Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Lymphosarcoma

peripheral blood collection at treatment start, interm PET/CT, end of treatment PET/CT, one-year and two-year follow-up and or progression or relapse

peripheral blood collection

Weili Zhao, MD，PhD

Pengpeng XU, MD, PhD

Weili ZHAO, MD, PhD

The purpose of this study is to assess whether plasma cell free DNA is an accurate tool that can early and dynamically inform on treatment outcome and an accessible source of tumor DNA to track tumor clonal evolution.

Cell Free DNA in Mature B-cell Lymphoma

Prospective, Observational Study on Cell Free DNA Genotyping as a Tool to Inform Mature B-cell Lymphoma Management

Ruijin Hospital

Professor

Symptoms and General Pathology

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Myeloproliferative Disorders

Myelodysplastic-Myeloproliferative Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Acute Myeloid Leukemia

Chronic Graft Versus Host Disease

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Chronic Myeloproliferative Disorders

Myelodysplastic/myeloproliferative Disease

Micronutrients

All Drugs and Chemicals

Vitamins

Ascorbic Acid

Vitamin C

Patients with a diagnosis of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML).

Peripheral blood collection for the measurement of ascorbic acid levels and banking of plasma and buffy coat for future resrearch.

Peripheral blood collection

Peter Jones, Ph.D., D.Sc.

This study is a non-interventional, specimen collection translational study to evaluate vitamin C levels in the peripheral blood of Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), or Chronic Myelomonocytic Leukemia (CMML) patients.

It has previously been established that hematological cancer patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) often exhibit severe vitamin C deficiency from a cohort of patients in Copenhagen. In this study, the investigators aim to determine if those results are conserved in another population/geographical location.

1. Plasma with ascorbic acid redox analysis prep (additive: MPA solution, 10 % meta-phosphoric acid w/v containing 2 mM Na2EDTA)
2. Plasma
3. Buffy coat pellet

Ascorbic Acid Levels in MDS, AML, and CMML Patients

Collection of Peripheral Blood From Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Chronic Myelomonocytic Leukemia for Measuring Baseline Ascorbic Acid Levels and Future Epigenetic Cancer Research

Van Andel Research Institute

Cheif Scientific Officer

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Hypersensitivity

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

Anti-Inflammatory Agents

Hormones

Abiraterone Acetate

Prednisone

Immunomodulating Agents

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Glucocorticoids

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

-Abiraterone acetate is an oral medication given at a dose of 1000 mg daily. Prednisone is an oral medication given at a dose of 5 mg daily. Nivolumab is given intravenously over 30 minutes on Day 1 of each 28-day cycle at a dose of 480 mg. Cabozantinib is an oral drug given daily; dosing will be 20 mg. Participants can continue to receive treatment for up to 2 years.

-Abiraterone acetate is an oral medication given at a dose of 1000 mg daily. Prednisone is an oral medication given at a dose of 5 mg daily. Nivolumab is given intravenously over 30 minutes on Day 1 of each 28-day cycle at a dose of 480 mg. Cabozantinib is an oral drug given daily; dosing will be 40 mg. Participants can continue to receive treatment for up to 2 years.

-Abiraterone acetate is an oral medication given at a dose of 1000 mg daily. Prednisone is an oral medication given at a dose of 5 mg daily. Nivolumab is given intravenously over 30 minutes on Day 1 of each 28-day cycle at a dose of 480 mg. Cabozantinib is an oral drug given daily; dosing will be dependent on recommended dose found in first part of study. Participants can continue to receive treatment for up to 2 years.

Cabozantinib

Abiraterone acetate

Prior to start of treatment, after 8 weeks of combination therapy, with every subsequent imaging (every 12 weeks), end of treatment

Russell K Pachynski, M.D.

The goal of this study is to determine the recommended phase 2 dose of the multi-drug combination of abiraterone, cabozantinib, and nivolumab in conjunction with ongoing androgen deprivation therapy in previously untreated metastatic hormone-sensitive prostate cancer patients. The investigators hypothesize that the combination of cabozantinib and abiraterone acetate/prednisone in conjunction with nivolumab will have an acceptable safety profile and will be feasible to administer in patients with hormone-sensitive metastatic prostate cancer.

Cabozantinib and Abiraterone With Checkpoint Inhibitor Immunotherapy in Metastatic Hormone Sensitive Prostate Cancer (CABIOS Trial)

A Phase 1b Clinical Trial of Cabozantinib and Abiraterone With Checkpoint Inhibitor Immunotherapy in Metastatic Hormone Sensitive Prostate Cancer (CABIOS Trial)

* Protocol defined hematologic DLTs that occur during the first cycle that are attributed as possibly, probably, or definitely related to study treatment
* Protocol defined non-hematologic DLTs possibly, probably, or definitely related grade 3 or 4 non-hematologic toxicity that occurs during the first cycle of treatment.

