Hematologic Malignancies
MBRCC Open Clinical Trials List – December 2014 Hematologic Malignancies Leukemia Acute Leukemia ALL-Acute Lymphoblastic Leukemia Relapsed or Refractory –Phase 3 B1931022 - An Open-label, Randomized Phase 3 Study of Inotuzumab Ozogamicin Compared to a Defined Investigator's Choice in Adult Patients with Relapsed or Refractory CD22-Positive Acute Lymphoblastic Leukemia (ALL) Michael Craig, MD; Trish Beal, RN AML-Acute Myeloid Leukemia 1st line - Phase 3 E2906 - Phase III trial of Clofarabine as induction and post-remission therapy vs. standard daunorubicin & cytarabine post-remission therapy, followed by decitabine maintenance vs. observation in newly-diagnosed Acute Myeloid Leukemia in older adults (age greater than or equal to 60 years) Michael Craig, MD; Trish Beal, RN Phase 2 CASE1908 - A Phase I/II Study of Midostaruin(PKC412) and 5-Azaacitidine for Elderly Patients with AML Michael Craig, MD; Crystal Street, MT Chronic Leukemia CLL- Chronic Lymphocytic Leukemia 1st Line – Phase 3 E1912 - A Randomized Phase III Study of Ibrutinib based Therapy Versus Standard Fludarabine, Cyclophosphamide and Rituxan Chemoimmunotherapy in Untreated Younger Patients with CLL Abraham Kanate, MD; Sylvia McEwuen, RN 8 MBRCC Clinical Trials: http://www.hsc.wvu.edu/mbrcc/sip/ MBRCC Open Clinical Trials List – December 2014 A041202 - A Randomized Phase III Study of Bendamustine Plus Rituximab versus ibrutinib Plus Rituximab versus Ibrutinib Alone in Untreated Older Patients greater than or equal to 65 years of age with Chronic Lymphocytic Leukemia Michael Craig, MD; Sylvia McEwuen, RN CML- Chronic Myeloid Leukemia Phase 2 CAMN107AUS37 - A Phase II Randomized, Multicenter Study of Treatment-Free Remission In Chronic Myeloid Leukemia in Chronic Phase (CMP-CP) Patients who Achieve and Sustain MR4.5 After Switching to Nilotinib Abraham Kanate, MD; Trish Beal, RN Lymphoma B cell Lymphoma Diffuse Large B-Cell Lymphoma Relapsed – Refractory Phase 2 MI-CP204 - An Open-label, Phase 1/2 Study of MEDI-551, a Humanized Monoclonal Antibody Directed Against CD 19, in Adult Subjects with Relapsed or Refractory Advanced B-cell Malignancies Michael Craig, MD; Sylvia McEwuen, RN MEDI-551-1088 - A Phase 2 Randomized Open-Label Study of MEDI-551 in Adults with Relapsed or Refractory DLBCL Michael Craig, MD; Crystal Street, MT WVU11310 - Once daily intravenous Busulfex as part of reduced toxicity conditioning for patients with relapsed/refractory Hodgkin and nonHodgkin lymphomas undergoing allogeneic hematopoietic cell transplantation - A multicenter phase II study Abraham Kanate, MD; Crystal Street, MT Limited stage – Phase 2 S1001- A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-Cell Lymphoma Abraham Kanate, MD; Sylvia McEwuen, RN 9 MBRCC Clinical Trials: http://www.hsc.wvu.edu/mbrcc/sip/ MBRCC Open Clinical Trials List – December 2014 Mantle Cell Lymphoma 1st line – Phase 2 ECOG 1411 - Intergroup Randomized, Phase II Four Arm Study in Patients > or equal to 60 with Previously Untreated Mantle Cell Lymphoma with Therapy of Arm A Rituximab+Bendamustine Followed by Rituximab Consolidation; Arm B Ritiximab+Bendamustine+ Bortezomib Followed by Rituximab Consolidation; Arm C Rituximab+ Bendamustine Followed by Lenolidomide+ Rituximab Consolidation or Arm D Rituximab+ Bendamustine+Bortezomib followed by Lenolidomide and Rituximab consolidation Abraham Kanate, MD; Sylvia McEwuen, RN Other Phase 1 OMB113603 - An Open-Label Phase I drug-drug interaction study of ofatumumab with bendamustine for the treatment of subjects with indolent BCell Non-Hodgkin's Lymphoma Abraham Kanate, MD; Sylvia McEwuen, RN Follicular Lymphoma 1st line – Phase 2 CALGB50904 - A Randomized Phase II Trial of Ofatumumab and Bendamustine versus Ofatumumab, Bortezomib and Bendamustine in Patients with Untreated Follicular Lymphoma Michael Craig, MD; Sylvia McEwuen, RN Relapsed – Refractory - Phase 3 CC5013-NHL-008 - A Phase III Randomized Study of Lenalidomide Plus Rituximab Maintenance Therapy Followed By Lenalidomide Single-Agent Maintenance versus Rituximab Maintenance in Subjects with Relapsed refractory Follicular, Marginal Zone or Mantle Cell Lymphoma Michael Craig, MD; Sylvia McEwuen, RN T cell Lymphoma Relapsed – Refractory - Phase 2 WVU11310 - Once daily intravenous Busulfex as part of reduced toxicity conditioning for patients with relapsed/refractory Hodgkin and nonHodgkin lymphomas undergoing allogeneic hematopoietic cell transplantation - A multicenter phase II study Abraham Kanate, MD; Crystal Street, MT 10 MBRCC Clinical Trials: http://www.hsc.wvu.edu/mbrcc/sip/ MBRCC Open Clinical Trials List – December 2014 Hodgkin’s Lymphoma Frontline – Phase 3 C25003 - A Randomized, Open-Label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma