Stage I Marginal Zone Lymphoma, Stage I Small Lymphocytic Lymphoma, Stage II Childhood Anaplastic Large Cell Lymphoma, Stage II Childhood Lymphoblastic Lymphoma, Stage II Childhood Burkitt Lymphoma, Stage III Adult Burkitt Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma, Stage III Adult Diffuse Mixed Cell Lymphoma, Stage III Adult Diffuse Small Cleaved Cell Lymphoma, Stage III Adult Immunoblastic Lymphoma, Stage III Adult Lymphoblastic Lymphoma, Stage III Childhood Anaplastic Large Cell Lymphoma, Stage III Childhood Large Cell Lymphoma, Stage III Childhood Lymphoblastic Lymphoma, Stage III Childhood Burkitt Lymphoma, Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Grade 3 Follicular Lymphoma, Stage III Mantle Cell Lymphoma, Stage III Marginal Zone Lymphoma, Stage III Small Lymphocytic Lymphoma, Stage IV Adult Burkitt Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma, Stage IV Adult Diffuse Mixed Cell Lymphoma, Stage IV Adult Diffuse Small Cleaved Cell Lymphoma, Stage IV Adult Immunoblastic Lymphoma, Stage IV Adult Lymphoblastic Lymphoma, Stage IV Childhood Anaplastic Large Cell Lymphoma, Stage IV Childhood Large Cell Lymphoma, Stage IV Childhood Lymphoblastic Lymphoma, Stage IV Childhood Burkitt Lymphoma, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Grade 3 Follicular Lymphoma, Stage IV Mantle Cell Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Small Lymphocytic Lymphoma
Interventions
Fludarabine Phosphate, Total-Body Irradiation, Peripheral Blood Stem Cell Transplantation, Allogeneic Hematopoietic Stem Cell Transplantation, Tacrolimus, Mycophenolate Mofetil, Sirolimus
Drug · Radiation · Procedure
Lead sponsor
Fred Hutchinson Cancer Center
Other
Eligibility
Not listed
Enrollment
210 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2015
U.S. locations
7
States / cities
Denver, Colorado • Atlanta, Georgia • Salt Lake City, Utah + 2 more
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
Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
Interventions
filgrastim, cyclophosphamide, fludarabine phosphate, mycophenolate mofetil, tacrolimus, allogeneic bone marrow transplantation, peripheral blood stem cell transplantation, radiation therapy
Biological · Drug · Procedure + 1 more
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Other
Eligibility
18 Years to 75 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2002
U.S. locations
1
States / cities
Baltimore, Maryland
Conditions
Leukemia, Lymphoma
Interventions
therapeutic allogeneic lymphocytes, cyclophosphamide, cyclosporine, fludarabine phosphate, methotrexate, mycophenolate mofetil, tacrolimus, peripheral blood stem cell transplantation, radiation therapy
Biological · Drug · Procedure + 1 more
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
18 Years to 75 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2003
U.S. locations
19
States / cities
Denver, Colorado • Newark, Delaware • Orlando, Florida + 15 more
Conditions
Transplant; Failure, Kidney
Interventions
Tacrolimus, Everolimus, Enteric Coated Mycophenolate Sodium (EC-MPS), Corticosteroids
Drug
Lead sponsor
Gaetano Ciancio
Other
Eligibility
18 Years to 75 Years
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
1
States / cities
Miami, Florida
Conditions
Hyperkalemia, Kidney Transplant
Interventions
Patiromer
Drug
Lead sponsor
The Rogosin Institute
Other
Eligibility
18 Years and older
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
1
States / cities
New York, New York
Conditions
Systemic Scleroderma
Interventions
fludarabine phosphate, total-body irradiation, tacrolimus, mycophenolate mofetil, rituximab, cyclophosphamide, nonmyeloablative allogeneic hematopoietic stem cell transplantation, peripheral blood stem cell transplantation
Drug · Radiation · Biological + 1 more
Lead sponsor
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Other
Eligibility
18 Years to 65 Years
Healthy volunteers
Healthy volunteers not accepted
U.S. locations
1
States / cities
Seattle, Washington
Conditions
Hepatitis C, Hepatitis C, Chronic, Nonimmune Nonviral Causes of Liver Failure
Interventions
calcineurin inhibitor-based immunosuppression, liver transplant, corticosteroids, immunosuppression withdrawal
Drug · Procedure · Other
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years and older
Enrollment
275 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2015
U.S. locations
8
States / cities
San Francisco, California • Denver, Colorado • Chicago, Illinois + 5 more
Conditions
Renal Transplant
Interventions
Sirolimus
Drug
Lead sponsor
Pediatric Nephrology of Alabama
Other
Eligibility
Up to 19 Years
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2012
U.S. locations
4
States / cities
Birmingham, Alabama • Los Angeles, California • Stanford, California + 1 more
Conditions
Kidney Transplant Rejection
Interventions
Frexalimab, Tacrolimus, rabbit anti-thymocyte globulin, mycophenolate mofetil, mycophenolate sodium, methylprednisolone, prednisone
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 70 Years
Enrollment
526 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2033
U.S. locations
