Ajay Gopal, MD, FACP

Research Interests

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 Studies

1. LLS T-NHL
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.

2. 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).

3. Project 2
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).

4. Project 3
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).

5. SG035-0003
Funding Source: Seattle Genetics, Inc.
A pivotal study of SGN-35 in treatment of patients with relapsed or refractory Hodgkin Lymphoma.

6. SGN35-006
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.

7. TREC C18083/6246
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.

8. BDG C18083/6250
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.

9. Zevalin
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.

10. Calistoga 101-09
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.

11. PF-05082566
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)

12. PRP-002
Funding Source: BioMarin Pharmaceutical, Inc.;
A Phase 1/2, Two-arm, Open-label Study of Once Daily, Oral BMN 673 in Patients with Advanced Hematological
Malignancies.

13. Calistoga 101-11
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.

14. Zevalin
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

15. 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).

16. ZEST
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.

17. Ibrutinib
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.