Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

Patients with relapsed or refractory T cell Lymphoma who meet eligibility criteria will be enrolled to receive ONO-4685 monotherapy

ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed

ONO-4685

Ono Pharma USA, Inc.

Project Leader

This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma

Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma

An Open-label, Multi-center, Non-randomized Phase I Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ONO-4685 Given as Monotherapy in Patients With Relapsed or Refractory T Cell Lymphoma

Adverse events with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 used as a guide for the grading of severity.

MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment

Plasma concentration will be assessed to evaluate Pharmacokinetics

ADA to ONO-4685 will be assessed to evaluate potential immunogenicity.

Antitumor Activity of ONO-4685 will be assessed according to the response criteria for Lymphoma.

Ono Pharmaceutical Co. Ltd

Symptoms and General Pathology

Infections

Syndrome

Mycoses

Mycosis Fungoides

Lymphoma, T-Cell, Cutaneous

Sezary Syndrome

Bacterial Infections

Communicable Diseases

Bacterial Infections and Mycoses

Cutaneous T-cell Lymphoma

Anti-Infective Agents

Doxycycline

Anti-Bacterial Agents

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Doxycycline in either capsules or tablets will be administered at 400mg total per day. Patients will be treated for five months, or up to one year for those with a partial response at 5 months.

Doxycycline will be administered in either tablets or capsules for either five months or a year depending on response.

Doxycycline monohydrate

Brian Poligone, M.D. Ph.D.

This study looks at the efficacy of Doxycycline for the treatment of Cutaneous T-cell Lymphomas.

The aim of this study is to evaluate the efficacy of doxycycline in relapsed Cutaneous T-cell Lymphomas (CTCL). The primary objective is to determine the overall response rate of doxycycline monotherapy in patients with relapsed CTCL.

Doxycycline for the Treatment of Cutaneous T-Cell Lymphoma

Doxycycline in Patients With Relapsed Cutaneous T-cell Lymphoma

Changes in quality of life will be measured throughout the study using questionnaires.

Overall response rate will be determined after five months or a year from initiation of therapy.

Patients who achieve a Partial Response or Complete Response will be monitored for progression up to one year after initiation of therapy.

Rochester General Hospital

Scientist II

Anti-Inflammatory Agents

Antineoplastic Agents

Antirheumatic Agents

Analgesics

Herbal and Botanical

Turmeric extract

Curcumin

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Enzyme Inhibitors

Antioxidants

Protective Agents

Turmeric

Chew then swallow 2 sticks per day for up to 6 months.

2 sticks = 1 packet of curcumin = 8 grams

Curcumin (Turmeric)

Quality of life (QOL) questionnaires completed on Day 1, Weeks 2, 4, 8, 12, 16, 20, and at end of treatment visit.

Questionnaires

Photos of up to 6 selected skin lesion(s) and half-body photos taken on Day 1, Weeks 2, 4, 12, and at end of treatment visit.

Photos

Madeleine Duvic, MD

The goal of this clinical research study is to learn if treatment with curcumin can help to decrease the size of lesions and/or decrease itching in patients with MF or SS. The safety of curcumin will also be studied.

Curcumin:

Curcumin, a yellow substance taken from a plant, is commonly used in cooking as a spice called turmeric. In this study, participants will receive much higher doses of curcumin than can be received through food.

Curcumin may block proteins that help cells to divide. These proteins also may stop cancer cells from dying.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will swallow 2 sticks of curcumin per day. You should take the 2 sticks each morning with food and enough water for you to be able to swallow them. If you miss taking a dose of curcumin in the morning, you can take it later that day (as soon as you remember). However, if you miss a dose all day, do not take 2 doses the next day to make up for it.

Study Visits:

You will be asked to return for study visits.

