Clinical Research Directory

Sintilimab Combined With Chidamide in Treating Peripheral T Cell Lymphoma

This is a single-center, single-arm, phase 2 study to evaluate the efficacy and safety of Anti-PD-1 antibody(Sintilimab) plus HDAC inhibitor(Chidamide) in patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL).

Amping up With PemJAK

The purpose of this study is to understand and determine if ruxolitinib added to pembrolizumab is safe and effective for the treatment of relapsed or refractory Hodgkin and non-Hodgkin lymphomas.

Linperlisib Combined With Chidamide in Patients With PTCL

The phase Ib part of this study aims to determine the recommended phase II dose （RP2D）of linperlisib in combination with chidamide for the treatment of peripheral T-cell lymphoma (PTCL). The phase IIa part is designed to evaluate the preliminary efficacy and safety of the linperlisib plus chidamide regimen in newly diagnosed PTCL patients. The phase IIb part compares the efficacy and safety of linperlisib combined with chidamide versus the standard CHOP (CHOP-like) regimen in newly diagnosed PTCL patients.

BrEto-TCL - Defining the Role of Brentuximab and Etoposide for Optimizing First-line Therapy of T-cell Lymphomas

There is no data comparing the effectiveness of the 4 most relevant first-line therapy programs for peripheral T-cell lymphomas (CHOEP, CHOP, CHEP-BV, CHP-BV) in a single study. For the first time, the effectiveness and toxicity of various first-line PTCL therapy programs in patients with T-cell lymphoma will be analyzed in the conditions of a single medical center of the N.N.Petrov National Research Medical Center of Oncology and optimal therapeutic tactics will be determined, taking into account significant prognostic factors based on effectiveness and toxicity a specific chemotherapy regimen.

A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19)

This is a phase 3, open-label, randomized, multinational study to evaluate the anti-tumor efficacy of golidocitinib versus investigator's choice in adult patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL). This study will treat patients with pathologically confirmed PTCL who have relapsed after or been refractory/intolerant to at least one prior systemic treatment regimen(s).

Constitutive IL7R (C7R) Modified Banked Allogeneic CD30.CAR EBVSTS for CD30-Positive Lymphomas

This study involves patients that have a cancer called diffuse large B cell lymphoma (DLBCL), Natural killer/T-cell lymphoma (NKTL), or classical Hodgkin lymphoma (cHL) (referred to collectively as lymphoma). Patients' lymphoma has come back or not gone away after treatment. A previous research study at Baylor combined two ways of fighting disease: antibodies and T cells. Antibodies are proteins that bind to bacteria, viruses and other foreign substances to prevent disease. T-cells are special infection-fighting white blood cells that can kill tumor cells or cells infected with bacteria and viruses. Both have shown promise treating cancer, but neither has been strong enough to cure most patients. In the previous study, an antibody called anti-CD30 which is found on the surface of some T-cells and cancer cells, and had been used to treat lymphoma with limited success, was joined to the T-cells through a process called gene transfer, resulting in CD30.CAR T cells. Another study saw encouraging responses using CD30.CAR T cells made in a lab from a patients' own blood then injected back into the same patient to treat their lymphoma. These cells are termed 'autologous' because they're given back to the original patient. In an ongoing study, patients were treated with allogeneic CD30.CAR T cells, which are made from healthy donors instead of the patients. The use of allogenic cells avoids a lengthy manufacture time since the products are stored as a bank and available on demand. This ongoing trial has preliminarily shown promising clinical activity with no safety concerns. With the current study, investigators plan to extend the anti-cancer effects of the CD30.CAR T cell by attaching another molecule called C7R, which has made CAR T cells have deeper and longer anticancer effects in the laboratory. The aim is to study the safety and effectiveness of allogeneic banked CD30.CAR-EBVST cells that also carry the C7R molecule, to learn the side effects of C7R modified CD30.CAR-EBVST cells in lymphoma patients, and to see whether this therapy may help them. As an extra safety step, the C7R containing T cells will also have a marker called iC9. If a patient experiences intolerable side effects from the C7R T cells, they could receive a medication called 'rimiducid' that can eliminate the C7R containing T cells by binding iC9, thereby potentially resolving the side effects. While not yet FDA approved, rimiducid has been tested in patients before without bad side effects.

Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma

This study evaluates a fenretinide phospholipid suspension for the treatment of T-cell non-Hodgkin's lymphoma (NHL).

