Acute Myeloid Leukemia, Childhood News

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||||||||||  human allogeneic myeloid progenitor cells (CLT-008) / Cellerant Therap
Enrollment change, Post-transplantation:  Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Cord Blood Transplant for Hematologic Malignancy (clinicaltrials.gov) -  Oct 4, 2012
P1, N=40, Recruiting,  Sponsor: Cellerant Therapeutics
N=22 --> 40

|||||||||| Biomarker, Trial initiation date: Studying Biomarkers in Cell Samples From Young Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - Oct 2, 2012
P=N/A, N=75, Active, not recruiting, Sponsor: Children's Oncology Group
N=22 --> 40 Initiation date: Jan 2010 --> Sep 2012

||||||||||  amphotericin b liposome / Generic mfg.
Enrollment change:  Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients (clinicaltrials.gov) -  Sep 19, 2012
P3, N=115, Completed,  Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Initiation date: Jan 2010 --> Sep 2012 N=450 --> 115

||||||||||  piperacillin sodium/tazobactam sodium / Generic mfg., vancomycin / Generic mfg.
Enrollment change:  Prevention of Infection in Patients With Hematologic Cancer and Persistent Fever Caused by a Low White Blood Cell Count (clinicaltrials.gov) -  Sep 19, 2012
P3, N=859, Completed,  Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
N=450 --> 115 N=500 --> 859

||||||||||  amphotericin b liposome / Generic mfg.
Trial completion:  Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients (clinicaltrials.gov) -  Sep 19, 2012
P3, N=115, Completed,  Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
N=500 --> 859 Active, not recruiting --> Completed

||||||||||  piperacillin sodium/tazobactam sodium / Generic mfg., vancomycin / Generic mfg.
Trial completion:  Prevention of Infection in Patients With Hematologic Cancer and Persistent Fever Caused by a Low White Blood Cell Count (clinicaltrials.gov) -  Sep 19, 2012
P3, N=859, Completed,  Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Neupogen (filgrastim) / Kyowa Kirin, Amgen
Trial termination:  Donor Stem Cell Transplant Followed By Donor White Blood Cell Infusions in Treating Young Patients With Hematologic Cancer (clinicaltrials.gov) -  Sep 11, 2012
P=N/A, N=8, Terminated,  Sponsor: University of California, San Francisco
Active, not recruiting --> Completed Completed --> Terminated; lack of efficacy

||||||||||  Neupogen (filgrastim) / Kyowa Kirin, Amgen
Enrollment change:  Donor Stem Cell Transplant Followed By Donor White Blood Cell Infusions in Treating Young Patients With Hematologic Cancer (clinicaltrials.gov) -  Sep 11, 2012
P=N/A, N=8, Terminated,  Sponsor: University of California, San Francisco
Completed --> Terminated; lack of efficacy N=10 --> 8

|||||||||| Biomarker, Trial completion: Biomarkers in Samples From Patients With Down Syndrome and Acute Megakaryoblastic Leukemia (clinicaltrials.gov) - Sep 4, 2012
P=N/A, N=10, Completed, Sponsor: Children's Oncology Group
N=10 --> 8 Active, not recruiting --> Completed

|||||||||| Biomarker, Enrollment closed, IO biomarker: Studying Biomarkers in Samples From Younger Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - Aug 22, 2012
P=N/A, N=20, Active, not recruiting, Sponsor: Children's Oncology Group
Active, not recruiting --> Completed Not yet recruiting --> Active, not recruiting

|||||||||| Enrollment open: Total Marrow Irradiation for Refractory Acute Leukemia (clinicaltrials.gov) - Aug 12, 2012
P1, N=20, Recruiting, Sponsor: Masonic Cancer Center, University of Minnesota
Not yet recruiting --> Active, not recruiting Suspended --> Recruiting

|||||||||| Enrollment change: Chemotherapy and Bone Marrow Transplantation in Treating Patients Acute Myeloid With Leukemia or Myelodysplastic Syndrome (clinicaltrials.gov) - Aug 5, 2012
P2, N=280, Completed, Sponsor: Barbara Ann Karmanos Cancer Institute
Suspended --> Recruiting N=40 --> 280

|||||||||| Trial termination: Study of Natural Killer Cells in Bone Marrow and Blood Samples From Patients With and Without Hematologic Cancer (clinicaltrials.gov) - Aug 1, 2012
P=N/A, N=34, Terminated, Sponsor: Case Comprehensive Cancer Center
N=40 --> 280 Recruiting --> Terminated; PI closed lab

