Hemostatic Disorders News

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||||||||||  carfilzomib / Generic mfg.
P2 data:  Phase 2 Study of Carfilzomib in Relapsed and Refractory Multiple Myeloma (clinicaltrials.gov) -  Oct 10, 2013
P2, N=302, Completed,  Sponsor: Onyx Therapeutics, Inc.
Active, not recruiting --> Completed

||||||||||  Neupogen (filgrastim) / Kyowa Kirin, Amgen, plerixafor / Generic mfg.
Enrollment change:  Filgrastim With or Without Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide (clinicaltrials.gov) -  Oct 9, 2013
P3, N=9, Terminated,  Sponsor: Case Comprehensive Cancer Center
Active, not recruiting --> Completed N=90 --> 9

||||||||||  bortezomib / Generic mfg., lenalidomide / Generic mfg.
Enrollment open:  Lenalidomide After Donor Stem Cell Transplant and Bortezomib in Treating Patients With High Risk Multiple Myeloma (clinicaltrials.gov) -  Oct 9, 2013
P1, N=12, Recruiting,  Sponsor: Case Comprehensive Cancer Center
N=90 --> 9 Not yet recruiting --> Recruiting

||||||||||  Xyntha (moroctocog alfa) / Pfizer
New P4 trial:  Evaluation Of Acceptability And Satisfaction Of Hemophilia Patients Treated With FusENGO (clinicaltrials.gov) -  Oct 8, 2013
P4, N=200, Recruiting,  Sponsor: Pfizer

||||||||||  BeneFix (nonacog alfa) / Pfizer
Enrollment closed:  BeneFIX Drug Use Results Survey [All-Case Surveillance] (clinicaltrials.gov) -  Oct 7, 2013
P4, N=300, Active, not recruiting,  Sponsor: Pfizer
Not yet recruiting --> Recruiting Enrolling by invitation --> Active, not recruiting

||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Enrollment closed, Post-transplantation:  Rituximab in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant for Relapsed or Refractory B-cell Lymphoma (clinicaltrials.gov) -  Oct 7, 2013
P2, N=100, Active, not recruiting,  Sponsor: Fred Hutchinson Cancer Research Center
Enrolling by invitation --> Active, not recruiting Recruiting --> Active, not recruiting

||||||||||  Zarnestra (tipifarnib) / Kura Oncology
Trial termination:  Tipifarnib and Bortezomib in Treating Patients With Relapsed Multiple Myeloma (clinicaltrials.gov) -  Oct 6, 2013
P1/2, N=64, Terminated,  Sponsor: National Cancer Institute (NCI)
Recruiting --> Active, not recruiting Completed --> Terminated

||||||||||  bortezomib / Generic mfg., lenalidomide / Generic mfg.
New P1 trial:  Lenalidomide After Donor Stem Cell Transplant and Bortezomib in Treating Patients With High Risk Multiple Myeloma (clinicaltrials.gov) -  Oct 4, 2013
P1, N=12, Recruiting,  Sponsor: Case Comprehensive Cancer Center

||||||||||  bortezomib / Generic mfg.
Enrollment open:  Hemostatic Effects of VELCADE®* Treatment in Multiple Myeloma Patients (clinicaltrials.gov) -  Sep 29, 2013
P2, N=10, Recruiting,  Sponsor: University of Utah
Completed --> Terminated Not yet recruiting --> Recruiting

||||||||||  Decadron (dexamethasone) / Merck (MSD)
Trial completion, IO biomarker:  Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies (clinicaltrials.gov) -  Sep 29, 2013
P2, N=13, Completed,  Sponsor: Milton S. Hershey Medical Center
Not yet recruiting --> Recruiting Active, not recruiting --> Completed

||||||||||  Zelboraf (vemurafenib) / Roche
Trial completion:  A Screening Study to Detect BRAF V600 Mutation-Positive Patients For Enrollment Into Clinical Research Studies of Zelboraf (Vemurafenib) (clinicaltrials.gov) -  Sep 29, 2013
P=N/A, N=658, Completed,  Sponsor: Genentech
Active, not recruiting --> Completed Recruiting --> Completed

