Acute Myeloid Leukemia, Childhood News

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|||||||||| Biomarker, Trial primary completion date: Studying Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia Previously Enrolled on Clinical Trial POG-9421 (clinicaltrials.gov) - May 5, 2015
P=N/A, N=90, Active, not recruiting, Sponsor: Children's Oncology Group
Trial primary completion date: Jan 2011 --> Jan 2100

||||||||||  LMB-2 / National Cancer Institute
Trial completion:  LMB-2 Immunotoxin in Treating Young Patients With Relapsed or Refractory Leukemia or Lymphoma (clinicaltrials.gov) -  Apr 28, 2015
P1, N=40, Completed,  Sponsor: National Cancer Institute (NCI)
Trial primary completion date: Jan 2011 --> Jan 2100 Recruiting --> Completed

||||||||||  arsenic trioxide / Generic mfg.
Trial completion:  Arsenic Trioxide in Treating Young Patients With Refractory Leukemia or Lymphoma (clinicaltrials.gov) -  Apr 27, 2015
P1, N=0, Completed,  Sponsor: National Cancer Institute (NCI)
Recruiting --> Completed No longer recruiting --> Completed

||||||||||  Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
Clinical:  Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies (clinicaltrials.gov) -  Apr 14, 2015
P2, N=47, Active, not recruiting,  Sponsor: Case Comprehensive Cancer Center
No longer recruiting --> Completed Trial primary completion date: Mar 2015 --> Sep 2015

||||||||||  decitabine / Generic mfg.
Enrollment change, Trial withdrawal:  A Randomized Study of Epigenetic Priming Using Decitabine With Front Line Induction Chemotherapy Compared With Immediate Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects (clinicaltrials.gov) -  Apr 13, 2015
P2, N=0, Withdrawn,  Sponsor: Eisai Inc.
Trial primary completion date: Mar 2015 --> Sep 2015 N=40 --> 0 | Terminated --> Withdrawn

||||||||||  Depocyte (liposomal cytarabine) / Mundipharma, Leadiant Biosci
Trial completion, Enrollment change, Trial primary completion date:  Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease (clinicaltrials.gov) -  Apr 3, 2015
P=N/A, N=2, Completed,  Sponsor: Barbara Ann Karmanos Cancer Institute
N=40 --> 0 | Terminated --> Withdrawn Recruiting --> Completed | N=29 --> 2 | Trial primary completion date: Dec 2016 --> Jan 2015

||||||||||  sirolimus / Generic mfg.
Trial termination:  Sirolimus in Treating Young Patients With Relapsed or Refractory Acute Leukemia or Non-Hodgkin's Lymphoma (clinicaltrials.gov) -  Mar 12, 2015
P1, N=10, Terminated,  Sponsor: Children's Hospital of Philadelphia
Recruiting --> Completed | N=29 --> 2 | Trial primary completion date: Dec 2016 --> Jan 2015 Suspended --> Terminated; Recruiting/enrolling participants halted prematurely but potentially will resume

|||||||||| Trial primary completion date, Minimal residual disease: MRD Testing Before and After Hematopoietic Cell Transplantation for Pediatric Acute Myeloid Leukemia (clinicaltrials.gov) - Mar 10, 2015
P=N/A, N=150, Active, not recruiting, Sponsor: Center for International Blood and Marrow Transplant Research
Suspended --> Terminated; Recruiting/enrolling participants halted prematurely but potentially will resume Trial primary completion date: Mar 2015 --> Feb 2017

||||||||||  fludarabine IV / Generic mfg., cyclophosphamide / Generic mfg.
Trial primary completion date:  Chemotherapy and a Donor Natural Killer Cell Infusion in Treating Patients With Relapsed or Persistent Leukemia or Myelodysplastic Syndrome After a Donor Stem Cell Transplant (clinicaltrials.gov) -  Mar 7, 2015
P2, N=30, Active, not recruiting,  Sponsor: Memorial Sloan Kettering Cancer Center.
Trial primary completion date: Mar 2015 --> Feb 2017 Trial primary completion date: Dec 2014 --> Dec 2015