-Defined by at least 50% decline in PSA level from baseline measured twice at least 3 weeks apart

-Defined by proportion of patients achieving complete or partial response by RECIST 1.1 or by PCWG3 criteria

-Defined as from start of treatment to date of death (all cause) or last follow-up.

-Defined from start of treatment to date of progression or death or last follow-up, whichever is earlier.

-Defined as from start of treatment to to date of death due to disease or last follow-up.

-Defined as from date of first PSA response or radiographic complete response to date of recurrence of disease

-Defined from date of first PSA response to date of PSA progression or date of RECIST response to date of radiographic progression.

Bristol-Myers Squibb

Exelixis

Washington University School of Medicine

Digestive System Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Pembrolizumab

* Brachytherapy dose=16 Gy delivered in 2 fractions of 8 Gy per fraction, separated by 7-10 days between fractions.
* Pembrolizumab started within 1 week after completion of brachytherapy administered as an intravenous infusion over 30 minutes. It will be given every 3 weeks.
* Standard of care endoscopic biopsy will take place at time of enrollment and 2-6 months (optional) after pembrolizumab initiation.
* Research endoscopic biopsy for 8 consented patients will take place 1-2 weeks after initiation of brachytherapy.
* Peripheral blood will be collected: Pre-brachytherapy, Post-brachytherapy but pre-pembrolizumab (on day 1), Day 22 after the start of pembrolizumab, 3, 6, and 12 months (+/- 2 weeks) after the start of pembrolizumab, and time of progression

Brachytherapy

Endoscopic biopsy

Computed tomography-guided biopsy

Cliff Robinson, M.D.

The investigators propose to treat patients with metastatic esophageal cancers and dysphagia with two fractions of brachytherapy followed by pembrolizumab. The brachytherapy is hypofractionated and will provide a radiation dose of sufficient intensity to induce the release of tumor-derived antigens and trigger an antitumor immune response. The simplicity of the design should maximize the chance to examine the hypothesis that radiotherapy can induce an immune response, which can then be augmented by pembrolizumab treatment. Success in this study would provide the impetus to conduct further trials aimed at developing this unique strategy as a more broadly applicable therapeutic option in the treatment of patients suffering from these deadly cancers, and will provide important mechanistic insights into the relationship between radiation treatment and immune therapy augmentation.

Taken together, these data indicate that targeting the PD-1/PD-L1 axis in esophageal cancers in combination with radiation therapy may be a rational treatment strategy for these cancers.

Pembrolizumab With Locally Delivered Radiation Therapy for the Treatment of Metastatic Esophageal Cancers

A Pilot Study Combining Pembrolizumab With Locally Delivered Radiation Therapy for the Treatment of Metastatic Esophageal Cancers

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

-At the baseline tumor assessment, the sum of the products of the two largest perpendicular diameters (SPD) of all index lesions (five lesions per organ, up to 10 visceral lesions and five cutaneous index lesions) is calculated. At each subsequent tumor assessment, the SPD of the index lesions and of new, measurable lesions (≥5 x5 mm; up to 5 new lesions per organ: 5 new cutaneous lesions and 10 visceral lesions) are added together to provide the total tumor burden

Merck Sharp & Dohme LLC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cell Free DNA in Mature B-cell Lymphoma	NCT04088422	Mature B-Cell L...	peripheral bloo...	18 Years -	Ruijin Hospital
Cell Free DNA in Mature B-cell Lymphoma	NCT04088422	Mature B-Cell L...	peripheral bloo...	18 Years -	Ruijin Hospital
Cell Free DNA in Mature B-cell Lymphoma	NCT04088422	Mature B-Cell L...	peripheral bloo...	18 Years -	Ruijin Hospital
Ascorbic Acid Levels in MDS, AML, and CMML Patients	NCT03526666	Myelodysplastic... Acute Myeloid L... Chronic Myelomo... MDS AML CMML	Peripheral bloo...	18 Years -	Van Andel Research Institute
Cabozantinib and Abiraterone With Checkpoint Inhibitor Immunotherapy in Metastatic Hormone Sensitive Prostate Cancer (CABIOS Trial)	NCT04477512	Metastatic Horm...	Cabozantinib Nivolumab Abiraterone ace... Prednisone Peripheral bloo...	18 Years -	Washington University School of Medicine
Pembrolizumab With Locally Delivered Radiation Therapy for the Treatment of Metastatic Esophageal Cancers	NCT02642809	Esophageal Neop... Esophageal Canc... Cancer of the E...	Pembrolizumab Brachytherapy Endoscopic biop... Computed tomogr... Peripheral bloo...	18 Years -	Washington University School of Medicine

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