Nutritional and Metabolic Diseases

All Conditions

Infections

Symptoms and General Pathology

Digestive System Diseases

Immune System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

Gland and Hormone Related Diseases

Metabolic Diseases

Communicable Diseases

Gastrointestinal Diseases

Respiration Disorders

Respiratory Tract Diseases

Urologic Diseases

Hematologic Diseases

Endocrine System Diseases

Disease Attributes

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

No intervention

Bo Situ

Fluorescence is one of the most commonly used research and detection techniques in the field of biomedical science. The characteristics of fluorescent probe directly affect the performance and application of fluorescence analysis and imaging. Aggregation-Caused Quenching has limited the application of traditional fluorescent probes to some extent. This project intends to systematically evaluate the detection efficiency of new methods through the detection of biomarkers in clinical samples and the comparison with the detection methods of traditional biomarkers, so as to provide theoretical and experimental basis for the establishment of fast and simple biomarker detection technologies with new biological probes.

Research on the Application and Mechanism of New Biological Probes in Biomedicine

Nanfang Hospital, Southern Medical University

Neoplasms

Rare Diseases

Syndrome

Leukemia

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Precancerous Conditions

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Mitogens

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.

Participants took erlotinib at least 1 hour before, or 2 hours after they ate a meal or snack. Participants were advised to take erlotinib at around the same time every day.

Erlotinib

Rami Komrokji, M.D.

The purpose of this research study is to find out what effects, good and/or bad, erlotinib has on the patient and their myelodysplastic syndrome. Erlotinib has been approved by the Food and Drug Administration (FDA) to treat non-small cell lung cancer; however, erlotinib use in this study is considered investigational as the FDA has not approved it for the treatment of myelodysplastic syndrome.

Screening Period: Informed consent, physical examination, medical history report, blood tests, pregnancy test (if applicable), list of current medications, description of symptoms, chest x-ray, ECG, bone marrow aspirate/biopsy within 4 weeks of study start.

Weeks 2,6,10 and 14: Blood tests.

Weeks 4 and 12: Blood tests, physical exam, patients will answer question about how they are feeling and if there are any changes to medication they have taken.

Weeks 8 and 16: Blood tests, physical exam, patients will answer question about how they are feeling and if there are any changes to medication they have taken, bone marrow aspirate/biopsy (if physician has determined the patient has had a clinical response or partial response to treatment.

After week 16 (if responding to treatment): Have a bone marrow aspirate/biopsy (will be repeated at time of relapse, i.e., more than 50% increase in the percentage of myeloblasts \[leukemia cells\] or drop in blood counts after they improved or requiring regular blood transfusions after not requiring them for at least 8 weeks, or after 1 year in study).

After the patient has stopped taking erlotinib: Periodic follow-up on patients' status.

Erlotinib Study for Myelodysplastic Syndrome (MDS)

Phase II Study Evaluating the Role of Erlotinib an Epidermal Growth Factor Receptor (EGFR) Inhibitor in the Treatment of Myelodysplastic Syndrome

Best Response Categories: Marrow complete response (CR), Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment; Hematological improvement (HI), Hgb increase by ≥ 1.5 g/dL, Absolute increase of ≥ 30 x 10\^9/L for patients starting with \> 20 x 10\^9/L, At least 100% increase and an absolute increase of \> 0.5 x 10\^9/L, as defined by the International Working Group (IWG) 2006 criteria.

OS: The time from randomization until death from any cause. Kaplan-Meier estimates were used for secondary endpoint analysis.

PFS: The time elapsed between treatment initiation and tumor progression or death from any cause. Kaplan-Meier estimates were used for secondary endpoint analysis. Disease Progression is defined using International Working Group (IWG) Response Criteria for MDS, as at least 50% decrement from maximum remission/response levels in granulocytes or platelets; reduction in hemoglobin (Hgb) concentration by ≥ 2 g/dL; transfusion dependence.

LFS: Survival without evidence of relapse at any time post-transplant. Kaplan-Meier estimates were used for secondary endpoint analysis.

Genentech, Inc.

