Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Follicular Lymphoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Patients will receive a lymphodepletion chemotherapy with fludarabine plus cyclophosphamide for three consecutive days(Day -5 to Day -3) before infusion of CD19-targeted chimeric antigen receptor T-cell (CD19 CAR-T). Patients will receive the CD19 CAR-T(also known as PL001) infusion on Day 0.

Drug: Fludarabine

patients will receive a lymphodepletion chemotherapy with Fludarabine 25 mg/m2/day IV for 3 days on Day-5 to Day-3(a safe window for a small subset of patients will be D -7 to D -3).

Drug: Cyclophosphamide

patients will receive a lymphodepletion chemotherapy with cyclophosphamide 300 mg/m2/day IV for 3 dys Day-5 to Day-3(a safe window for a small subset of patients will be D -7 to D -3).

Biological: CD19 CAR-T

CD19 CAR-T cells will be administered using as a single dose at 0.1-9\*10\^6 cells/kg on Day 0 after completion of the lymphodepletion chemotherapy. The body weight calculated for PL001 dose is the actual body weight on the day of leukapheresis.

CD19-targeted chimeric antigen receptor T-cell

Cherry Lo, MSC

Shyh-Shin Chiou

Jyh-Pyng Gau

Shang-Ju Wu

Liang-Tsai Hsiao

Chen-Lung Lin, MD

This is a multiple center, non-randomized, open-label, phase 1/2 study. The primary objective of Phase 1 is to evaluate the safety of PL001 and find the recommended Phase 2 dose (RP2D). The objective of Phase 2 is to evaluate the safety and efficacy of CD19 CAR-T(known as PL001).

Cluster of differentiation (CD) 19 chimeric antigen receptor T-cell (CAR-T) has been a very promising treatment option for multiple types of B-cell lymphoma. Kymriah® (tisagenlecleucel, Novartis) and Yescarta® (axicabtagene ciloleucel, Gilead) were licensed by the United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA) in 2017 to treat relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), diffuse large B-cell lymphoma (DLBCL), and High-grade B-cell lymphoma (HGBCL). A third anti-CD19 CAR-T product, Tecartus (brexucabtagene autoleucel, Gilead) was approved by the US FDA for relapsed and refractory mantle cell lymphoma (MCL) in July 2020. In February 2021, another product, Breyanzi® (lisocabtagene maraleucel, Juno Therapeutics, Inc.), was approved by the US FDA for relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, Primary mediastinal large B cell lymphoma (PMLBCL), and Gr. 3b FL.

Currently, in Taiwan, no CD19 CAR-T therapies are available commercially.This Phase 1/Phase 2 study will test PL001, a CD19 CAR-T therapy manufactured by Pell Bio-Med Technology Co., Ltd., as a monotherapy for relapsed or refractory B-cell lymphoma. The Phase 1 of the study will be conducted to establish a dose range that is well tolerated by the majority of patients and to provide a safety profile of PL001 in the target patient population. The results of the Phase 1 of the study will recommend the dose selection for the Phase 2 of the study. Phase 2 of the study will assess the efficacy and safety of PL001 in patients with relapsed or refractory B cell lymphoma.

This study is a multiple-center, non-randomized, open-label, phase 1/2 study. Lymphodepletion chemotherapy (intravenous infusion of fludarabine plus cyclophosphamide will be administered for 3 consecutive days before the day of PL001 dosing (Day 0) and should take place within Day -5 to Day -3 (a safe window for a small subset of patients will be D -7 to D -3). This study will test two dose levels of PL001, dose level 1 and dose level 2. In Phase 1, doses will be tested in the modified "3 + 3" design initiating with dose level 1. The primary objective of Phase 1 is to assess the safety of PL001 and find the recommended phase 2 dose. Phase 2 expansion cohort will receive PL001 at the recommended dose determined in Phase 1. Efficacy evaluations using computed tomography (CT) and positron emission tomography (PET) will be performed at 1, 3, 6, 9, and 12 months.

Phase 1/2 Study of CD19 Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) for Relapsed or Refractory B-cell Lymphoma

A Phase 1/2 Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Efficacy of CD19-targeted Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) Therapy in Patients With Relapsed or Refractory B-cell Lymphoma

Persistence of PL001 in peripheral blood using flow cytometry

PL001 transgene levels by qPCR (quantitative polymerase chain reaction) in peripheral blood

Rates for successful production and infused patients

Cytokine concentrations in peripheral blood

Dose-limiting toxicities through 30 days after PL001 infusion

The BOR comprising of patients with partial and complete responses according to Lugano criteria assessed by the Independent Central Review.