Bendamustine Combined With Chidamide and Lenalidomide for Relapsed and Refractory PTCL Patients

To evaluate the efficacy and safety of bendamustine combined with chidamide and lenalidomide in R/R PTCL patients.

A Clinical Trial in Adults With Non-Hodgkin Lymphoma (NHL), With a Particular Emphasis on Cutaneous T Cell Lymphoma (CTCL), Testing the Safety and Activity of a Novel Drug to Inhibit a Protein Called Tumor Necrosis Factor Receptor 2 That Drives Both Lymphoma Growth and Escape of the Immune System

The goal of this trial is to learn if a new drug, BITR2101, works to treat non-Hodgkin lymphoma (NHL) in adults, with CTCL patients being sought in particular. The trial also seeks to learn about the safety of this drug. This drug is a protein called an antibody. The drug prevents a molecule called a receptor, named TNFR2, from being made. TNFR2 regulates the immune system and provides important signals to lymphoma cells to grow, make more of themselves and survive. When the drug prevents TNFR2 from being produced in lymphoma cells from CTCL patients, those cells died in the laboratory. Therefore, the trial seeks to enroll CTCL patients in particular, in addition to other subtypes of NHL. When the drug prevents the receptor from being made in certain immune cells, there is increased immune activity. Thus, the trial will test if this drug is a new immune therapy that helps the immune system to keep lymphoma under control. In particular, we want to find out if the amount of lymphoma in the body decreases while taking the drug. Patients with autoimmune diseases are not permitted because of this potential increase in immunity brought on by this drug. Patients should have NHL that has been previously treated, that is getting worse on their current therapy, and their doctors think a new treatment is needed. All patients will receive BITR2101 by a 3 hour infusion into a vein, periodically, initially every 3 weeks. There is no placebo in this trial. Visits to the clinic facility will be required, initially at least every week and later less frequently. Patients will be expected to report changes in their health to the clinic staff including new findings and any change in the status of their lymphoma they may be aware of. Patients can continue to receive BITR2101 for up to a year or until their lymphoma worsens. For patients who are clearly benefiting, they may be able to receive BITR2101 for another year.

A Clinical Study of CHT101 in CD70-Positive Relapsed or Refractory Hematological Malignancies

Evaluate the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies

Chidamide Plus Golidocitinib in Relapsed/Refractory Peripheral T-Cell Lymphoma

This is a Phase I/II, open-label, single-arm study investigating the combination of chidamide and golidocitinib in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The Phase I portion utilizes a 3+3 dose-escalation design to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of the drug combination. The Phase II portion will then evaluate the efficacy and safety of the RP2D in approximately 28 patients with relapsed or refractory PTCL. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or meeting other stopping criteria. The primary goal of Phase I is to establish the safety and MTD and the RP2D. The primary goal of Phase II is to evaluate the treatment efficacy and safety of the combination at RP2D.

Golidocitinib Plus CHOP in Newly Diagnosed PTCL

This is single-arm phase I/II study designed to evaluate the safety and efficacy of golcadotinib in combination with the CHOP regimen for patients with newly diagnosed peripheral T-cell lymphoma (PTCL). The study adopts a two-stage design, consisting of a Phase I and a Phase II parts. In the phase I study, a standard "3+3" design will be used. The primary endpoints of the Phase I study are the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D). The primary endpoint of the Phase II study is the complete response rate (CRR) of the golcadotinib combined with CHOP regimen.

Linperlisib in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma

This phase Ib/II, single arm, open label, multicenter study is conducted to evaluate the efficacy and safety of linperlisib in combination with CHOP for newly diagnosed PTCL patients, and explore the reasonable dosage of linperlisib when combined with CHOP regimen.

A Study of SHR2554 With Chemotherapy in Treatment-naïve Patients With Peripheral T-cell Lymphoma

The study is being conducted to evaluate the safety and efficacy of SHR2554 with CHOP/CHOEP in treatment- naïve peripheral T-cell lymphoma.

Circulating Tumor DNA in Peripheral T-cell Lymphomas

The aim of this study is to evaluate the feasibility of circulating tumor DNA (ctDNA) measurement in blood plasma for the applicability in prognostication, treatment evaluation and measurable residual disease (MRD) surveillance in a cohort of patients with newly diagnosed or relapsed/refractory peripheral T-cell lymphomas (PTCL).