||||||||||  Mozobil (plerixafor) / Sanofi
New P1 trial:  BMTAMD3100: AMD3100 for Sensitizing in Allogeneic Blood or Marrow Transplant for Chemotherapy Resistant Pediatric Acute Leukemia (clinicaltrials.gov) -  Jul 31, 2012
P1, N=1, Terminated,  Sponsor: Emory University

|||||||||| Enrollment closed: Studying Genes in Samples From Younger Patients With Acute Megakaryoblastic Leukemia (clinicaltrials.gov) - Jul 26, 2012
P=N/A, N=100, Active, not recruiting, Sponsor: Children's Oncology Group
Recruiting --> Terminated; PI closed lab Not yet recruiting --> Active, not recruiting

||||||||||  melphalan / Generic mfg., clofarabine / Generic mfg.
Enrollment change:  Clofarabine and High-Dose Melphalan Followed by Donor Stem Cell Transplant in Patients With Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, or Myelodysplastic Syndromes (clinicaltrials.gov) -  Jul 15, 2012
P1, N=20, Completed,  Sponsor: City of Hope Medical Center
Not yet recruiting --> Active, not recruiting N=36 --> 20

||||||||||  fludarabine IV / Generic mfg., busulfan / Generic mfg.
Trial completion:  Donor Stem Cell Transplant After Busulfan, Fludarabine, and Antithymocyte Globulin in Treating Patients With Hematologic Cancer or Myelodysplastic Syndrome (clinicaltrials.gov) -  Jul 15, 2012
P2, N=54, Completed,  Sponsor: Asan Medical Center
N=36 --> 20 Recruiting --> Completed

|||||||||| Trial withdrawal: Recombinant Human Mannose-Binding Lectin (MBL) in Treating Young Patients With MBL Deficiency and Fever and Neutropenia (clinicaltrials.gov) - Jun 18, 2012
P1, N=0, Withdrawn, Sponsor: Enzon Pharmaceuticals, Inc.
Recruiting --> Completed Recruiting --> Withdrawn

|||||||||| Enrollment change: Recombinant Human Mannose-Binding Lectin (MBL) in Treating Young Patients With MBL Deficiency and Fever and Neutropenia (clinicaltrials.gov) - Jun 18, 2012
P1, N=0, Withdrawn, Sponsor: Enzon Pharmaceuticals, Inc.
Recruiting --> Withdrawn N=48 --> 0

|||||||||| Trial completion: Irradiated Donor Lymphocyte Infusion in Treating Patients With Relapsed or Refractory Hematologic Cancer or Solid Tumor (clinicaltrials.gov) - Jun 12, 2012
P1, N=37, Completed, Sponsor: University of Medicine and Dentistry New Jersey
N=48 --> 0 Active, not recruiting --> Completed

|||||||||| Trial termination: Partially HLA-Matched Irradiated Allogeneic Cellular Therapy After Reduced Intensity Total Body Irradiation (clinicaltrials.gov) - Jun 11, 2012
P1, N=4, Terminated, Sponsor: University of Medicine and Dentistry New Jersey
Active, not recruiting --> Completed Recruiting --> Terminated; Slow accrual

|||||||||| Enrollment change: Partially HLA-Matched Irradiated Allogeneic Cellular Therapy After Reduced Intensity Total Body Irradiation (clinicaltrials.gov) - Jun 11, 2012
P1, N=4, Terminated, Sponsor: University of Medicine and Dentistry New Jersey
Recruiting --> Terminated; Slow accrual N=24 --> 4

||||||||||  fludarabine IV / Generic mfg.
Enrollment closed:  Low-Dose Total-Body Irradiation and Fludarabine Phosphate Followed by Unrelated Donor Stem Cell Transplant in Treating Patients With Fanconi Anemia (clinicaltrials.gov) -  May 21, 2012
P1, N=2, Active, not recruiting,  Sponsor: Fred Hutchinson Cancer Research Center
N=24 --> 4 Completed --> Active, not recruiting

|||||||||| Trial initiation date: Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting (clinicaltrials.gov) - May 7, 2012
P=N/A, N=0, Withdrawn, Sponsor: Stanford University
Completed --> Active, not recruiting Initiation date: Dec 2011 --> May 2012

|||||||||| Trial termination: Donor T Cells in Treating Patients With High-Risk Hematologic Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant (clinicaltrials.gov) - Apr 17, 2012
P1, N=3, Terminated, Sponsor: Masonic Cancer Center, University of Minnesota
Initiation date: Dec 2011 --> May 2012 Active, not recruiting --> Terminated; Slow accrual.