||||||||||  fludarabine IV / Generic mfg., mycophenolate mofetil / Generic mfg.
Trial primary completion date, Combination therapy, IO biomarker, Post-transplantation:  Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer (clinicaltrials.gov) -  Mar 7, 2015
P=N/A, N=20, Recruiting,  Sponsor: Fred Hutchinson Cancer Research Center
Trial primary completion date: Dec 2014 --> Dec 2015 Trial primary completion date: Dec 2014 --> Dec 2015

||||||||||  sirolimus / Generic mfg.
Enrollment change, Combination therapy:  Prevention of Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Receiving a Bone Marrow Transplant (clinicaltrials.gov) -  Mar 7, 2015
P1/2, N=0, Withdrawn,  Sponsor: Fred Hutchinson Cancer Research Center
Trial primary completion date: Dec 2014 --> Dec 2015 N=36 --> 0

||||||||||  clofarabine / Generic mfg.
Trial completion:  Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients (clinicaltrials.gov) -  Mar 4, 2015
P2, N=40, Completed,  Sponsor: Genzyme, a Sanofi Company
N=36 --> 0 No longer recruiting --> Completed

||||||||||  Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
Clinical:  Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies (clinicaltrials.gov) -  Feb 19, 2015
P2, N=47, Active, not recruiting,  Sponsor: Case Comprehensive Cancer Center
No longer recruiting --> Completed Trial primary completion date: Mar 2014 --> Mar 2015

||||||||||  decitabine / Generic mfg.
Enrollment closed:  AR-42 and Decitabine in Treating Patients With Acute Myeloid Leukemia (clinicaltrials.gov) -  Feb 12, 2015
P1, N=54, Active, not recruiting,  Sponsor: Alison Walker
Trial primary completion date: Mar 2014 --> Mar 2015 Recruiting --> Active, not recruiting

|||||||||| Trial completion: A Pilot Study to Evaluate the Co-Infusion of Ex Vivo Expanded Cord Blood Cells With an Unmanipulated Cord Blood Unit in Patients Undergoing Cord Blood Transplant for Hematologic Malignancies (clinicaltrials.gov) - Feb 11, 2015
P1, N=23, Completed, Sponsor: Fred Hutchinson Cancer Research Center
Recruiting --> Active, not recruiting Active, not recruiting --> Completed

||||||||||  AT9283 / Otsuka
Trial completion, Enrollment change:  CRUK-CR0708-12: AT9283 in Treating Young Patients With Relapsed or Refractory Acute Leukemia (clinicaltrials.gov) -  Dec 5, 2014
P1/2, N=7, Completed,  Sponsor: Cancer Research UK
Active, not recruiting --> Completed Recruiting --> Completed | N=15 --> 7

|||||||||| Trial completion: Low-Dose or High-Dose Conditioning Followed by Peripheral Blood Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia (clinicaltrials.gov) - Oct 31, 2014
P3, N=25, Completed, Sponsor: Fred Hutchinson Cancer Research Center
Recruiting --> Completed | N=15 --> 7 Active, not recruiting --> Completed

||||||||||  human allogeneic myeloid progenitor cells (CLT-008) / Cellerant Therap
Trial completion, Post-transplantation:  Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Cord Blood Transplant for Hematologic Malignancy (clinicaltrials.gov) -  Oct 27, 2014
P1, N=30, Completed,  Sponsor: Cellerant Therapeutics
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Enrollment closed, Minimal residual disease: MRD Testing Before and After Hematopoietic Cell Transplantation for Pediatric Acute Myeloid Leukemia (clinicaltrials.gov) - Oct 23, 2014
P=N/A, N=150, Active, not recruiting, Sponsor: Center for International Blood and Marrow Transplant Research
Active, not recruiting --> Completed Recruiting --> Active, not recruiting

||||||||||  Jakafi (ruxolitinib) / Incyte
Trial completion, Enrollment change, Trial primary completion date, Tumor mutational burden:  INCB18424 in Treating Young Patients With Relapsed or Refractory Solid Tumor, Leukemia, or Myeloproliferative Disease (clinicaltrials.gov) -  Oct 23, 2014
P1, N=49, Completed,  Sponsor: Children's Oncology Group
Recruiting --> Active, not recruiting Active, not recruiting --> Completed | N=106 --> 49 | Trial primary completion date: May 2015 --> Oct 2014