||||||||||  MK-2206 / Merck (MSD)
Trial completion:  MK2206 in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Leukemia (clinicaltrials.gov) -  Sep 26, 2013
P1, N=45, Completed,  Sponsor: National Cancer Institute (NCI)
Recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Sutent (sunitinib) / Pfizer
Trial completion:  Sunitinib Malate in Treating HIV-Positive Patients With Cancer Receiving Antiretroviral Therapy (clinicaltrials.gov) -  Sep 26, 2013
P1, N=42, Completed,  Sponsor: National Cancer Institute (NCI)
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Triapine (3-AP) / Vion, Northwestern University
Trial completion, Combination therapy, Metastases:  3-AP and Gemcitabine in Treating Patients With Advanced Solid Tumors or Lymphoma (clinicaltrials.gov) -  Sep 26, 2013
P1, N=30, Completed,  Sponsor: National Cancer Institute (NCI)
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  NovoSeven (eptacog alfa) / Novo Nordisk
New P1 trial:  A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors (clinicaltrials.gov) -  Sep 23, 2013
P1, N=6, Completed,  Sponsor: Novo Nordisk

||||||||||  letetresgene autoleucel (GSK3377794) / Adaptimmune
Enrollment open:  CT Antigen TCR-Engineered T Cells for Myeloma (clinicaltrials.gov) -  Sep 23, 2013
P1/2, N=10, Recruiting,  Sponsor: Adaptimmune
Active, not recruiting --> Completed Not yet recruiting --> Recruiting

||||||||||  carfilzomib / Generic mfg.
Clinical:  Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Multiple Myeloma and Renal Disease (clinicaltrials.gov) -  Sep 22, 2013
P1, N=32, Recruiting,  Sponsor: Onyx Therapeutics, Inc.

||||||||||  bortezomib / Generic mfg.
Enrollment closed:  UARK 2010-35, A Study of Expanded Natural Killer Cell Therapy for Multiple Myeloma (clinicaltrials.gov) -  Sep 19, 2013
P2, N=30, Active, not recruiting,  Sponsor: University of Arkansas
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting

||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Trial completion:  Treated T Cells Followed by a Stem Cell Transplant in Treating Patients With Multiple Myeloma (clinicaltrials.gov) -  Sep 19, 2013
P1, N=12, Completed,  Sponsor: Barbara Ann Karmanos Cancer Institute
Recruiting --> Active, not recruiting Active, not recruiting --> Completed

||||||||||  bortezomib / Generic mfg.
Trial completion:  Samarium 153 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) -  Sep 18, 2013
P1, N=36, Completed,  Sponsor: Oncotherapeutics
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Trial completion: Human Immune Globulin in Treating Patients With Primary Amyloidosis That is Causing Heart Dysfunction (clinicaltrials.gov) - Sep 15, 2013
P1/2, N=10, Completed, Sponsor: University of Tennessee
Active, not recruiting --> Completed Recruiting --> Completed

||||||||||  Rituxan (rituximab) / Roche
Enrollment change:  Irradiated Donor Lymphocytes and Rituximab in Treating Patients With Relapsed or Refractory Lymphoproliferative Disease (clinicaltrials.gov) -  Sep 12, 2013
P1, N=2, Terminated,  Sponsor: University of Medicine and Dentistry New Jersey
Recruiting --> Completed N=20 --> 2

||||||||||  Rituxan (rituximab) / Roche
Trial termination:  Lenalidomide With or Without Rituximab in Treating Patients With Progressive or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, or Non-Hodgkin Lymphoma Previously Treated With Donor Stem Cell Transplant (clinicaltrials.gov) -  Sep 10, 2013
P2, N=3, Terminated,  Sponsor: Fred Hutchinson Cancer Research Center
N=20 --> 2 Recruiting --> Terminated; Low accrual

||||||||||  Rituxan (rituximab) / Roche
Enrollment change:  Lenalidomide With or Without Rituximab in Treating Patients With Progressive or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, or Non-Hodgkin Lymphoma Previously Treated With Donor Stem Cell Transplant (clinicaltrials.gov) -  Sep 10, 2013
P2, N=3, Terminated,  Sponsor: Fred Hutchinson Cancer Research Center
Recruiting --> Terminated; Low accrual N=50 --> 3

|||||||||| Enrollment open: Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain (clinicaltrials.gov) - Sep 10, 2013
P1/2, N=52, Recruiting, Sponsor: H. Lee Moffitt Cancer Center and Research Institute
N=50 --> 3 Not yet recruiting --> Recruiting