H. Lee Moffitt Cancer Center and Research Institute

Erlotinib Treatment

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

4 of the initial 39 patients were found to be ineligible after signing informed consent.

Rami Komrokji, Principal Investigator

Marrow Complete Response (CR)

Hematological Improvement (HI)

Combined Overall Response

All evaluable participants. Nine patients were not evaluable for response (withdrew consent or off study due to adverse event before first evaluation).

Combined Overall Response Rate (ORR)

Median Overall Survival (OS)

Median Progression Free Survival (PFS)

Leukemia Free Survival (LFS)

Overall Study

Heart and Blood Diseases

Polycythemia Vera

Polycythemia

Primary Myelofibrosis

Thrombocytosis

Thrombocythemia, Essential

Myeloproliferative Disorders

Bone Marrow Neoplasms

Hematologic Neoplasms

Blood Platelet Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Hemorrhagic Disorders

Essential Thrombocythemia

Chronic Myeloproliferative Disorders

Participants in Stage 1 of study will receive simtuzumab 200 mg for up to 24 weeks. Treatment could be continued if there is evidence of clinical benefit as judged by the treating physician.

Participants in Stage 1 of study will receive simtuzumab 700 mg for up to 24 weeks. Treatment could be continued if there is evidence of clinical benefit as judged by the treating physician.

In Stage 2, participants on stable doses of ruxolitinib will receive simtuzumab 200 mg for at least 24 weeks. Treatment could be continued if there is evidence of clinical benefit as judged by the treating physician.

In Stage 2, participants on stable doses of ruxolitinib will receive simtuzumab 700 mg for at least 24 weeks. Treatment could be continued if there is evidence of clinical benefit as judged by the treating physician.

Simtuzumab administered intravenously over approximately 30 minutes every 2 weeks

Simtuzumab

In Stage 2, participants will be on a stable dose of ruxolitinib

Ruxolitinib

Gilead Study Director

This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) on bone marrow fibrosis either alone or in combination with ruxolitinib in participants with primary myelofibrosis (PMF) and post polycythemia vera or post essential thrombocythemia myelofibrosis (ET/PV MF).

The study is designed as a two-stage trial. In the stage 1, participants will be randomized into two cohorts to receive either 200 or 700 mg of study drug. In the stage 2, participants on ruxolitinib will be randomized to receive either 200 or 700 mg of study drug.

Efficacy and Safety of Simtuzumab in Adults With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis

A Phase 2 Study to Evaluate the Efficacy and Safety of GS-6624 in Adult Subjects With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis

Overall response for the study drug is defined by the reduction in bone marrow fibrosis score which is on a scale of 0-3 where 0 indicates the scattered linear reticulin with no fiber intersections representing normal marrow and 3 indicates dense increase in reticulin fibrosis with fiber intersections, often with osteosclerosis. Reduction from baseline of score indicates improvement in clinical condition.

Overall response for the study drug was defined by the rate of clinical improvement in hemoglobin, platelet or ANC. Clinical improvement in hemoglobin was defined as a ≥ 2 g/dL increase from baseline in hemoglobin level and transfusion independent (absence of red blood cell (RBC) transfusions in prior 8 weeks and applicable only for participants with baseline hemoglobin level of \< 10 g/dL); clinical improvement in platelets was defined as a ≥ 100% increase from baseline in platelet count and an absolute platelet count of ≥ 50 x 10\^9/L (applicable only for participants with baseline platelet count \< 50 x 10\^9/L); clinical improvement in ANC is defined as a ≥ 100% increase from baseline in ANC and an ANC of ≥ 0.5 x 10\^9/L (applicable only for participants with baseline ANC \< 1 x 10\^9/L).

Myelofibrosis symptom assessment was performed using myeloproliferative neoplasm symptoms assessment form (MPN-SAF) which is a 27-item questionnaire to address symptom burden and quality of life. The form consists of 27 questions which are scored on a scale of 0-10 by participants based on how symptoms are affecting them, where 0 indicates less symptoms while 10 indicated more severe symptoms and greater inactivity. The MPN-SAF score was calculated at each visit for each participant as an average of the scales for each question and all answered questions. If the number of questions not answered at 1 visit was \> 10, then the MPN-SAF score for that visit was taken as missing. A negative change from Baseline indicated improvement.