14
States / cities
San Francisco, California • Atlanta, Georgia • Hines, Illinois + 9 more
Conditions
Type 1 Diabetes Mellitus
Interventions
Allogeneic Pancreatic Islet Cells, Belatacept, Basiliximab, Mycophenolate Mofetil, Tacrolimus, Intraportal infusion of islet cells
Biological · Drug · Procedure
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 65 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2013
U.S. locations
1
States / cities
Atlanta, Georgia
Conditions
Liver Transplantation
Interventions
MMF(1000mg bid) + tacrolimus + standard of care medications, sotrastaurin (200mg bid) + tacrolimus + standard of care medications, sotrastaurin (300 mg bid) + tacrolimus + standard of care medications
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2012
U.S. locations
8
States / cities
Los Angeles, California • San Francisco, California • Detroit, Michigan + 5 more
Conditions
Lung Transplant Rejection, Antibody-mediated Rejection
Interventions
Belatacept, Tacrolimus, ATG, Mycophenolate Mofetil, Methylprednisolone, Prednisone
Drug
Lead sponsor
Washington University School of Medicine
Other
Eligibility
18 Years to 70 Years
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
2
States / cities
St Louis, Missouri • Houston, Texas
Conditions
Rheumatic Disease
Interventions
Methotrexate, Sulfasalazine, Hydroxychloroquine, Leflunomide, Azathioprine, Mycophenolate, Cyclosporine, Tacrolimus, Etanercept, Adalimumab, Golimumab, Certolizumab, Infliximab, Rituximab, Belimumab, Tocilizumab, Anakinra, Canakinumab, Abatacept, Secukinumab, Ixekizumab, Bimekizumab, Ustekinumab, Guselkumab, Risankizumab, Tofacitinib, Upadacitinib
Drug · Biological
Lead sponsor
NYU Langone Health
Other
Eligibility
18 Years and older
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
1
States / cities
New York, New York
Conditions
Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
Interventions
anti-thymocyte globulin, fludarabine phosphate, Melphalan, mycophenolate mofetil, tacrolimus, umbilical cord blood transplantation
Biological · Drug · Procedure
Lead sponsor
Northside Hospital, Inc.
Other
Eligibility
18 Years to 65 Years
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2009
U.S. locations
1
States / cities
Atlanta, Georgia
Conditions
Chronic Graft-versus-host-disease
Interventions
INCA034176, Best available Treatment (BAT)
Drug
Lead sponsor
Incyte Corporation
Industry
Eligibility
2 Years to 17 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
11
States / cities
Duarte, California • Los Angeles, California • Palo Alto, California + 8 more
Conditions
Accelerated Phase Chronic Myelogenous Leukemia, Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Blastic Phase Chronic Myelogenous Leukemia, Cutaneous B-cell Non-Hodgkin Lymphoma, de Novo Myelodysplastic Syndromes, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma, Intraocular Lymphoma, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Nodal Marginal Zone B-cell Lymphoma, Noncutaneous Extranodal Lymphoma, Peripheral T-cell Lymphoma, Post-transplant Lymphoproliferative Disorder, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Hairy Cell Leukemia, Refractory Multiple Myeloma, Relapsing Chronic Myelogenous Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, T-cell Large Granular Lymphocyte Leukemia, Testicular Lymphoma, Waldenström Macroglobulinemia
Interventions
cyclophosphamide, fludarabine phosphate, mycophenolate mofetil, allogeneic hematopoietic stem cell transplantation, umbilical cord blood transplantation, double-unit umbilical cord blood transplantation, total-body irradiation, tacrolimus, peripheral blood stem cell transplantation
Drug · Procedure · Radiation
Lead sponsor
University of Medicine and Dentistry of New Jersey
Other
Eligibility
18 Years to 65 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2017
U.S. locations
1
States / cities
New Brunswick, New Jersey
Conditions
Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Precancerous Condition, Secondary Myelofibrosis
Interventions
Busulfan, Cytarabine, Fludarabine phosphate, mycophenolate mofetil, tacrolimus, allogeneic hematopoietic stem cell transplantation, umbilical cord blood transplantation, total-body irradiation
Drug · Procedure · Radiation
Lead sponsor
Barbara Ann Karmanos Cancer Institute
Other
Eligibility
Up to 69 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2015
U.S. locations
1
States / cities
Detroit, Michigan
Conditions
End-stage Renal Failure, Kidney Graft Rejection
Interventions
Blood drawing for immune monitoring and questionnaires
Other
Lead sponsor
University of Regensburg
Other
Eligibility
18 Years and older
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
2
States / cities
San Francisco, California • Boston, Massachusetts
Conditions
Transplant Rejection
Interventions
BIVV020 (SAR445088), Intravenous immunoglobulin (IVIg), Rituximab or biosimilar, Antithymocyte globulin (ATG), Tacrolimus, Mycophenolate, Corticosteroids
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
7
States / cities
Los Angeles, California • San Francisco, California • Boston, Massachusetts + 2 more