Selected Protocols for the Treatment of Hematologic Malignancies in Adults Applicable Disease(s)/Treatment(s) Study Name Principal Investigator LEUKEMIA Acute T-cell Lymphoblastic Leukemia •Relapsed/Refractory T-cell Lymphoblastic Lymphoma •Relapsed/Refractory Study to evaluate the safety and tolerability of weekly intravenous doses of BMS-906024 in patients with acute T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma Protocol # 11-290 Daniel DeAngelo, MD, PhD 617-632-2645 daniel_deangelo@dfci.harvard.edu LEUKEMIA Myelodysplastic Syndromes Phase I/II pharmacokinetic guided dose-escalation and doseconfirmation study of ASTX727, a combination of the oral cytidine deaminase inhibitor (CDAi) E7727 with oral decitabine in patients with myelodysplastic syndromes (MDS) Protocol # 14-195 David Steensma, MD 617-632-5202 david_steensma@dfci.harvard.edu LEUKEMIA Myeloproliferative Disorders Myelofibrosis Phase I/II open-label, dose-escalation, multi-center study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered NS-018 in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis, or postessential thrombocythemia myelofibrosis Protocol # 13-109 Martha Wadleigh, MD 617-632-3712 martha_wadleigh@dfci.harvard.edu LEUKEMIA Chronic Myelogenous Leukemia Acute Lymphoblastic Leukemia Phase I, multi-center, open-label study of oral ABL001 in patients with chronic myelogenous leukemia or Philadelphia Chromosomepositive acute lymphoblastic leukemia Protocol # 14-117 Daniel DeAngelo, MD, PhD 617-632-2645 daniel_deangelo@dfci.harvard.edu LEUKEMIA Acute Myeloid Leukemia Myelodysplastic Syndromes Phase I, multi-center, open-Label, dose-escalation, safety, pharmacokinetic, pharmacodynamic, and clinical activity study of orally- administered AG-120 in patients with advanced hematologic malignancies with an IDH1 mutation Protocol # 12-288 Richard Stone, MD 617-632-1906 richard_stone@dfci.harvard.edu LEUKEMIA Hairy Cell Leukemia Phase II study of BRAF inhibitor, Vemurafenib, in patients with relapsed or refractory hairy cell leukemia Protocol # 13-352 Richard Stone, MD 617-632-1906 richard_stone@dfci.harvard.edu LYMPHOMA Hodgkin Lymphoma Phase 2 Study of Nivolumab (anti-PD1 antibody) in Hodgkin Lymphoma Protocol #14-242 Philippe Armand, MD, PhD 617-632-2305 philippe_armand@dfci.harvard.edu LYMPHOMA Diffuse Large B-Cell Lymphoma Phase 2 Study of Nivolumab (Anti-PD1 Antibody) in Diffuse Large B-Cell Lymphoma Protocol #14-157 Philippe Armand, MD, PhD 617-632-2305 philippe_armand@dfci.harvard.edu LYMPHOMA Follicular Lymphoma Phase 2 Study of Nivolumab (Anti-PD1 Antibody) in Follicular Lymphoma Protocol #14-159 Philippe Armand, MD, PhD 617-632-2305 philippe_armand@dfci.harvard.edu Winter 2014 www.dfbwcc.org/clinicaltrials Selected Protocols for the Treatment of Hematologic Malignancies in Adults Applicable Disease(s)/Treatment(s) Study Name Principal Investigator CHRONIC LYMPHOCYTIC LEUKEMIA • No Prior Therapy Idelalisib-Ofatumumab for Untreated Patients Protocol #13-309 Jennifer R. Brown, MD, PhD 617-632-4564 jennifer_brown@dfci.harvard.edu CHRONIC LYMPHOCYTIC LEUKEMIA • No Prior Therapy Ibrutinib-FCR for Untreated Patients Protocol #14-296 Matthew Davids, MD 617-632-1906 matthew_davids@dfci.harvard.edu CHRONIC LYMPHOCYTIC LEUKEMIA • Relapsed Ibrutinib-TGR PI3K Inhibitor for Relapsed Patients Protocol #14-396 Matthew Davids, MD 617-632-6331 matthew_davids@dfci.harvard.edu CHRONIC LYMPHOCYTIC LEUKEMIA LYMPHOMA Phase 1 Study of Anti-LAG3 Antibody in Lymphoma and CLL Protocol #14-072 Philippe Armand, MD, PhD 617-632-2305 philippe_armand@dfci.harvard.edu LYMPHOMA Hodgkin Lymphoma Non-Hodgkin Lymphoma Phase 1 Combination Study of Nivolumab (Anti-PD1 Antibody) and Ipilimumab (Anti-CTLA4 Antibody) in Hodgkin and Non-Hodgkin Lymphoma Protocol #12-317 Philippe Armand, MD, PhD 617-632-2305 philippe_armand@dfci.harvard.edu MULTIPLE MYELOMA •Newly Diagnosed Randomized trial of lenalidomide, bortezomib, dexamethasone versus high-dose treatment with stem cell transplantation in multiple myeloma patients up to age 65. Protocol # 10-106 Paul Richardson, MD 617-632-2104 paul_richardson@dfci.harvard.edu MULTIPLE MYELOMA •Relapsed /Refractory Open-label study of TH-302 and dexamethasone with or without bortezomib in patients with relapsed/refractory multiple myeloma. Protocol # 11-425 Irene Ghobrial, MD 617-632-2127 irene_ghobrial@dfci.harvard.edu