A5061859839- Lymphoma Diagnosis and Treatment
- Hematopoietic Stem Cell Transplantation
- Chronic Lymphocytic Leukemia Research
- CAR-T cell therapy research
- Viral-associated cancers and disorders
- Polyomavirus and related diseases
- Renal Transplantation Outcomes and Treatments
- Chronic Myeloid Leukemia Treatments
- Immune Cell Function and Interaction
- Acute Lymphoblastic Leukemia research
- T-cell and B-cell Immunology
- CNS Lymphoma Diagnosis and Treatment
- Lung Cancer Treatments and Mutations
- Medical Imaging Techniques and Applications
- Immunotherapy and Immune Responses
- Eosinophilic Disorders and Syndromes
- Cutaneous lymphoproliferative disorders research
- vaccines and immunoinformatics approaches
- Radiopharmaceutical Chemistry and Applications
- Viral Infectious Diseases and Gene Expression in Insects
- Health Systems, Economic Evaluations, Quality of Life
- Immunodeficiency and Autoimmune Disorders
- T-cell and Retrovirus Studies
- Acute Myeloid Leukemia Research
- Biomedical Ethics and Regulation
United States Food and Drug Administration
2017-2024
Center for Drug Evaluation and Research
2017-2024
Sidney Kimmel Comprehensive Cancer Center
2011-2021
Johns Hopkins Hospital
2010-2021
Sidney Kimmel Cancer Center
2014-2021
Johns Hopkins University
2010-2020
Johns Hopkins Medicine
2008-2018
National Cancer Institute
2014
St. Agnes Hospital
2010
Medical University of South Carolina
2010
Although some reports have found an association between increasing HLA disparity donor and recipient fewer relapses after allogeneic blood or marrow transplantation (BMT), this potential benefit has been offset by more graft-versus-host disease (GVHD) nonrelapse mortality (NRM). However, the type of GVHD prophylaxis might influence balance toxicity relapse. The present study analyzed impact greater on outcomes a specific platform for nonmyeloablative (NMA), HLA-haploidentical...
Extenuating circumstances can trigger unplanned changes to randomized trials and introduce methodological, ethical, feasibility, analytical challenges that potentially compromise the validity of findings. Numerous have required in response COVID-19 pandemic, but guidance for reporting such modifications is incomplete.As a joint extension CONSORT SPIRIT guidelines, CONSERVE (CONSORT Extension RCTs Revised Circumstances) aims improve trial protocols completed undergo important extenuating...
Purpose Recent advances in nonmyeloablative (NMA), related HLA-haploidentical blood or marrow transplantation (haplo-BMT) have expanded the donor pool. This study evaluated effect of age on NMA haplo-BMT outcomes patients 50 to 75 years. Patients and Methods A retrospective analysis was performed 271 consecutive with hematologic malignancies, years, who received NMA, T-cell–replete high-dose post-transplantation cyclophosphamide. Results The median 61 115 (42%) 59, 129 (48%) 60 69, 27 (10%)...
Abstract In October 2017, the FDA granted regular approval to axicabtagene ciloleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for treatment of adult patients with relapsed or refractory large B-cell lymphoma after two more lines systemic therapy. Efficacy was based on complete remission (CR) rate and duration response (DOR) in 101 (median 3 prior regimens) treated single-arm trial. Patients received single infusion preceded by lymphodepleting chemotherapy...
Abstract On May 17, 2016, after an expedited priority review, the U.S. Food and Drug Administration granted accelerated approval to nivolumab for treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed autologous hematopoietic stem cell transplantation (HSCT) post-transplantation brentuximab vedotin (BV). Nivolumab in cHL had been breakthrough therapy designation. Accelerated was based on two single-arm, multicenter trials adults cHL. In 95 progressive...