At "baseline" (Day 1), the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs.
* You will be asked to rate your itching on a scale of 0-10.
* You will complete the 2 quality-of-life questionnaires.
* The study staff will take photos of up to 6 selected skin lesion(s). These will be close-up photos of the lesions and a small area of surrounding skin. "Half-body" photos will also be taken. These will be front, back, and/or side views of the top and bottom half of your body, depending on where the lesions are. For the half-body photos, your private areas will be covered (as much as possible), and your face will not be included in the photos unless there are lesions there.
* Blood (about 3 teaspoons) will be drawn for routine tests
* You will complete 2 "quality-of-life" questionnaires that ask how the symptoms of the disease may be affecting your life. This should take about 5 minutes.
* You will have a physical exam, including having skin lesions and affected areas of your skin looked at by the study doctor.
* If the study doctor thinks it is needed, you will have a skin biopsy performed. To perform a skin biopsy, the area is numbed with anesthetic and a small amount of tissue (about the size of a pencil eraser) is removed with a special tool.

The following tests and procedures will be performed at Weeks 2, 4, 8, 12, 16, and 20:

* You will have a physical exam, including having skin lesions and affected areas of your skin looked at by the study doctor.
* You will complete the 2 quality-of-life questionnaires.
* Your vital signs will be measured.
* You will be asked to rate your itching on a scale of 0-10.

At Weeks 2, 4, and 12 only, the following additional test will be performed:

-Just like at baseline, you will have skin lesion photos and half-body photos taken.

At Weeks 4, 12, and 20 only, the following additional test will be performed:

-Blood (about 3 teaspoons) will be drawn for routine tests.

If the doctor decides it is needed based on abnormal blood tests at screening, additional blood (about 1 teaspoon) will be drawn to check the status of the disease at Weeks 2, 4, 8, and 12.

If at any time during the study the skin disease seems to have cleared, you will have a skin biopsy performed in order to confirm the response.

Length of Study Participation:

You may continue receiving the study drug for up to 6 months, as long as you and the study doctor think you are benefitting from taking curcumin. If the disease gets worse or intolerable side effects occur at any time during this study, you will be taken off study.

End-of-Treatment Visit:

When you go off study for any reason, you will have an end-of-treatment visit. The following procedures will be performed:

* You will have a physical exam.
* You will be asked to rate your itching on a scale of 0-10.
* Blood (about 2 teaspoons) will be drawn for routine tests.
* If the doctor decides it is needed based on abnormal blood tests at screening, additional blood (about 1 teaspoon) will be drawn to check the status of the disease.
* A skin biopsy will be performed to check the status of the disease.
* Photos of the skin lesion(s) will be taken.
* You will complete the 2 quality-of-life questionnaires.
* You will have a CT and/or PET scan to check the size of the lymph nodes.

Follow-Up:

Every 3 months for 6 months after your last dose of the study drug, the study staff will check the results of any routine tests that were performed at your regular follow-up visits for MF or SS. If you do not visit the clinic during one or both of these two 3-month time periods, you will be called at home at 3 months and/or 6 months after your last dose of the study drug. The purpose of the phone calls is to ask how you are doing.

This is an investigational study. Curcumin is not FDA approved or commercially available for the treatment of cutaneous T-cell lymphoma. For this purpose, it is being used in research only.

Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.

Trial of Curcumin in Cutaneous T-cell Lymphoma Patients

Phase II Trial of Curcumin in Cutaneous T-cell Lymphoma Patients

M.D. Anderson Cancer Center

Skin and Connective Tissue Diseases

Sarcoma

Sarcoma, Synovial

Rhabdoid Tumor

Chordoma

Neoplasms, Connective and Soft Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Synovial Sarcoma

Epithelioid Sarcoma

Dermatologic Agents

Coal Tar

Up to approximately 104 patients will be enrolled in dose escalation and expansion.

FHD-609 as a single, intravenously administered agent given twice-weekly (BIW). Alternative dosing regimens may be evaluated.

FHD-609

Sarah Reilly, MD

This Phase 1, multicenter, open-label, dose escalation and expansion study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of FHD-609 given intravenously in subjects with advanced synovial sarcoma or advanced SMARCB1-loss tumors.

This study is an ascending multiple dose clinical trial with expansion arms. It is primarily intended to evaluate the safety and tolerability of FHD-609 when administered intravenously to subjects with advanced synovial sarcoma or advanced SMARCB1-loss tumors. The Dose Escalation Phase will allow for the determination of the recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) of FHD-609. This study will also evaluate the PK/PD profiles of multiple dose administration of FHD-609.

