Clinical Trials

CLINICAL TRIALS: Hematology & Oncology

ECOG = Eastern Cooperative Oncology Group – one of the largest clinical cancer research organizations in the U.S., funded primarily by NIH’s National Cancer Institute

Thao Dang, PI

Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC) (ECOG)
Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511, IND #74019) as Maintenance Therapy in Non-Progressing Patients following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB/IV Non-Small Cell Lung Cancer (C30607) (ECOG)

Patrick Dillon, PI

Phase II Study of Dovitinib (TKI258) in Patients with Recurrent or Metastatic Adenoid Cystic Carcinoma (“Dovitinib ACC”) (Novartis Corporation)
The BEACON Study (Breast Cancer Outcomes with NKTR-102): A Phase III open label, randomized, multicenter study of NKTR-102 versus treatment of physician’s choice (TPC) in patients with locally recurrent or metastatic breast cancer previously treated with an anthracycline, a taxane, and capecitabine (Nektar Therapeutics Corporation)
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less (ECOG)

Michael Douvas, PI

Single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) (Novartis Corporation)
Detecting and Monitoring Hematologic Malignancies Through a New Molecular Method Named Anchored ChromPET (Chromosomal Paired End Tags) (UVA)

Michael Williams, PI

A Phase II Study to Assess the Efficacy and Safety of CAL-101 in Patients with Indolent B-Cell Non-Hodgkin Lymphoma Refractory to Rituximab and Alkylating Agents (Calistoga Pharmaceuticals)
Phase II, multicenter, single arm study to evaluate the efficacy and safety of single agent Bruton’s Tyrosine Kinase (BTK) inhibitor, Ibrutinib, in subjects with mantle cell lymphoma who progress after bortezomib therapy (Janssen Research & Development)
The National LymphoCare Study: An observational study of treatment, outcomes and prognosis in patients with follicular non-Hodgkin’s lymphoma (Genentech, Inc.)
Randomized Phase II Trial to Compare the Efficacy of Two Doses of Fostamatinib Disodium in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (Astra-Zeneca)
Randomized, Multicenter, Open-label, Phase III Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor Ibrutinib versus Ofatumumab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (Pharmacyclics, Inc.)

Geoffrey Weiss, PI

An open-label, randomized, multi-center, Phase III study to compare the safety and efficacy of TKI258 versus sorafenib in patients with metastatic renal cell carcinoma after failure of anti-angiogenic (VEGF-targeted and mTOR inhibitor) therapies (Novartis Corporation)
A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics and Immunoregulatory Activity of BMS-663513 (Anti-CD137) in Subjects with Advanced and/or Metastatic Solid Tumors; CA186-011 (Bristol-Myers Sqibb)
A Phase I, open label, dose escalation, safety and pharmacokinetic study of CDS-1127 in patients with selected refractory or relapsed hematologic malignancies or solid tumors (Celldex)

Amer Beitinjaneh, PI

Phase II Trial of Reduced Intensity Conditioning (RIC) and Allogeneic Transplantation of Umbilical Cord Blood (UCB) from Unrelated Donors in Patients with Hematologic Malignancies (Investigator Initiated; UCB-2011)
DEFLECT-1: A Phase 3b Multi-Center, Double-Blind, Randomized, Placebo Controlled Study to Demonstrate the Safety and Efficacy of Fidaxomicin for Prophylaxis against Clostridium difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (Optimer Pharmaceuticals)

OTHER STUDIES: Hematology & Oncology

Tamila Kindwall-Keller, PI

Protocol for a Research Database for Hematopoietic Cell Transplantation, other Cellular Therapies and Marrow Toxic Injuries (National Marrow Donor Program and Center for International Blood and Marrow Transplant Research)
A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications (National Marrow Donor Program)
A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients (National Cord Blood Program)
Retrospective Evaluation of Outcomes in Umbilical Cord Blood Transplants Using the Fludarabine Busulfan Reduced Intensity Conditioning (Investigator initiated)