Abraham Kanate, MD; Sylvia McEwuen, RN Relapsed – Refractory – Phase 2 WVU11310 - Once daily intravenous Busulfex as part of reduced toxicity conditioning for patients with relapsed/refractory Hodgkin and nonHodgkin lymphomas undergoing allogeneic hematopoietic cell transplantation - A multicenter phase II study Abraham Kanate, MD; Crystal Street, MT Multiple Myeloma Relapsed/Refractory Phase 2 ARRAY-520-216 - A Multicenter, Randomized, Open-label, Phase 2 Study of Carfilzomib With or Without ARRY-520 in Patients With Advanced Multiple Myeloma Michael Craig, MD; Trish Beal, RN Phase 3 CC-4047-MM-007 - A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Pomalidomide (POM), Bortezomib (BTZ) and Low-Dose Dexamethasone (LD-DEX) versus Bortezomib and Low-Dose Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma (MM) Abraham Kanate, MD; Trish Beal, RN Other 20090482 - A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Disease in Subjects with Newly Diagnosed Multiple Myeloma Abraham Kanate, MD; Trish Beal, RN PRE1003 - A Phase I/II Study of the Tolerability of Lenalidomide and Low Dose Dexamethasone in Previously Treated Multiple Myeloma Patients with Impaired Renal Function Abraham Kanate, MD; Trish Beal, RN Connect MM - The Multiple Myeloma Disease Registry Michael Craig, MD; Trish Beal, RN 11 MBRCC Clinical Trials: http://www.hsc.wvu.edu/mbrcc/sip/ MBRCC Open Clinical Trials List – December 2014 Transplant 1st line - Phase 3 BMTCTN1101- A Multi-Center, Phase III, Randomized Trial of Reduced Intensity (RIC) Conditioning and Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) versus HLA-Haploidentical Related Bone Marrow (haplo-BM) for Patients with Hematologic Malignancies Michael Craig, MD; Pam Bunner, CCRC Relapsed – Refractory – Phase 2 WVU11310 - Once daily intravenous Busulfex as part of reduced toxicity conditioning for patients with relapsed/refractory Hodgkin and nonHodgkin lymphomas undergoing allogeneic hematopoietic cell transplantation - A multicenter phase II study Abraham Kanate, MD; Crystal Street, MT Other 09-PLEX - Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor for the Mobilization and Transplantation of HLA-Matched Sibling Donor Hematopoietic Stem Cells in Recipients with Hematological Malignancies Michael Craig, MD; Crystal Street, MT BMTCTN1102 - A Multi-Center Biologic Assignment Trial Comparing Reduced Intensity Allogeneic Hematopoietic Cell Transplant to Hypomethylating Therapy or Best Supportive Care in Patients Age 50 or Older with Intermediate-2 and High Risk Myelodysplastic Syndrome Michael Craig, MD; Pam Bunner, CCRC WVU011012 - Phase II study of Atorvastatin, micro-dose methotrexate and tacrolimus administered only to transplant recipients for the prophylaxis of acute graft-versus-host disease following allogeneic hematopoietic cell transplantation; Michael Craig, MD; Pam Bunner, CCRC WVU1909 - Unrelated Umbilical Cord Blood (UBC) Transplantation Michael Craig, MD; Pam Bunner, CCRC Hematology Low or Intermediate 1 Risk MDS and Symptomatic Anemia E2905 - Randomized Phase III Trial Comparing the frequency of Major Erythroid Response to Treatment with Lenolidomide Alone and in Combination with Epoetin Alfa in Subjects with Low or Intermediate 1 Risk MDS and Symptomatic Anemia Michael Craig, MD; Trish Beal, RN 12 MBRCC Clinical Trials: http://www.hsc.wvu.edu/mbrcc/sip/ MBRCC Open Clinical Trials List – December 2014 Supportive Care DEFIBROTIDE2006-05 - Defibrotide for Patients with Hepatic Veno-Occlusive Disease (VOD): A Treatment IND Study (Under CRF 312.34) Michael Craig, MD; Pam Bunner, CCRC WVU041011- Treatment of Severe Mucositis Pain with Oral Ketamine Mouthwash Aaron Cumpston, PharmD; Pam Bunner, CCRC Other WVU021112 - Effect of Body Mass on Filgrastim Pharmacokinetics Aaron Cumpston, PharmD; Pam Bunner, CCRC WVU011112 - Validation of a Novel Marker Associated with Risk for Delayed Chemotherapy-induced Vomiting (CIV) (NHL) Gerald Higa, PharmD; Karen Stauffer, RN Contacts Principal Investigators Email Phone Mohammed Almubarak, MD 304-293-4229 Gerald Higa, PharmD malmubarak@hsc.wvu.edu skbasu@hsc.wvu.edu craigm@wvuhealthcare.com askanate@hsc.wvu.edu cumpstona@wvuhealthcare.com ghiga@hsc.wvu.edu Study Coordinators Email Phone Trish Beal, RN pbeal@hsc.wvu.edu bunnerp@wvuhealthcare.com smcewuen@hsc.wvu.edu ksstauffer@hsc.wvu.edu streetc@wvuhealthcare.com 304-293-0609 Soumit Basu, MD Michael Craig, MD Abraham Kanate, MD Aaron Cumpston, PharmD Pam Bunner, CCRC Sylvia McEwuen, RN Karen Stauffer, RN Crystal Street, MT 304-293-4229 304-293-4229 304-293-4229 304-598-4000 x73350 304-293-1461 304-598-4511 304-293-1683 304-581-1156 304-598-4512 13 MBRCC Clinical Trials: http://www.hsc.wvu.edu/mbrcc/sip/
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