Biomarker samples were collected to evaluate the effects of SIM treatment on markers of serum and plasma cytokines.

Blood samples were collected for the presence of anti-SIM antibodies which was determined using a validated electro-chemiluminescent (ECL) assay screening test.

Gilead Sciences

The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.

Participants were administered simtuzumab (SIM) 200 mg intravenous (IV) infusion over 30 minutes once every 2 weeks for a total of 6 infusions per 12-week cycle for up to 94 weeks.

Stage 1: SIM 200 mg

Participants were administered SIM 700 mg IV infusion over 30 minutes once every 2 weeks for a total of 6 infusions per 12-week cycle for up to 40 weeks.

Stage 1: SIM 700 mg

Participants on a stable dose of ruxolitinib were administered SIM 200 mg IV infusion over 30 minutes once every 2 weeks for up to 91 weeks.

Stage 2: SIM 200 mg+Ruxolitinib

Participants on a stable dose of ruxolitinib were administered SIM 700 mg IV infusion over 30 minutes once every 2 weeks for up to 86 weeks.

Stage 2: SIM 700 mg+Ruxolitinib

Total

Age, Customized

Ethnicity (NIH/OMB)

Race

Race/Ethnicity, Customized

The Per Protocol Analysis Set included participants who were randomized, received at least 1 dose of study drug, did not violate any major entry criteria and had at least 80% adherence with study drug. It is measured on a scale of 0-3 where 0 indicates normal marrow and 3 indicates fibrosis. For additional description, please see outcome measure 1.

Bone Marrow Fibrosis Score

Gilead Clinical Study Information Center

The Per Protocol Analysis Set included participants who were randomized, received at least 1 dose of study drug, did not violate any major entry criteria, and had at least 80% adherence with study drug.

Rate of Clinical Response as Defined by the Percentage of Participants With Reduction at Week 24 From Baseline in the Bone Marrow Fibrosis Score

Week 12

Week 24

Any Time Post-Baseline

Participants were administered SIM 200 mg IV infusion over 30 minutes once every 2 weeks for a total of 6 infusions per 12-week cycle for up to 94 weeks.

Participants in Per Protocol Analysis Set with available data were analyzed.

Rate of Clinical Response as Defined by the Percentage of Participants With Improvement in Hemoglobin, Platelet, or Absolute Neutrophil Count (ANC)

The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug

Percentage of Participants With Adverse Events (AEs)

Baseline

Best Change from Baseline

Change from Baseline at Cycle 1 - Day 43

Change from Baseline at Cycle 1 - Day 85

Change from Baseline at Cycle 2 - Day 43

Change from Baseline at Cycle 2 - Day 85

Change from Baseline at Cycle 3 - Day 43

Change from Baseline at Cycle 3 - Day 85

Change from Baseline at Cycle 4 - Day 43

Change from Baseline at Cycle 4 - Day 85

Change from Baseline at Cycle 5 - Day 43

Change from Baseline at Cycle 5 - Day 85

Change from Baseline at Cycle 6 - Day 43

Change from Baseline at Cycle 6 - Day 85

Change from Baseline at Cycle 7 - Day 43

Change from Baseline at Cycle 7 - Day 85

Participants in the Per Protocol Analysis Set with available data were analyzed.

Change From Baseline in Myelofibrosis Symptoms Assessment Score

Change From Baseline in Cytokine Levels

Baseline : Screened Negative

Baseline : Screened Positive

Cycle 1 - Day 85 : Screened Negative

Cycle 1 - Day 85 : Screened Positive

Cycle 2 - Day 85 : Screened Negative

Cycle 2 - Day 85 : Screened Positive

Cycle 3 - Day 85 : Screened Negative

Cycle 3 - Day 85 : Screened Positive

Cycle 4 - Day 85 : Screened Negative

Cycle 4 - Day 85 : Screened Positive

Cycle 5 - Day 85 : Screened Negative

Cycle 5 - Day 85 : Screened Positive

Participants in Safety Analysis Set with available data were analyzed.

