Acute Myeloid Leukemia, Adult News

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||||||||||  vadastuximab talirine (SGN-CD33A) / Pfizer
Phase classification, Combination therapy:  A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML (clinicaltrials.gov) -  May 31, 2016
P1b, N=144, Recruiting,  Sponsor: Seattle Genetics, Inc.
Phase classification: P1 --> P1b

|||||||||| Trial primary completion date: Transfusional Iron Overload Among Leukemia Survivors (clinicaltrials.gov) - May 26, 2016
P=N/A, N=61, Recruiting, Sponsor: St. Jude Children's Research Hospital
Phase classification: P1 --> P1b Trial primary completion date: Nov 2016 --> Nov 2018

||||||||||  volasertib (NBL-001) / Oncoheroes, Notable Labs
Trial primary completion date, Combination therapy:  Volasertib + Decitabine in Patients With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) -  May 24, 2016
P1, N=127, Active, not recruiting,  Sponsor: Boehringer Ingelheim
Trial primary completion date: Nov 2016 --> Nov 2018 Trial primary completion date: Mar 2018 --> Jul 2018

||||||||||  cytarabine / Generic mfg.
Trial primary completion date:  Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior (clinicaltrials.gov) -  May 24, 2016
P2/3, N=40, Recruiting,  Sponsor: Sidney Kimmel Comprehensive Cancer Center
Trial primary completion date: Mar 2018 --> Jul 2018 Trial primary completion date: Aug 2016 --> Aug 2017

||||||||||  Mobista (CDX-301) / Celldex
Trial termination, IO biomarker:  A Safety and Tolerability Study of CDX-301 With or Without Plerixafor for Stem Cell Mobilization in Matched Related Allogeneic Donor/Recipient Sibling Transplant Pairs (clinicaltrials.gov) -  May 24, 2016
P2, N=36, Terminated,  Sponsor: Celldex Therapeutics
Trial primary completion date: Aug 2016 --> Aug 2017 Active, not recruiting --> Terminated

||||||||||  dilanubicel (DVX101) / Deverra Therapeutics
Trial completion:  Infusion of Off-the-Shelf Expanded Cord Blood Cells to Augment Cord Blood Transplant in Patients With Hematologic Malignancies (clinicaltrials.gov) -  May 23, 2016
P2, N=15, Completed,  Sponsor: Fred Hutchinson Cancer Research Center
Active, not recruiting --> Terminated Active, not recruiting --> Completed

|||||||||| Biomarker, Trial completion, Trial primary completion date, IO biomarker: Studying Biomarkers in Samples From Younger Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - May 19, 2016
P=N/A, N=20, Completed, Sponsor: Children's Oncology Group
Active, not recruiting --> Completed Recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

||||||||||  Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Biomarker, Trial completion, Trial primary completion date:  Study of Gemtuzumab Ozogamicin Therapy in DNA Samples From Patients With Acute Myeloid Leukemia Treated on COG-AAML0531 (clinicaltrials.gov) -  May 19, 2016
P=N/A, N=1000, Completed,  Sponsor: Children's Oncology Group
Recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

|||||||||| Trial completion, Trial primary completion date: Cell Samples From Patients With Leukemia (clinicaltrials.gov) - May 19, 2016
P=N/A, N=10, Completed, Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

|||||||||| Biomarker, Trial completion, Trial primary completion date: Biomarkers in Bone Marrow Samples From Young Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - May 19, 2016
P=N/A, N=20, Completed, Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

|||||||||| Biomarker, Trial completion, Trial primary completion date: Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - May 19, 2016
P=N/A, N=234, Completed, Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

|||||||||| Biomarker, Trial completion, Trial primary completion date: Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - May 19, 2016
P=N/A, N=32, Completed, Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

|||||||||| Biomarker, Trial completion, Trial primary completion date: Biomarkers in Bone Marrow Samples From Pediatric Patients With High-Risk Acute Myeloid Leukemia (clinicaltrials.gov) - May 19, 2016
P=N/A, N=250, Completed, Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