|||||||||| Enrollment change: Study of Hyperbaric Oxygen Therapy in Addition to Standard Growth Factor Support for Hematopoietic Progenitor/Stem Cell Mobilization (clinicaltrials.gov) - Sep 8, 2013
P=N/A, N=8, Completed, Sponsor: University of Arkansas
Not yet recruiting --> Recruiting N=30 --> 8

|||||||||| Trial completion: Viscosupplementation in Patients With Hemophilic Arthropathy (clinicaltrials.gov) - Sep 8, 2013
P4, N=13, Completed, Sponsor: University of Sao Paulo General Hospital
N=30 --> 8 Active, not recruiting --> Completed

|||||||||| Trial completion: Study of Hyperbaric Oxygen Therapy in Addition to Standard Growth Factor Support for Hematopoietic Progenitor/Stem Cell Mobilization (clinicaltrials.gov) - Sep 8, 2013
P=N/A, N=8, Completed, Sponsor: University of Arkansas
Active, not recruiting --> Completed Recruiting --> Completed

|||||||||| Trial completion: Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy? (clinicaltrials.gov) - Sep 8, 2013
P=N/A, N=50, Completed, Sponsor: Copenhagen University Hospital at Herlev
Recruiting --> Completed Recruiting --> Completed

||||||||||  carfilzomib / Generic mfg.
Combination therapy:  Study of Carfilzomib in Combination w/Dexamethasone in Patients w/Newly Diagnosed Multiple Myeloma (clinicaltrials.gov) -  Sep 3, 2013
P2, N=55, Recruiting,  Sponsor: Emory University

||||||||||  bortezomib / Generic mfg., melphalan / Generic mfg.
New P1/2 trial:  Bortezomib, Melphalan, and Total-Body Irradiation Before Stem Cell Transplant in Treating Patients With Multiple Myeloma (clinicaltrials.gov) -  Sep 3, 2013
P1/2, N=69, Active, not recruiting,  Sponsor: Mayo Clinic

||||||||||  DI Leu16 IL-2 / Provenance, Alopexx, EMD Serono, Rituxan (rituximab) / Roche
Enrollment closed:  Fusion Protein Cytokine Therapy After Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) -  Sep 3, 2013
P1, N=36, Active, not recruiting,  Sponsor: City of Hope Medical Center
Recruiting --> Completed Recruiting --> Active, not recruiting

||||||||||  Ibrance (palbociclib) / Pfizer
Trial completion, Combination therapy:  An Investigational Drug, Palbociclib (PD-0332991), Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma. (clinicaltrials.gov) -  Sep 3, 2013
P1/2, N=53, Completed,  Sponsor: Pfizer
Recruiting --> Active, not recruiting Active, not recruiting --> Completed

||||||||||  delanzomib (CEP-18770) / Teva
Trial termination, Combination therapy:  Delanzomib (CEP-18770) in Combination With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) -  Aug 29, 2013
P1/2, N=11, Terminated,  Sponsor: Cephalon
Active, not recruiting --> Completed Active, not recruiting --> Terminated

|||||||||| Enrollment change: Study of Hypotensive Hematopoietic Malignancy Patients' USCOM Readings (clinicaltrials.gov) - Aug 29, 2013
P=N/A, N=69, Completed, Sponsor: Washington University School of Medicine
Active, not recruiting --> Terminated N=175 --> 69

||||||||||  delanzomib (CEP-18770) / Teva
Enrollment change, Combination therapy:  Delanzomib (CEP-18770) in Combination With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) -  Aug 29, 2013
P1/2, N=11, Terminated,  Sponsor: Cephalon
N=175 --> 69 N=85 --> 11

|||||||||| Trial completion: Study of Hypotensive Hematopoietic Malignancy Patients' USCOM Readings (clinicaltrials.gov) - Aug 29, 2013
P=N/A, N=69, Completed, Sponsor: Washington University School of Medicine
N=85 --> 11 Recruiting --> Completed

|||||||||| Enrollment open: Cognitive-Behavioral Intervention for Worry, Uncertainty, and Insomnia for Cancer Survivors (clinicaltrials.gov) - Aug 27, 2013
P=N/A, N=75, Recruiting, Sponsor: Ohio State University Comprehensive Cancer Center
Recruiting --> Completed Not yet recruiting --> Recruiting

||||||||||  IPH 2101 / Novo Nordisk, Innate
Trial completion:  KIRMONO: Study on the Anti-tumor Activity, Safety and Pharmacology of IPH2101 in Patients With Smoldering Multiple Myeloma (clinicaltrials.gov) -  Aug 27, 2013
P2, N=30, Completed,  Sponsor: Innate Pharma
Not yet recruiting --> Recruiting Active, not recruiting --> Completed

|||||||||| Trial termination, IO biomarker: SCRI Tissue Testing Registry (clinicaltrials.gov) - Aug 26, 2013
P=N/A, N=20, Terminated, Sponsor: SCRI Development Innovations, LLC
Active, not recruiting --> Completed Recruiting --> Terminated; Replaced by a study with a similar design.