The Dose Expansion Phase will allow a more robust evaluation of the safety profile of FHD-609, including toxicities that may occur less frequently, and an assessment of anti-tumor activity. The data from this study in subjects with advanced synovial sarcoma, including safety, tolerability, PK/PD findings, and anti-tumor activity, will form the basis for subsequent clinical development of FHD-609.

Open label single arm dose escalation and three-arm expansion study in patients with advanced synovial sarcoma or advanced SMARCB1-loss tumors

FHD-609 in Subjects With Advanced Synovial Sarcoma or Advanced SMARCB1-Loss Tumors

A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Intravenously Administered FHD-609 in Subjects With Advanced Synovial Sarcoma or Advanced SMARCB1-Loss Tumors

During first 6 weeks of treatment for each patient in dose escalation

ORR is defined as the percentage of subjects achieving a complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.

DOR is defined as the time from first documented evidence of CR or PR until the earliest date of documented radiological progression per RECIST 1.1. or death due to any cause among subjects who achieved a CR or PR

PFS defined as the time from first dose of study treatment until the first date of either objective disease progression per RECIST 1.1. or death due to any cause, whichever happens first

TTR is defined as the period of time from the date of first study drug administration until the first objective documentation of response per RECIST 1.1.

OS is defined as the time from first dose of study treatment to the date of death, irrespective of the cause of death.

Plasma concentration of FHD-609 at the scheduled timepoints

Foghorn Therapeutics Inc.

Antibodies, Monoclonal

Mogamulizumab

In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.

KW-0761

Michael Kurman, M.D.

This study will enroll subjects with either Peripheral T-Cell Lymphoma (PTCL) or Cutaneous T-Cell Lymphoma(CTCL),including mycosis fungoides (MF) and Sezary Syndrome (SS), who have relapsed after achieving a complete response in study, KW-0761-001.

Extension Study in Subjects Who Relapsed After Complete Response on Study KW-0761-001

Open-Label Extension Study of Anti-CCR4 Monoclonal Antibody KW-0761 as Monotherapy in Subjects Who Relapsed After Complete Response on Study KW-0761-001

Kyowa Hakko Kirin Pharma, Inc.

Kyowa Kirin Co., Ltd.

KW-0761: In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.

Age, Categorical

Sex: Female, Male

White, Hispanic or Latino

Race/Ethnicity, Customized

United States

Region of Enrollment

Only subjects with PTCL or CTCL who subsequently relapsed after achieving a CR in Study KW 0761-001 and who provided signed informed consent were eligible to enroll in the study.

Kyowa Kirin Pharmaceutical Development

Progression-Free Survival (PFS)

Time to Progression (TTP)

Duration of Overall Response (DR)

Safety Analysis Set: All subjects who received at least one dose of KW-0761 (even a partial dose).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma	NCT05079282	Relapsed or Ref...	ONO-4685	18 Years -	Ono Pharmaceutical Co. Ltd
Doxycycline for the Treatment of Cutaneous T-Cell Lymphoma	NCT02341209	Cutaneous T-cel... Mycosis Fungoid... Sezary Syndrome	Doxycycline mon...	18 Years -	Rochester General Hospital
Trial of Curcumin in Cutaneous T-cell Lymphoma Patients	NCT00969085	Cutaneous T-cel...	Curcumin (Turme... Questionnaires Photos	-	M.D. Anderson Cancer Center
FHD-609 in Subjects With Advanced Synovial Sarcoma or Advanced SMARCB1-Loss Tumors	NCT04965753	Advanced Synovi...	FHD-609	16 Years -	Foghorn Therapeutics Inc.
Extension Study in Subjects Who Relapsed After Complete Response on Study KW-0761-001	NCT01226472	Peripheral T-ce... Cutaneous T-cel...	KW-0761	18 Years -	Kyowa Kirin Co., Ltd.

Spots Global Cancer Trial Database for ss

Every month we try and update this database with for ss cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ss

Every month we try and update this database with for ss cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ss cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.