|||||||||| Trial primary completion date: Decitabine Followed by Mitoxantrone Hydrochloride, Etoposide, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes (clinicaltrials.gov) - May 19, 2016
P1/2, N=52, Recruiting, Sponsor: Fred Hutchinson Cancer Research Center
Recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Trial primary completion date: Jun 2016 --> Dec 2016

||||||||||  lenalidomide / Generic mfg.
Enrollment change:  Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia. (clinicaltrials.gov) -  May 19, 2016
P1, N=37, Active, not recruiting,  Sponsor: Leslie Andritsos
Trial primary completion date: Jun 2016 --> Dec 2016 N=84 --> 37

|||||||||| Trial completion, Trial primary completion date: Studying Genes in Samples From Younger Patients With Acute Megakaryoblastic Leukemia (clinicaltrials.gov) - May 19, 2016
P=N/A, N=100, Completed, Sponsor: Children's Oncology Group
N=84 --> 37 Recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

||||||||||  Vanflyta (quizartinib) / Daiichi Sankyo
Trial completion, Trial primary completion date:  Developing and Treating a Mouse Model of Acute Myeloid Leukemia Using Tissue Samples From Younger Patients With Acute Myeloid Leukemia (clinicaltrials.gov) -  May 19, 2016
P=N/A, N=10, Completed,  Sponsor: Children's Oncology Group
Recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

|||||||||| Biomarker, Trial completion, Trial primary completion date: Studying Biomarker Expression in Samples From Patients With Down Syndrome and Acute Myeloid Leukemia or Other Transient Myeloproliferative Disorder (clinicaltrials.gov) - May 19, 2016
P=N/A, N=60, Completed, Sponsor: Children's Oncology Group
Recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

|||||||||| Trial completion, Trial primary completion date: Studying DNA in Samples From Younger Patients With Down Syndrome and Acute Myeloid Leukemia Treated on COG-AAML0431 Clinical Trial (clinicaltrials.gov) - May 19, 2016
P=N/A, N=10, Completed, Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

|||||||||| Biomarker, Trial completion, Trial primary completion date: Role of Biomarkers in Disease Progression in Samples From Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - May 19, 2016
P=N/A, N=20, Completed, Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

|||||||||| Trial completion, Trial primary completion date: Study to Predict Risk of Relapse in Bone Marrow Cell Samples From Younger Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - May 19, 2016
P=N/A, N=98, Completed, Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

|||||||||| Trial completion, Trial primary completion date: Study of Proteins in Promoting Chemotherapy Resistance in Samples From Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - May 19, 2016
P=N/A, N=40, Completed, Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

|||||||||| Biomarker, Trial completion, Trial primary completion date: Biomarkers in Predicting Response to Treatment in Bone Marrow Samples From Young Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - May 19, 2016
P=N/A, N=97, Completed, Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

|||||||||| Biomarker, Trial completion, Trial primary completion date: Biomarkers in Samples of Bone Marrow From Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - May 19, 2016
P=N/A, N=9, Completed, Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> Jan 2015

|||||||||| Biomarker, Trial completion, Trial initiation date, Trial primary completion date: Prognostic Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - May 19, 2016
P=N/A, N=150, Completed, Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> Jan 2015 Active, not recruiting --> Completed | Initiation date: Nov 2010 --> May 2010 | Trial primary completion date: Jan 2100 --> May 2016

|||||||||| Biomarker, Trial completion, Trial primary completion date: RNA Biomarkers in Tissue Samples From Infants With Acute Myeloid Leukemia (clinicaltrials.gov) - May 19, 2016
P=N/A, N=20, Completed, Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | Initiation date: Nov 2010 --> May 2010 | Trial primary completion date: Jan 2100 --> May 2016 Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