Composite endpoints that not only encompass mortality and relapse, but other critical post-transplant events such as graft-versus-host disease, are being increasingly utilized to quantify survival without significant morbidity after allogeneic blood or marrow transplantation. High-dose, post-transplantation cyclophosphamide reduces severe disease with transplantation, making composite this management particularly interesting. We retrospectively analyzed 684 adults hematologic malignancies...
The presence of donor human leukocyte antigen (HLA)-specific antibodies (DSA) increases engraftment failure risk in partially HLA-mismatched, or HLA-haploidentical, allogeneic marrow (alloBMT) transplantation. As pre-existing sensitization to HLA antigens is not well characterized among candidates for HLA-haploidentical alloBMT, we retrospectively evaluated both the incidence and relative strength DSA this patient population. Based on correlations solid-phase antibody assays Luminex...
Immunosuppressive regimens that effectively prevent graft-versus-host disease (GVHD) after allogeneic blood or marrow transplantation (allo-BMT) have been associated with an increased incidence of post-transplantation lymphoproliferative disorder (PTLD) in the first year transplantation. We evaluated PTLD use high-dose cyclophosphamide (PTCy) as GVHD prophylaxis. Between 2000 and 2011, a total 785 adult allo-BMT recipients were given PTCy prophylaxis at Johns Hopkins Hospital, including 313...
Allogeneic blood or marrow transplantation (BMT) candidates may lack HLA-matched, related haploidentical, and unrelated umbilical cord options. Barriers to partially HLA-mismatched, donor (mMUD) BMT include excess graft-versus-host disease (GVHD), graft failure, death. We prospectively studied nonmyeloablative (NMA) mMUD with high-dose posttransplantation cyclophosphamide (PTCy) for patients hematologic malignancies. Three transplants were performed busulfan/fludarabine conditioning,...
In June 2022, the FDA extended indication for lisocabtagene maraleucel (liso-cel) to include adults with large B-cell lymphoma (LBCL) who have refractory disease or relapse within 12 months of first-line chemoimmunotherapy (CIT), as well transplant-ineligible after CIT. Two clinical trials evaluating a single infusion liso-cel preceded by lymphodepleting chemotherapy supported second-line indications. TRANSFORM is randomized, phase 3, open-label trial comparing standard therapy, including...
Several interventions can cure posttransplant lymphoproliferative disease (PTLD); a sequential approach is usual, starting with reduction in immunosuppressives (RI). The efficacy of RI remains poorly defined, particularly adults. We assessed an algorithm defined course all patients, escalating to interferon (IFN) alpha2b, and finally chemotherapy, prospective multicenter phase II study adult solid organ transplant recipients. design predated rituximab.
Chronic myeloid leukemia (CML) can be responsive to T-cell-mediated immunity. K562/granulocyte macrophage-colony stimulating factor (GM-CSF) is a GM-CSF producing vaccine derived from CML cell line that expresses several CML-associated antigens. A pilot study was developed determine if K562/GM-CSF immunotherapy could improve clinical responses imatinib mesylate (IM) in patients with chronic leukemia.Patients phase who achieved at least major cytogeneic response but remained persistent,...
The role of allogeneic blood or marrow transplantation (alloBMT) for peripheral T cell lymphoma (PTCL) remains to be defined. There is growing interest in reduced-intensity conditioning (RIC) regimens and/or utilization human leukocyte antigen haploidentical (haplo) grafts given concerns about treatment-associated toxicities and donor availability. We reviewed the outcomes 44 consecutive, related alloBMTs PTCL performed at Johns Hopkins Hospital from 1994 2011, including 18 RIC/haplo...
Allogeneic stem cell transplantation (SCT) from an HLA-haploidentical relative provides a potentially curative treatment option for hematologic malignancies patients who lack suitably HLA-matched donor. The greatest challenge to performing SCT has been high rates of graft failure and severe graft-versus-host disease (GVHD). Our group exploring dose, post-transplantation cyclophosphamide (Cy) as prophylaxis GVHD after nonmyeloablative, bone marrow transplantation, or...