Ajay K. Gopal, MD
Department of Medicine
Division of Oncology
Seattle Cancer Care Alliance
825 Eastlake Ave E, G3-200
Seattle, WA 98109-1023
Bobby R Ou
Specialty / Expertise
- Hodgkin's lymphoma
- Chronic lymphocytic leukemia
- Diffuse large B-cell lymphoma
- Follicular lymphoma
- Low-grade lymphoma
- Mantle cell lymphoma
- Marginal zone lymphoma
Developing novel targeted therapies for lymphomas with particular emphasis on radioimmunotherapy-based transplant conditioning regimens, low toxicity Proapoptotic agents for indolent lymphomas, and safe curative regimens for older adults with lymphoma.
Current Research Projects
Leukemia & Lymphoma Society; Leukemia & Lymphoma Society Scholar in Clinical Research
The major goal of this grant is to translate laboratory data into the first clinical trial using high doses of radioactively tagged anti-CD45 antibody to deliver potentially curative radiation to multiple T-NHL prior to stem cell transplantation.
P01 CA 044991
NIH/NCI; Therapy of Lymphoma/Leukemia with Monoclonal Antibodies
This program project grant is developing improved strategies for treating patients with hematologic malignancies using radiolabeled monoclonal antibodies. It contains human clinical trials of high dose radioimmunotherapy with stem cell transplantation for leukemia (Project 1), lymphoma (project 2) and for pretargeted radioimmunotherapy of hematologic malignancies (Project 3).
Radiolabeled Therapy of Lymphoma; A phase I clinical trial of 90Y-labeled anti-CD45 BC8 antibody will be conducted in patients with lymphoma undergoing autologous stem cell transplantation. The optimal antibody protein dose of BC8 will be determined (Aim 1), direct comparisons of the biodistributions of CD45 and CD20 antibodies will be conducted (Aim 2), and the biodistributions of111In-BC8 with gamma camera imaging and 86Y-BC8 with PET imaging will be compared (Aim 3). Patients will be treated following the biodistribution studies with escalating doses of 90Y-BC8 to estimate the MTD in the setting of ASCT (Aim 4).
Pretargeted Radioimmunotherapy for Leukemia & Lymphoma
Phase I clinical trials of pretargeted radioimmunotherapy using anti-CD45 antibody conjugated to streptavidin followed by radiolabeled DOTA-biotin will be conducted in the setting of non-hematopoietic cell transplantation (HCT) for leukemia (Aim 1) and lymphoma (Aim 2). In addition, we the biodistributions and dosimetries of radiobiotin pretargeted using anti-CD45 BC8-SA will be compared with those observed with directly radiolabeled anti-CD45 BC8 Ab in patients with leukemia and lymphoma (Aim 3).
Funding Source: Seattle Genetics, Inc.
A pivotal study of SGN-35 in treatment of patients with relapsed or refractory Hodgkin Lymphoma.
Funding Source: Seattle Genetics, Inc.
A phase II trial of treatment with SGN-35 in patients with CD30-positive hematologic malignancies who have previously participated in an SGN-35 study.
Funding Source: Cephalon Inc.
A Phase I trial of Bendamustine/Treanda (T), Rituximab (R), Etoposide (E), and Carboplatin (C) for patients with relapsed or refractory lymphoid malignancies and select untreated lymphomas.
Funding Source : Cephalon Inc.
A phase II trial of Bendamustine (B), Dexamethasone (D), and G-CSF (G) for peripheral blood hematopoietic stem cell mobilization.
The major goal of this project is to determine the ability of bendamustine to be successfully used as a PBSC mobilization.
Funding Source: Biogen-Idec
Zevalin-mini allo; The major goal of this project is to conduct a Phase II trial evaluating the efficacy of Non-myeloablative 90Y-anti-CD20 Antibody, Fludarabine, Low-Dose total body irradiation (TBI) and matched related allogeneic transplantation for relapsed indolent B-Cell Lymphoma.
Funding Source: Gilead Sciences, Inc.
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.
The major goal of this Phase 2 Study is to assess the efficacy and safety of CAL-101 in patients with relapsed or refractory Hodgkin lymphoma.
Funding Source: Pfizer
A Phase 1 Study of PF-05082566 as a single agent in patients with advanced cancer, and in
combination with rituximab in patients with Non-Hodgkin's LYMPHOMA (NHL)
Funding Source: BioMarin Pharmaceutical, Inc.;
A Phase 1/2, Two-arm, Open-label Study of Once Daily, Oral BMN 673 in Patients with Advanced
Funding Source: Calistoga Pharmaceuticals, Inc.
