Winning pitch
This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase or calaspargase pegol work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial will also study the outcomes of patients with mixed phenotype acute leukemia (MPAL) and disseminated B lymphoblastic lymphoma (B-LLy) when treated with high-risk ALL chemotherapy.
The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, in order to classify patients into post-consolidation treatment groups. On the second part of this study, patients will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab. Other aims of this study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B-LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.
VICC Ambassadors
The VICC Ambassadors are the next generation of philanthropists committed to winning the battle against cancer by awarding Discovery Grants to promising researchers at Vanderbilt-Ingram Cancer Center.
Paul Harris, PhD, FACMI, FIAHSI
- Vice President for Research Informatics VUMC Office of Research Informatics
- Professor, Department of Biomedical Engineering
- Professor, Department of Biostatistics
- Professor, Department of Biomedical Informatics
Paul Harris, PhD, FACMI, FIAHSI
- Vice President for Research Informatics VUMC Office of Research Informatics
- Professor, Department of Biomedical Engineering
- Professor, Department of Biostatistics
- Professor, Department of Biomedical Informatics
paul.a.harris@vumc.org
Research Program
The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab
(MK-3475) in participants from previous Merck pembrolizumab-based parent studies who
transition into this extension study.
This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase
or 3) Second Course Phase. Each participant will transition to this extension study in one of
the following three phases, depending on the study phase they were in at the completion of
the parent study. Participants who were in the First Course Phase of study treatment with
pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this
study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6
weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or
lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the
parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up
Phase of this study. Participants who were in the Second Course Phase in their parent study
will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W
of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm
assignment.
Any participant originating from a parent trial where crossover to pembrolizumab was
permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of
pembrolizumab (approximately 2 years), if they progress while on the control arm and
pembrolizumab is approved for the indication in the country where the potential eligible
crossover participant is being evaluated.
This phase III trial compare the effects of adding definitive treatment (either radiation therapy or prostate removal surgery) to standard systemic therapy in treating patients with prostate cancer that has spread to other places in the body (advanced). Removing the prostate by either surgery or radiation therapy in addition to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.