||||||||||  lestaurtinib (CEP-701) / Teva, Kyowa Kirin
Trial completion, Trial primary completion date:  Lestaurtinib With or Without Chemotherapy Agents in Samples From Young Patients With Leukemia (clinicaltrials.gov) -  May 19, 2016
P=N/A, N=18, Completed,  Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

||||||||||  obatoclax (GX 15-070) / Teva
Trial completion, Trial primary completion date:  Obatoclax Mesylate in Samples From Young Patients With Acute Myeloid Leukemia (clinicaltrials.gov) -  May 19, 2016
P=N/A, N=50, Completed,  Sponsor: Children's Oncology Group
Recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

|||||||||| Trial completion, Trial initiation date, Trial primary completion date: Identification of de Novo Fanconi Anemia in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia (clinicaltrials.gov) - May 19, 2016
P=N/A, N=20, Completed, Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Recruiting --> Completed | Initiation date: Oct 2009 --> May 2009 | Trial primary completion date: Jan 2100 --> May 2016

|||||||||| Biomarker, Trial completion, Trial primary completion date: Biomarker Changes in Samples From Young Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - May 19, 2016
P=N/A, N=15, Completed, Sponsor: Children's Oncology Group
Recruiting --> Completed | Initiation date: Oct 2009 --> May 2009 | Trial primary completion date: Jan 2100 --> May 2016 Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

|||||||||| Trial completion, Trial primary completion date: Blood and Tumor Tissue Samples From Young Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - May 19, 2016
P=N/A, N=52, Completed, Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

||||||||||  Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Biomarker, Trial completion, Trial primary completion date:  Biomarkers in DNA Samples From Younger Patients With Newly Diagnosed Acute Myeloid Leukemia Receiving Gemtuzumab Ozogamicin (clinicaltrials.gov) -  May 19, 2016
P=N/A, N=300, Completed,  Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

|||||||||| Biomarker, Trial completion, Trial primary completion date: Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - May 19, 2016
P=N/A, N=149, Completed, Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

|||||||||| Biomarker, Trial completion, Trial primary completion date: Studying Biomarkers in Cell Samples From Young Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - May 19, 2016
P=N/A, N=75, Completed, Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

|||||||||| Biomarker, Trial completion, 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 19, 2016
P=N/A, N=90, Completed, Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

|||||||||| Trial completion, Trial primary completion date: Studying DNA in Blood and Bone Marrow Samples From Younger Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - May 19, 2016
P=N/A, N=2500, Completed, Sponsor: Children's Oncology Group
Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016

||||||||||  Grafalon (rabbit anti-T-lymphocyte globulin) / Mundipharma, NeoPharm
Trial primary completion date:  Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD) (clinicaltrials.gov) -  May 16, 2016
P3, N=260, Active, not recruiting,  Sponsor: Neovii Biotech
Active, not recruiting --> Completed | Trial primary completion date: Jan 2100 --> May 2016 Trial primary completion date: Feb 2016 --> Sep 2016

|||||||||| Enrollment closed, Trial primary completion date: Red Cell Transfusion Goals in Patients With Acute Leukemias (clinicaltrials.gov) - May 13, 2016
P0, N=90, Active, not recruiting, Sponsor: Sidney Kimmel Comprehensive Cancer Center
Trial primary completion date: Feb 2016 --> Sep 2016 Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2015 --> Aug 2016

||||||||||  Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Trial completion, Trial primary completion date:  NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia (clinicaltrials.gov) -  May 13, 2016
P3, N=250, Completed,  Sponsor: University of Aarhus
Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2015 --> Aug 2016 Active, not recruiting --> Completed | Trial primary completion date: Jan 2014 --> Jan 2012

|||||||||| Trial primary completion date: Immune Response After Stem Cell Transplant in HIV-Positive Patients With Hematologic Cancer (clinicaltrials.gov) - May 13, 2016
P2, N=10, Recruiting, Sponsor: Fred Hutchinson Cancer Research Center
Active, not recruiting --> Completed | Trial primary completion date: Jan 2014 --> Jan 2012 Trial primary completion date: Sep 2016 --> Mar 2017