||||||||||  Jakafi (ruxolitinib) / Incyte
Trial primary completion date, Tumor mutational burden:  INCB18424 in Treating Young Patients With Relapsed or Refractory Solid Tumor, Leukemia, or Myeloproliferative Disease (clinicaltrials.gov) -  Oct 17, 2014
P1, N=106, Active, not recruiting,  Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | N=106 --> 49 | Trial primary completion date: May 2015 --> Oct 2014 Trial primary completion date: Oct 2014 --> May 2015

||||||||||  OXS-1550 / GT Biopharma
Trial completion, Trial primary completion date:  DT2219ARL for Relapsed or Refractory CD19 (+), CD 22 (+) B-Lineage Leukemia Or Lymphoma (clinicaltrials.gov) -  Sep 28, 2014
P1, N=30, Completed,  Sponsor: Masonic Cancer Center, University of Minnesota
Trial primary completion date: Oct 2014 --> May 2015 Recruiting --> Completed | Trial primary completion date: Nov 2015 --> Sep 2014

|||||||||| Trial primary completion date, Minimal residual disease: MRD Testing Before and After Hematopoietic Cell Transplantation for Pediatric Acute Myeloid Leukemia (clinicaltrials.gov) - Sep 9, 2014
P=N/A, N=150, Recruiting, Sponsor: Center for International Blood and Marrow Transplant Research
Recruiting --> Completed | Trial primary completion date: Nov 2015 --> Sep 2014 Trial primary completion date: Sep 2014 --> Mar 2015

||||||||||  human allogeneic myeloid progenitor cells (CLT-008) / Cellerant Therap
Enrollment closed, Enrollment change, Trial primary completion date, Post-transplantation:  Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Cord Blood Transplant for Hematologic Malignancy (clinicaltrials.gov) -  Aug 22, 2014
P1, N=30, Active, not recruiting,  Sponsor: Cellerant Therapeutics
Trial primary completion date: Sep 2014 --> Mar 2015 Recruiting --> Active, not recruiting | N=40 --> 30 | Trial primary completion date: Dec 2013 --> Jun 2014

|||||||||| Trial primary completion date, Post-transplantation: Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies (clinicaltrials.gov) - Aug 15, 2014
P2, N=42, Active, not recruiting, Sponsor: Fred Hutchinson Cancer Research Center
Recruiting --> Active, not recruiting | N=40 --> 30 | Trial primary completion date: Dec 2013 --> Jun 2014 Trial primary completion date: Sep 2014 --> Jun 2014

|||||||||| Enrollment change: Talotrexin in Treating Young Patients With Recurrent Solid Tumors or Leukemia That is Recurrent or Does Not Respond to Treatment (clinicaltrials.gov) - Aug 8, 2014
P1, N=0, Withdrawn, Sponsor: Children's Oncology Group
Trial primary completion date: Sep 2014 --> Jun 2014 N=36 --> 0

||||||||||  Jakafi (ruxolitinib) / Incyte
Enrollment closed, Tumor mutational burden:  INCB18424 in Treating Young Patients With Relapsed or Refractory Solid Tumor, Leukemia, or Myeloproliferative Disease (clinicaltrials.gov) -  Aug 8, 2014
P1, N=106, Active, not recruiting,  Sponsor: Children's Oncology Group
N=36 --> 0 Recruiting --> Active, not recruiting

|||||||||| Trial completion, Enrollment change, Minimal residual disease: Detection of Residual Disease in Children Receiving Therapy for Acute Myeloid Leukemia or Myelodysplastic Syndrome (clinicaltrials.gov) - Aug 6, 2014
P=N/A, N=496, Completed, Sponsor: Children's Oncology Group
Recruiting --> Active, not recruiting Active, not recruiting --> Completed | N=400 --> 496