|||||||||| Enrollment change: Donor T Cells in Treating Patients With High-Risk Hematologic Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant (clinicaltrials.gov) - Apr 17, 2012
P1, N=3, Terminated, Sponsor: Masonic Cancer Center, University of Minnesota
Active, not recruiting --> Terminated; Slow accrual. N=32 --> 3

||||||||||  Neupogen (filgrastim) / Kyowa Kirin, Amgen
Enrollment closed:  Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Malignancies or Secondary Myelodysplasia Previously Treated With High-Dose Chemotherapy and Autologous Stem Cell Transplant (clinicaltrials.gov) -  Mar 30, 2012
P2, N=88, Active, not recruiting,  Sponsor: Cancer and Leukemia Group B
N=32 --> 3 Recruiting --> Active, not recruiting

|||||||||| Enrollment closed, HEOR: Massage Therapy Given by Caregiver in Treating Quality of Life of Young Patients Undergoing Treatment for Cancer (clinicaltrials.gov) - Mar 21, 2012
P=N/A, N=80, Active, not recruiting, Sponsor: Comprehensive Cancer Center of Wake Forest University
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting

||||||||||  Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
Enrollment closed:  Fludarabine Phosphate, Busulfan, and Anti-Thymocyte Globulin Followed By Donor Peripheral Blood Stem Cell Transplant, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Malignancies (clinicaltrials.gov) -  Mar 19, 2012
P2, N=23, Active, not recruiting,  Sponsor: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Recruiting --> Active, not recruiting Completed --> Active, not recruiting

|||||||||| Trial withdrawal: Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer (clinicaltrials.gov) - Mar 15, 2012
P=N/A, N=0, Withdrawn, Sponsor: Case Comprehensive Cancer Center
Completed --> Active, not recruiting Terminated --> Withdrawn

|||||||||| Trial completion: Umbilical Cord Blood Transplantation in Treating Patients With High-Risk Hematologic Cancer (clinicaltrials.gov) - Mar 13, 2012
P2, N=44, Completed, Sponsor: Case Comprehensive Cancer Center
Terminated --> Withdrawn Active, not recruiting --> Completed

|||||||||| Enrollment closed, Minimal residual disease: Comparison of Laboratory Test Results of Minimal-Residual Disease in Samples From Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - Mar 1, 2012
P=N/A, N=10, Active, not recruiting, Sponsor: Children's Oncology Group
Active, not recruiting --> Completed Not yet recruiting --> Active, not recruiting

||||||||||  Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
Enrollment change:  Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer (clinicaltrials.gov) -  Feb 21, 2012
P2, N=32, Completed,  Sponsor: City of Hope Medical Center
Not yet recruiting --> Active, not recruiting N=60 --> 32

||||||||||  Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
Trial completion:  Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer (clinicaltrials.gov) -  Feb 21, 2012
P2, N=32, Completed,  Sponsor: City of Hope Medical Center
N=60 --> 32 Active, not recruiting --> Completed

||||||||||  fludarabine IV / Generic mfg., busulfan / Generic mfg.
Enrollment closed:  Reduced-Intensity Busulfan and Fludarabine With or Without Antithymocyte Globulin Followed by Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease (clinicaltrials.gov) -  Feb 18, 2012
P2, N=70, Active, not recruiting,  Sponsor: UNC Lineberger Comprehensive Cancer Center
Active, not recruiting --> Completed Recruiting --> Active, not recruiting

|||||||||| Biomarker, Enrollment closed: Studying Biomarker Expression in Samples From Patients With Down Syndrome and Acute Myeloid Leukemia or Other Transient Myeloproliferative Disorder (clinicaltrials.gov) - Feb 13, 2012
P=N/A, N=60, Active, not recruiting, Sponsor: Children's Oncology Group
Recruiting --> Active, not recruiting Not yet recruiting --> Active, not recruiting

|||||||||| Enrollment closed: Studying DNA in Samples From Younger Patients With Down Syndrome and Acute Myeloid Leukemia Treated on COG-AAML0431 Clinical Trial (clinicaltrials.gov) - Feb 13, 2012
P=N/A, N=10, Active, not recruiting, Sponsor: Children's Oncology Group
Not yet recruiting --> Active, not recruiting Not yet recruiting --> Active, not recruiting

||||||||||  AT9283 / Otsuka
Enrollment open:  CRUK-CR0708-12: AT9283 in Treating Young Patients With Relapsed or Refractory Acute Leukemia (clinicaltrials.gov) -  Feb 5, 2012
P1/2, N=15, Recruiting,  Sponsor: Cancer Research UK
Not yet recruiting --> Active, not recruiting Not yet recruiting --> Recruiting