A phase II study to assess the efficacy and safety of CAL-101-11 in patients with relapsed or
refractory Hodgkin lymphoma.
Funding Source: Spectrum Pharmaceuticals, Inc.
A phase II trial of high-dose 90Y-Ibritumomab tiuxetan (anti-CD20) followed by fludarabine and low-dose total body irradiation and HLA-matched allogeneic hematopoietic transplantation for patients with relapsed or refractory aggressive B-cell lymphoma
Weekly Brentuximab Vedotin
Funding Source: Seattle Genetics
A phase II trial of weekly brentuximab vedotin in patients refractory to every 3 week bretuximab vedotin; The major purposes of this trial are to evaluate the ability of dose dense brentuximab vedotin (BV) to overcome BV resistance and to describe and quantify the patterns of CD30 expression in BV responders and non-responders. (Investigator-Initiated).
Funding Source: Spectrum Pharmaceuticals
A Phase 3, Open-label, Multicenter, Randomized Study of Sequential Zevalin (ibritumomab tiuxetan) versus Observation in Patients at Least 60 Years of Age with Newly Diagnosed Diffuse Large B-cell Lymphoma in PET-negative Complete Remission After R-CHOP-like Therapy (ZEAL or ZEST); The major goal of this study is to evaluate the benefit of Zevalin consolidation for older adults with high-risk diffuse large B-cell lymphoma.
Funding Source: Janssen Research & Development
An Open-Label, Multicenter, Single-Arm, Phase 2 Study of PCI-32765 (Ibrutinib) in Subjects with Refractory Follicular Lymphoma; A Phase II study to evaluate and quantify the response rate of patients with refractory FL receiving oral ibrutinib. Safety, survival, and pharmacokinetics will be evaluated.
Dr. Gopal received his BS from Duke University, Durham, NC, and his MD from Emory School of Medicine, Atlanta, GA. He completed his Internal Medicine Residency at Duke University Medical Center, Durham, NC, where he was selected as Assistant Chief Resident. He then completed his Medical Oncology Fellowship at the University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA in 1997.
Gopal AK, Press OW, Shustov A, Petersdorf S, Gooley T, Daniels J, Garrison M, Gierset G, Lonergan M, Murphy A, Smith J, Pagel JM. Efficacy and safety of gemcitabine, carboplatin, dexamethasone, and rituximab in patients with relapsed/refractory lymphoma: a prospective multi-center phase II study by the Puget Sound Oncology Consortium. Leuk Lymphoma. 2010 Aug; 51(8):1523-9. PMCID: 20578815.
Budde LE, Guthrie KA, Till BG, Press OW, Chauncey TR, Pagel JM, Petersdorf SH, Bensinger WI, Holmberg LA, Shustov AR, Green DJ, Maloney DG, Gopal AK. Mantle cell lymphoma international prognostic index but not pretransplantation induction regimen predicts survival for patients with mantle-cell lymphoma receiving high-dose therapy and autologous stem-cell transplantation. J Clin Oncol. 2011 Aug 1; 29(22):3023-9. Epub 2011 Jul 5. PMID: 21730271.
Gopal AK, Guthrie K, Rajendran J, Pagel JM, Oliviera G, Matesan M, Maloney DG, Storb RF, Press OW. Y-90-Ibritumomab Tiuxetan, Fludarabine and TBI Based Non-Myeloablative Allogeneic Transplant Conditioning for patients with persistent High-Risk B-Cell Lymphoma. Blood. 2011 July 28; 118(4): 1132-9. PMID: 21508413.
Shustov AR, Cherian S, Shaw A, Lupinacci T, Maloney D, Holmberg L and Gopal AK. In-vivo purging of the circulating clonal T-cells with Alemtuzumab prior to autologous peripheral blood hematopoietic cell mobilization and transplantation. Br J Haematol. 2011 Aug: 154(3):415-8. PMID: 21488858
Ram R, Gooley TA, Maloney DG, Press OW, Pagel JM, Petersdorf SH, Shustov AR, Flowers MED, O’Donnell P, Sandmaier BM, Storb RF and Gopal AK. Histology and Time to progression predict survival for lymphoma recurring after reduced intensity conditioning and allogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplantation. 2011 Oct; 17(10): 1537-45. PMID: 21536145 PMCID: PMC3176968.