Percentage of Participants With Anti-Simtuzumab Antibody Formation

Lenograstim

Adjuvants, Immunologic

Immunologic Factors

FILGRASTIM

The endogenous growth factor granulocyte (G-CSF) stimulates the proliferation and differentiation of hematopoietic progenitors commissioned to mature as neutrophils and activated granulocytes mature neutrophils. In the field of hematology oncology G-CSF it is used to reduce the duration and complications of chemotherapy-induced neutropenia and to stimulate the mobilization and subsequent collection of circulating hematopoietic stem cells in order to use them for autologous transplantation procedure.

Filgrastim and Lenograstim originator are marketed for many years and are considered the reference molecules for the production of biosimilar.

For several years it is available and entered into common clinical practice the use of filgrastim biosimilar (Bio-GCSF) in treating the patient oncohematologic.

Aim of the study is to analyze retrospectively a large series of patients and assess the impacts of the Bio-GCSF on the collection of hematopoietic stem cells and recovery of blood counts post autologous transplantation; the data will be compared with a historical cohort of reference that has been treated with G-CSF originator.

The study results will not generate any diagnostic or therapeutic intervention in patients still alive.

Efficacy of Biosimilar Filgrastim on the Mobilization of Hematopoietic Stem Cell CD34+ (Cluster of Differentiation 34) and on the Kinetic Engraftment

Efficacy of Biosimilar Filgrastim on the Mobilization of Hematopoietic Stem Cell CD34+ (Cluster of Differentiation 34) and on the Kinetic Engraftment After Autologous Transplant in Patients With Blood Cancers

the median time (in days) from the first day of chemotherapy mobilizing the effective collection of stem cells

the median number of white blood cells in the process of mobilization

the proportion of patients who have the mobilized peripheral blood stem cells with the aid of Plerixafor

cumulative incidence of granulocyte and platelet engraftment

the median time to achieve neutrophils\> 500 / ul for 3 consecutive days / platelets\> 20,000 / ul for 7 consecutive days

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Research on the Application and Mechanism of New Biological Probes in Biomedicine	NCT04977739	Tumors Cardiovascular ... Respiratory Sys... Digestive Syste... Endocrine Syste... Metabolic Disea... Immune System D... Urinary System ... Nervous System ... Blood Diseases Infectious Dise...	No intervention	18 Years - 70 Years	Nanfang Hospital, Southern Medical University
Research on the Application and Mechanism of New Biological Probes in Biomedicine	NCT04977739	Tumors Cardiovascular ... Respiratory Sys... Digestive Syste... Endocrine Syste... Metabolic Disea... Immune System D... Urinary System ... Nervous System ... Blood Diseases Infectious Dise...	No intervention	18 Years - 70 Years	Nanfang Hospital, Southern Medical University
Research on the Application and Mechanism of New Biological Probes in Biomedicine	NCT04977739	Tumors Cardiovascular ... Respiratory Sys... Digestive Syste... Endocrine Syste... Metabolic Disea... Immune System D... Urinary System ... Nervous System ... Blood Diseases Infectious Dise...	No intervention	18 Years - 70 Years	Nanfang Hospital, Southern Medical University
Erlotinib Study for Myelodysplastic Syndrome (MDS)	NCT00977548	Myelodysplastic...	Erlotinib	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Efficacy and Safety of Simtuzumab in Adults With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis	NCT01369498	Myelofibrosis	Simtuzumab Ruxolitinib	18 Years -	Gilead Sciences
Efficacy of Biosimilar Filgrastim on the Mobilization of Hematopoietic Stem Cell CD34+ (Cluster of Differentiation 34) and on the Kinetic Engraftment	NCT02806791	Blood Diseases	FILGRASTIM	-	Azienda Ospedaliera San Giovanni Battista
Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy?	NCT00892502	Hematological D... Hematological M... Blood Diseases Malignant Lymph... Leukemia Multiple Myelom...	Bismuth tablets Placebo tablets	18 Years - 75 Years	Copenhagen University Hospital at Herlev

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