||||||||||  cytarabine / Generic mfg.
Trial primary completion date:  Sequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse AML (clinicaltrials.gov) -  May 10, 2016
P2, N=42, Recruiting,  Sponsor: Shanghai Jiao Tong University School of Medicine
Trial primary completion date: Sep 2016 --> Mar 2017 Trial primary completion date: Dec 2015 --> Dec 2017

||||||||||  GSK2130579A / GSK
Trial completion, Trial primary completion date:  Evaluation of a New Anti-cancer Immunotherapy in Adult Acute Myeloid Leukemia Patients With a Suboptimal Clinical Response to Induction Chemotherapy (clinicaltrials.gov) -  May 9, 2016
P1, N=17, Completed,  Sponsor: GlaxoSmithKline
Trial primary completion date: Dec 2015 --> Dec 2017 Active, not recruiting --> Completed | Trial primary completion date: Aug 2017 --> Apr 2016

||||||||||  Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
Trial completion:  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) -  May 6, 2016
P2, N=23, Completed,  Sponsor: Fred Hutchinson Cancer Research Center
Active, not recruiting --> Completed | Trial primary completion date: Aug 2017 --> Apr 2016 Active, not recruiting --> Completed

||||||||||  BI 836858 / Boehringer Ingelheim
Trial primary completion date:  BI 836858 Dose Escalation in Patients With Refractory or Relapsed Acute Myeloid Leukemia and in Patients in Complete Remission With High Risk to Relapse (clinicaltrials.gov) -  May 4, 2016
P1, N=36, Recruiting,  Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed Trial primary completion date: Apr 2016 --> Oct 2016

||||||||||  Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
Enrollment open:  Cord Blood Fucosylation to Enhance Homing and Engraftment in Patients With Hematologic Malignancies (clinicaltrials.gov) -  May 4, 2016
P1, N=50, Recruiting,  Sponsor: M.D. Anderson Cancer Center
Trial primary completion date: Apr 2016 --> Oct 2016 Active, not recruiting --> Recruiting

|||||||||| Trial termination: Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation (clinicaltrials.gov) - May 2, 2016
P2, N=12, Terminated, Sponsor: St. Jude Children's Research Hospital
Active, not recruiting --> Recruiting Active, not recruiting --> Terminated; Investigator's decision.

||||||||||  Vyxeos (cytarabine/daunorubicin liposomal formulation) / Jazz, Nippon Shinyaku
Trial primary completion date:  Liposomal Cytarabine-Daunorubicin CPX-351 in Treating Patients With Untreated Myelodysplastic Syndrome or Acute Myeloid Leukemia (clinicaltrials.gov) -  Apr 28, 2016
P=N/A, N=90, Recruiting,  Sponsor: Fred Hutchinson Cancer Research Center
Active, not recruiting --> Terminated; Investigator's decision. Trial primary completion date: Jun 2016 --> Dec 2016

|||||||||| Enrollment closed: Lenalidomide and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - Apr 27, 2016
P1, N=30, Active, not recruiting, Sponsor: Stanford University
Trial primary completion date: Jun 2016 --> Dec 2016 Suspended --> Active, not recruiting

||||||||||  Rydapt (midostaurin) / Novartis
Enrollment closed, Combination therapy:  Decitabine and Midostaurin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia (clinicaltrials.gov) -  Apr 27, 2016
P2, N=36, Active, not recruiting,  Sponsor: Bruno C. Medeiros
Suspended --> Active, not recruiting Suspended --> Active, not recruiting

||||||||||  Xospata (gilteritinib) / Astellas
Enrollment closed, Trial primary completion date:  Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of ASP2215 in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) -  Apr 27, 2016
P1, N=36, Active, not recruiting,  Sponsor: Astellas Pharma Inc
Suspended --> Active, not recruiting Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2015 --> Jun 2016



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