||||||||||  docetaxel / Generic mfg.
Trial completion:  Docetaxel in Treating Children With Relapsed or Refractory Acute Lymphoblastic or Acute Myeloid Leukemia (clinicaltrials.gov) -  Aug 6, 2014
P2, N=12, Completed,  Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | N=400 --> 496 No longer recruiting --> Completed

||||||||||  dilanubicel (DVX101) / Deverra Therapeutics
Trial primary completion date:  Expanded Cord Blood Cell Infusion Following Combination Chemotherapy in Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) -  Jul 30, 2014
P=N/A, N=15, Recruiting,  Sponsor: Fred Hutchinson Cancer Research Center
No longer recruiting --> Completed Trial primary completion date: May 2014 --> May 2016

||||||||||  thioguanine / Generic mfg., melphalan / Generic mfg.
Trial completion:  Combination Chemotherapy Followed by Melphalan and Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Acute Myeloid Leukemia (clinicaltrials.gov) -  Jul 28, 2014
P1, N=35, Completed,  Sponsor: Children's Oncology Group
Trial primary completion date: May 2014 --> May 2016 Active, not recruiting --> Completed

||||||||||  cladribine / Generic mfg., idarubicin hydrochloride / Generic mfg.
Trial initiation date:  Chemotherapy in Treating Children With Recurrent Acute Myeloid Leukemia (clinicaltrials.gov) -  Jul 27, 2014
P2, N=120, Completed,  Sponsor: Children's Oncology Group
Active, not recruiting --> Completed Initiation date: Apr 2000 --> Mar 1998

||||||||||  topotecan / Generic mfg.
Trial completion, Enrollment change:  Chemotherapy in Treating Children With Relapsed Acute Leukemia, Acute Myeloid Leukemia, or Blastic Phase Chronic Myelogenous Leukemia (clinicaltrials.gov) -  Jul 24, 2014
P2, N=11, Completed,  Sponsor: Children's Oncology Group
Initiation date: Apr 2000 --> Mar 1998 Active, not recruiting --> Completed | N=50 --> 11

||||||||||  Intron A (interferon ?-2b) / Merck (MSD), Biogen, Roferon A (recombinant interferon alfa-2a) / Roche
Trial completion, Enrollment change:  Interferon Alfa in Treating Children With HIV-Related Cancer (clinicaltrials.gov) -  Jul 24, 2014
P2, N=8, Completed,  Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | N=50 --> 11 Active, not recruiting --> Completed | N=30 --> 8

||||||||||  Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Trial primary completion date:  Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Promyelocytic Leukemia (clinicaltrials.gov) -  Jul 23, 2014
P=N/A, N=30, Recruiting,  Sponsor: Comprehensive Cancer Center of Wake Forest University
Active, not recruiting --> Completed | N=30 --> 8 Trial primary completion date: Aug 2015 --> Aug 2020

||||||||||  cladribine / Generic mfg., idarubicin hydrochloride / Generic mfg.
Trial completion:  Chemotherapy in Treating Children With Recurrent Acute Myeloid Leukemia (clinicaltrials.gov) -  Jul 23, 2014
P2, N=120, Completed,  Sponsor: Children's Oncology Group
Trial primary completion date: Aug 2015 --> Aug 2020 No longer recruiting --> Completed

||||||||||  Campath (alemtuzumab) / Sanofi
Enrollment change:  Alemtuzumab, Fludarabine Phosphate, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer (clinicaltrials.gov) -  Jun 27, 2014
P2, N=11, Active, not recruiting,  Sponsor: Fred Hutchinson Cancer Research Center
No longer recruiting --> Completed N=100 --> 11

||||||||||  fludarabine IV / Generic mfg., cyclophosphamide / Generic mfg.
Trial primary completion date:  Fludarabine, Cyclophosphamide, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer (clinicaltrials.gov) -  Jun 19, 2014
P2, N=100, Active, not recruiting,  Sponsor: Sidney Kimmel Comprehensive Cancer Center
N=100 --> 11 Trial primary completion date: Dec 2014 --> Dec 2015