||||||||||  cyclophosphamide / Generic mfg., busulfan / Generic mfg.
Enrollment change, Post-transplantation:  Combination Chemotherapy, Bone Marrow Transplant, and Post Transplant Cyclophosphamide for Hematologic Cancer (clinicaltrials.gov) -  Jan 24, 2012
P2, N=92, Active, not recruiting,  Sponsor: Sidney Kimmel Comprehensive Cancer Center
Not yet recruiting --> Recruiting N=60 --> 92

|||||||||| Trial initiation date, Minimal residual disease: MRD Testing Before and After Hematopoietic Cell Transplantation for Pediatric Acute Myeloid Leukemia (clinicaltrials.gov) - Jan 19, 2012
P=N/A, N=150, Recruiting, Sponsor: Center for International Blood and Marrow Transplant Research
N=60 --> 92 Initiation date: Jan 2011 --> Oct 2011

||||||||||  Proleukin (aldesleukin) / Novartis, Prometheus, Iovance Biotherap
Trial termination, Post-transplantation:  Chemotherapy, Total-Body Irradiation, Donor Natural Killer Cell Infusion, Aldesleukin, and UCB Transplant in Treating Patients With Relapsed or Refractory AML (clinicaltrials.gov) -  Dec 19, 2011
P2, N=2, Terminated,  Sponsor: Masonic Cancer Center, University of Minnesota
Initiation date: Jan 2011 --> Oct 2011 Suspended --> Terminated; Due to graft failure.

||||||||||  Proleukin (aldesleukin) / Novartis, Prometheus, Iovance Biotherap
Enrollment change, Post-transplantation:  Chemotherapy, Total-Body Irradiation, Donor Natural Killer Cell Infusion, Aldesleukin, and UCB Transplant in Treating Patients With Relapsed or Refractory AML (clinicaltrials.gov) -  Dec 19, 2011
P2, N=2, Terminated,  Sponsor: Masonic Cancer Center, University of Minnesota
Suspended --> Terminated; Due to graft failure. N=29 --> 2

|||||||||| Biomarker, Trial completion: Biomarkers in Tissue Samples From Patients With Acute Promyelocytic Leukemia (clinicaltrials.gov) - Oct 24, 2011
P=N/A, N=10, Completed, Sponsor: Children's Oncology Group
N=29 --> 2 Active, not recruiting --> Completed

||||||||||  melphalan / Generic mfg., clofarabine / Generic mfg.
Trial completion:  Clofarabine and High-Dose Melphalan Followed by Donor Stem Cell Transplant in Patients With Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, or Myelodysplastic Syndromes (clinicaltrials.gov) -  Oct 13, 2011
P1, N=20, Completed,  Sponsor: City of Hope Medical Center
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Trial completion: Non-Ablative Allo HSCT For Hematologic Malignancies or SAA (clinicaltrials.gov) - Oct 12, 2011
P2, N=58, Completed, Sponsor: Case Comprehensive Cancer Center
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Trial completion: Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer (clinicaltrials.gov) - Oct 4, 2011
P2, N=34, Completed, Sponsor: Case Comprehensive Cancer Center
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Enrollment open, Minimal residual disease: MRD Testing Before and After Hematopoietic Cell Transplantation for Pediatric Acute Myeloid Leukemia (clinicaltrials.gov) - Oct 3, 2011
P=N/A, N=150, Recruiting, Sponsor: Center for International Blood and Marrow Transplant Research
Active, not recruiting --> Completed Active, not recruiting --> Recruiting

|||||||||| Enrollment closed: Study of Proteins in Promoting Chemotherapy Resistance in Samples From Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - Oct 3, 2011
P=N/A, N=40, Active, not recruiting, Sponsor: Children's Oncology Group
Active, not recruiting --> Recruiting Not yet recruiting --> Active, not recruiting

|||||||||| Enrollment change: Metabolic Syndrome in Childhood Cancer Survivors (clinicaltrials.gov) - Sep 28, 2011
P=N/A, N=512, Completed, Sponsor: Masonic Cancer Center, University of Minnesota
Not yet recruiting --> Active, not recruiting N=700 --> 512

|||||||||| Trial completion: Metabolic Syndrome in Childhood Cancer Survivors (clinicaltrials.gov) - Sep 28, 2011
P=N/A, N=512, Completed, Sponsor: Masonic Cancer Center, University of Minnesota
N=700 --> 512 Active, not recruiting --> Completed



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