Younes A, Gopal AK, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Ramachandran R, Bartlett NL, Cheson BD, de Vos S, Forero-Torres A, Msokowitz C, Connors JM, Engert A, Larsen EK, Kennedy DA, Sievers EL, and Chen R. Results of a Pivotal Phase II Study of Brentuximab Vedotin for Patients with Relapsed or Refractory Hodgkin Lymphoma. Journal of Clincal Oncology. 2012 Mar 26. PMID: 22454421.
Gopal AK, Ramchandren R, O’Connor OA, Berryman RB, Advani RH, Chen R, Smith SE, Cooper M, Rothe A, Matous JV, Grove LE, Zain J. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplant. Blood. 2012 Apr 1. PMID: 22510871.
Fromm JR, McEarchern JA, Kennedy D, Thomas A, Shustov AR, Gopal AK. Clinical Binding Properties, Internalization Kinetics, and Clinicopathological Activity of Brentuximab Vedotin: An Antibody-Drug Conjugate for CD30-positive Lymphoid Neoplasms. Clinical Lymphoma, Myeloma & Leukemia. 2012 Aug; 12(4):280-3. Epub 2012 Apr 26. PMID: 22542449.
Chen R, Palmer JM, Thomas SH, Farol L, Nadermanee A, Forman SJ, Gopal AK. Brentuximab vedotin enables successful reduced-intensity allogeneic hematopoietic cell transplantation in patients with relapsed or refractory Hodgkin lymphoma. Blood. 2012 Jun 28; 119(26):6379-81. Epub 2012 May 18. PMID: 22611160.
Budde LE, Zhang MM, Shustov AR, Pagel JM, Gooley TA, Oliveira G, Chen TL, Warr TA, Boyd TE, Press OW, and Gopal AK. A Phase I Study of Pulse High-Dose Vorinostat (V) plus Rituximab (R), Ifosphamide, Carboplatin, and Etoposide (ICE) in Patients with Relapsed Lymphoma. Br J Haematol. 2013 Jan 29. PMID: 23356514.
Cassaday RD, Guthrie KA, Budde LE, Thompson L, Till BG, Press OW, Chauncey TR, Pagel JM, Petersdorf SH, Palanca-Wessels MC, Philip M, Bensinger WI, Holmberg LA, Shustov A, Green DJ, Libby EN, Maloney DG, Gopal AK. Specific features identify patients with relapsed/refractory mantle cell lymphoma benefitting from autologous hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2013 Sept; 19(9):1403-6. PMID: 23871782.
Press OW, Unger JM, Rimsza LM, Friedberg JW, Leblanc ML, Czuczman MS, Kaminski M, Braziel RM, Spier CM, Gopal AK, Maloney DG, Cheson BD, Dakhil SR, Miller TP, Fisher R. A Comparative Analysis of Prognostic Factor Models for Follicular Lymphoma based on A Phase III Trial of CHOP-Rituximab vs CHOP + 131Iodine-Tositumomab. Clin Cancer Res. 2013 Oct 15. [Epub ahead of print]. PMID: 24130072.
Gopal AK, Barlett NL, Foreto-Torres A, Younes A, Chen R, Friedberg JW, Matous JV, Shustov AR, Smith SE, Zain J, O’Meara MM, Fanale MA. Brentuximab Vedotin in Patients Aged 60 Years or Older with Relapsed or Refractory CD30+ Lymphomas: A Restrospective Evaluation of Safety and Efficacy. Leuk Lymphoma. 2013 Dec 22. [Epub ahead of print]. PMID: 24359243.
Green DJ, Orgun NN, Hylarides MD, Pagel JM, Hamlin D, Wilbur DS, Lin Y, Fisher DR, Kenoyer A, Frayo SL, Gopal AK, Orozco JJ, Gooley TA, Wood BL, Bensinger WI, Press OW. A Preclinical Model of CD38-pretargeted radioimmunotherapy for plasmas cell malignancies. Cancer Res. 2013 Dec 26. PMID 24371230.
Gopal AK, Kahl BS, de Vos S, Wagner-Johnston ND, Schuster SJ, Jurczak WJ, Flinn IW, Flowers CR, Martin P, Viardot A, Blum KA, Goy AH, Davies AJ, Zinzani PL, Dreyling M, Johnson D, Miller LL, Holes L, Li D, Dansey RD, Godfrey WR, Salles GA. PI3Kδ Inhibition by Idelalisib in Patients with Relapsed Indolent Non-Hodgkin Lymphoma Refractory to Rituximab and an Alkylating Agent. New England Journal of Medicine. 2014 Jan 22. PMID: 24450858.
Last updated: February 2014