||||||||||  fludarabine IV / Generic mfg., busulfan / Generic mfg.
Trial primary completion date:  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) -  Jun 18, 2014
P2, N=70, Active, not recruiting,  Sponsor: UNC Lineberger Comprehensive Cancer Center
Trial primary completion date: Dec 2014 --> Dec 2015 Trial primary completion date: Dec 2013 --> Dec 2015

||||||||||  peripheral blood stem cell transplantation / National Cancer Institute
Trial termination:  Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer (clinicaltrials.gov) -  Jun 4, 2014
P2, N=48, Terminated,  Sponsor: Columbia University
Trial primary completion date: Dec 2013 --> Dec 2015 Recruiting --> Terminated; Poor enrollment

||||||||||  peripheral blood stem cell transplantation / National Cancer Institute
Trial initiation date:  Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer (clinicaltrials.gov) -  Jun 4, 2014
P2, N=48, Terminated,  Sponsor: Columbia University
Recruiting --> Terminated; Poor enrollment Initiation date: Jan 1997 --> Jul 1996

||||||||||  peripheral blood stem cell transplantation / National Cancer Institute
Enrollment change:  Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer (clinicaltrials.gov) -  Jun 4, 2014
P2, N=48, Terminated,  Sponsor: Columbia University
Initiation date: Jan 1997 --> Jul 1996 N=62 --> 48

|||||||||| Trial primary completion date: Total Marrow Irradiation for Refractory Acute Leukemia (clinicaltrials.gov) - May 14, 2014
P1, N=20, Recruiting, Sponsor: Masonic Cancer Center, University of Minnesota
N=62 --> 48 Trial primary completion date: Sep 2013 --> Sep 2017

|||||||||| Trial initiation date: Total Marrow Irradiation for Refractory Acute Leukemia (clinicaltrials.gov) - May 14, 2014
P1, N=20, Recruiting, Sponsor: Masonic Cancer Center, University of Minnesota
Trial primary completion date: Sep 2013 --> Sep 2017 Initiation date: Sep 2007 --> Aug 2012

||||||||||  bortezomib / Generic mfg.
Trial completion, IO biomarker:  Bortezomib and Combination Chemotherapy in Treating Younger Patients With Recurrent, Refractory, or Secondary Acute Myeloid Leukemia (clinicaltrials.gov) -  May 12, 2014
P2, N=52, Completed,  Sponsor: National Cancer Institute (NCI)
Initiation date: Sep 2007 --> Aug 2012 Active, not recruiting --> Completed

|||||||||| Trial completion: Prevention of Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation (clinicaltrials.gov) - May 4, 2014
P=N/A, N=0, Completed, Sponsor: Sidney Kimmel Comprehensive Cancer Center
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  obatoclax (GX 15-070) / Teva
Enrollment change, Combination therapy:  Obatoclax Mesylate, Vincristine Sulfate, Doxorubicin Hydrochloride, and Dexrazoxane Hydrochloride in Treating Young Patients With Relapsed or Refractory Solid Tumors, Lymphoma, or Leukemia (clinicaltrials.gov) -  Apr 29, 2014
P1, N=22, Terminated,  Sponsor: National Cancer Institute (NCI)
Active, not recruiting --> Completed N=52 --> 22

||||||||||  MK-2206 / Merck (MSD)
Enrollment change:  MK2206 in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Leukemia (clinicaltrials.gov) -  Apr 27, 2014
P1, N=45, Completed,  Sponsor: National Cancer Institute (NCI)
N=52 --> 22 N=96 --> 45

|||||||||| Enrollment change: Laboratory-Treated Donor Bone Marrow in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer (clinicaltrials.gov) - Apr 15, 2014
P3, N=72, Completed, Sponsor: Sidney Kimmel Comprehensive Cancer Center
N=96 --> 45 N=206 --> 72

||||||||||  arsenic trioxide / Generic mfg.
Trial completion:  Combination Chemotherapy in Treating Patients With Acute Promyelocytic Leukemia (clinicaltrials.gov) -  Apr 15, 2014
P2, N=0, Completed,  Sponsor: Sidney Kimmel Comprehensive Cancer Center
N=206 --> 72 Active, not recruiting --> Completed



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