MULTIPLE MYELOMA •Relapsed /Refractory A Phase I/II Study of Pomalidomide, Dexamethasone and MLN9708 vs. Pomalidomide and Dexamethasone for Patients with Multiple Myeloma Refractory to Lenalidomide and Proteasome Inhibitor-Based Therapy. Protocol# 14-334 Claudia-Paba Prada, MD 617-632-4198 claudiap_prada@dfci.harvard.edu MULTIPLE MYELOMA •Relapsed /Refractory A Phase I, Multicenter, Open-label, Combination Study of Pomalidomide, Marizomib, and Low-Dose Dexamethasone (PMD) in patients w/ Relapsed or Refratory Multiple Myeoma. Protocol# 14-028 Jacob Laubach, MD 617-582-7102 jacob_laubach@dfci.harvard.edu MULTIPLE MYELOMA •Relapsed /Refractory Phase Ib/2, Multi-center, Open Label Study of Oprozomib and Dexamethasone and/or Refractory Multiple Myeoma. Protocol# 13-362 Claudia-Paba Prada, MD 617-632-4198 claudiap_prada@dfci.harvard.edu MULTIPLE MYELOMA • Relapsed / Refractory A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Pomalidomide (POM), Bortezomib (BTZ) andLow-Dose Dexamethasone vs. Bortezomib and Low Dose Dexamethasone in patients with Relapsed or Refractory Multiple Myeloma. Protocol # 13-225 Paul Richardson, MD 617-632-2104 paul_richardson@dfci.harvard.edu MULTIPLE MYELOMA • Relapsed / Refractory A phase I open label study of panobinostat in combination with RVD in patients with Relapsed or Refractory Multiple Myeloma. Protocol # 13-262 Jacob Laubach, MD 617-582-7102 jacob_laubach@dfci.harvard.edu Winter 2014 www.dfbwcc.org/clinicaltrials Selected Protocols for the Treatment of Hematologic Malignancies in Adults Applicable Disease(s)/Treatment(s) Study Name Principal Investigator STEM CELL TRANSPLANT Standard of Care vs. Bortezomib in Graft-Versus-Host-Disease After Hematopoietic Stem Cell Transplant Protocol # 12-404 John Koreth, MBBS, DPhil 617-632-2949 john_koreth@dfci.harvard.edu Ibrutinib-TGR PI3K Inhibitor for Relapsed Patients Protocol # 14-396 Matthew Davids, MD 617-632-6331 matthew_davids@dfci.harvard.edu Single ProHema Modulated-Cord Blood Unit as Part of a Double Cord Blood Transplant in Patients with Hematologic Malignancies Protocol # 12-321 Corey Cutler, MD, MPH, FRCPC 617-632-5946 corey_cutler@dfci.harvard.edu Trial of Regulatory T-cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic Graft-Versus-Host-Disease Protocol # 13-281 John Koreth, MBBS, DPhil 617-632-2949 john_koreth@dfci.harvard.edu Phase 1 Study of Abatacept in the Treatment of Patients With Steroid Refractory Chronic Graft-Versus-Host-Disease Protocol # 13-358 Robert Soiffer, MD 617-632-6256 robert_soiffer@dfci.harvard.edu A Pilot Study of Alpha-1-Antitrypsin (AAT) in Steroid Refractory Acute Graft-versus-Host-Disease Protocol # 13-593 John Koreth, MBBS, DPhil 617-632-2949 john_koreth@dfci.harvard.edu Safety Study of Chimeric Antigen Receptor Modified T-cells Targeting NKG2D-Ligands Protocol # 14-386 Susanne Baumeister, MD 617-632-4687 susanne_baumeister@dfci.harvard.edu Ibrutinib With Rituximab in Previously Treated Adults with Waldenstrom’s Macroglobulinemia Protocol # 14-250 Steven Treon, MD, PhD 617-632-6844 steven_treon@dfci.harvard.edu GVHD STEM CELL TRANSPLANT CHRONIC LYMPHOCYTIC LEUKEMIA • Relapsed STEM CELL TRANSPLANT LEUKEMIA Acute Lymphocytic Leukemia • Remission Acute Myelogenous Leukemia • Remission Biphenotypic/Undifferentiated Leukemia • Remission LYMPHOMA Hodgkin Lymphoma • Remission Non-Hodgkin Lymphoma • Remission STEM CELL TRANSPLANT GVHD STEM CELL TRANSPLANT GVHD STEM CELL TRANSPLANT GVHD CELLULAR THERAPY LEUKEMIA Acute Myelogenous Leukemia MULTIPLE MYELOMA WALDENSTRÖM’S MACROGLOBULINEMIA •Previously Treated Winter 2014 www.dfbwcc.org/clinicaltrials Selected Protocols for the Treatment of Hematologic Malignancies in Adults The above-listed trials are only a sampling of our many open and accruing studies. If you are interested in, or would like more information about, a clinical trial listed here, please contact the principal investigator. For a broader listing of treatment protocols, please visit our website at www.dfbwcc.org/clinicaltrials. The clinical trials listed above are conducted through Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, and are available at other member institutions. *This trial is also available at Massachusetts General Hospital Cancer Center. Selected Protocols for the Treatment of Hematologic Malignancies in Adults www.dfbwcc.org/clinicaltrials Winter 2014