||||||||||  Farydak (panobinostat) / Secura Bio
Enrollment change, Combination therapy:  MACS1271: Efficacy of Panobinostat in Patients With Relapsed and Bortezomib-refractory Multiple Myeloma (clinicaltrials.gov) -  Aug 26, 2013
P4, N=55, Active, not recruiting,  Sponsor: Novartis Pharmaceuticals
Recruiting --> Terminated; Replaced by a study with a similar design. N=76 --> 55

|||||||||| Enrollment change, IO biomarker: SCRI Tissue Testing Registry (clinicaltrials.gov) - Aug 26, 2013
P=N/A, N=20, Terminated, Sponsor: SCRI Development Innovations, LLC
N=76 --> 55 N=500 --> 20

||||||||||  dexamethasone / Generic mfg., bendamustine / Generic mfg., pomalidomide / Generic mfg.
Clinical:  Bendamustine + Pomalidomide + Dex in R/R Multiple Myeloma (clinicaltrials.gov) -  Aug 26, 2013
P1/2, N=56, Recruiting,  Sponsor: Cristina Gasparetto
N=500 --> 20 Not yet recruiting --> Recruiting

||||||||||  fludarabine IV / Generic mfg.
Trial completion:  Chlorambucil or Fludarabine as First-Line Therapy in Treating Patients With Previously Untreated Waldenstr (clinicaltrials.gov) -  Aug 22, 2013
P3, N=400, Completed,  Sponsor: Taunton and Somerset Hospital
Not yet recruiting --> Recruiting Recruiting --> Completed

||||||||||  dexamethasone / Generic mfg.
Trial completion:  CRUK-MERIT: Dexamethasone and Chemotherapy With or Without Plasma Exchange in Patients With Newly Diagnosed Multiple Myeloma and Acute Kidney Failure (clinicaltrials.gov) -  Aug 22, 2013
P3, N=280, Completed,  Sponsor: University of Glasgow
Recruiting --> Completed Recruiting --> Completed

||||||||||  Farydak (panobinostat) / Secura Bio
Enrollment open, Combination therapy:  Combination Therapy of Lenalidomide/Bortezomib/Dexamethasone and Panobinostat in Transplant Eligible New Diagnosed Multiple Myeloma (MM) Patients (clinicaltrials.gov) -  Aug 19, 2013
P1/2, N=38, Recruiting,  Sponsor: M.D. Anderson Cancer Center
Recruiting --> Completed Active, not recruiting --> Recruiting

|||||||||| Enrollment change: Internet-based Educational Program to Promote Self-Management for Teens With Hemophilia (clinicaltrials.gov) - Aug 18, 2013
P=N/A, N=29, Completed, Sponsor: The Hospital for Sick Children
Active, not recruiting --> Recruiting N=40 --> 29

|||||||||| Trial completion: Internet-based Educational Program to Promote Self-Management for Teens With Hemophilia (clinicaltrials.gov) - Aug 18, 2013
P=N/A, N=29, Completed, Sponsor: The Hospital for Sick Children
N=40 --> 29 Not yet recruiting --> Completed

||||||||||  melphalan / Generic mfg.
Enrollment closed:  Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Diseases (clinicaltrials.gov) -  Aug 14, 2013
P2, N=70, Active, not recruiting,  Sponsor: Comprehensive Cancer Center of Wake Forest University
Not yet recruiting --> Completed Recruiting --> Active, not recruiting

||||||||||  Kogenate FS (octocog alfa sucrose formulation) / CSL Behring, Bayer
Trial completion:  Kogenate FS Regulatory Post-Marketing Surveillance (clinicaltrials.gov) -  Aug 14, 2013
P=N/A, N=64, Completed,  Sponsor: Bayer
Recruiting --> Active, not recruiting Active, not recruiting --> Completed



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