Treatment-related adverse events assessed by CTCAE v 5.0. Overall grading of Cytokine Release Syndrome, immune effector cell associated neurotoxicity syndrome, based on the American Society for Transplantation and Cellular Therapy (ASTCT) criteria.

The BOR of patients with partial and complete responses according to Lugano criteria assessed by the Investigator.

Median duration of response (mDOR) measured from the time of initial documented response (complete response or partial response) until documented disease progression or death.

Progression-free survival (PFS) defined as the time from the infusion of PL001 until objective disease progression or death, whichever occurs first.

Overall survival (OS) defined as the time from the infusion of PL001 until death from any cause.

Change in the health-related quality of life (HRQoL) by FACT-Lym (the Functional Assessment of Cancer Therapy-Lymphoma)® version 4

Pell Bio-Med Technology Co., Ltd.

DISEASE

This is a retrospective, multicenter study designed to collect data on the diagnostic, therapeutic management and outcome of patients diagnosed with primary mediastinal lymphoma who have progressed or relapsed with central nervous system (CNS) involvement.

Through this study, an international data set from 6 different countries will be collected on clinical factors, anti-lymphoma therapy administered alone or in conjunction with CNS prophylaxis, re-biopsy site information when available, dose intensity of lymphoma therapy received at recurrence, and patient outcome.

In addition, to better characterize the pathologic features of this rare entity, a central pathologic review of the initial diagnosis and, if available, histologic confirmation of recurrence will be performed.

CNS Involvement in Primary Mediastinal Large B-Cell Lymphoma (PMLBCL)

Retrospective Multicenter International Study on Prognostic Factors, Management And Outcome Of Primary Mediastinal Large B-Cell Lymphoma (PMLBCL) Patients With Central Nervous System (Cns) Involvement.

to describe the PMLBCL characteristics at diagnosis and at CNS relapse ( first relapse or second and subsequent recurrences) and the treatment received

to describe the median time to CNS relapse

to define prognostic factors of outcome of CNS relapse in PMLBCL patients

to correlate treatment strategy with survival end-points

to evaluate the Progression Free Survical ( PFS) after CNS events

to evaluate Overall Survival ( OS) after CNS relapse

to central pathological reviewed the initial diagnosis and the relapse and to correlate biological and molecular factors with CNS recurrence

IRCCS San Raffaele

Oncologist

Immunomodulating Agents

Brentuximab Vedotin

Antineoplastic Agents, Immunological

Immunotoxins

Immunoconjugates

Immunologic Factors

This is a single-arm, open-label, multicenter, Phase 2 clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory PMLBCL who have previously received a first line of treatment with chemotherapy or immunotherapy.20 patients will be treated in this study and All patients will receive 1.8 mg/kg Brentuximab vedotin administered as a single outpatient IV infusion on Day 1 of each 21-day treatment cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better as assessed by investigator should receive a minimum of 8, but no more than 16 cycles of study treatment.

Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle.

Pier Luigi Zinzani, Prof.

Study Objectives Primary:

• To determine the antitumor efficacy of single-agent Brentuximab vedotin (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in patients with relapsed or refractory primary mediastinal large B-cell lymphoma.

Secondary:

* To assess duration of tumor control, including duration of response and progression-free survival
* To assess survival
* To assess the safety and tolerability of Brentuximab vedotin

Additional:

• To assess disease-related symptoms

Number of Planned Patients 20 patients will be enrolled in this study. Duration of the study The study duration is 18 months for enrollment and 2 years for the follow-up.

Study Population Eligible patients are those with relapsed or refractory primary mediastinal large B-cell lymphoma. Patients must also have histologically-confirmed CD30-positive disease, fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate hematologic, kidney, and liver function.

Eligible patients must not previously have been treated with Brentuximab vedotin or previously received an allotransplant. In addition, patients must not have congestive heart failure, known cerebral/meningeal disease, or any active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to first study dose.

Study Design This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory primary mediastinal large B-cell lymphoma.

Brentuximab vedotin will be administered as a single IV infusion on Day 1 of each 21-day cycle. Measures of anti-cancer activity will be assessed using the revised response criteria for malignant lymphoma. CT scans (chest, neck, abdomen, and pelvis) will be performed at baseline and Cycles 2, 4, 7, 10, 13, and 16 and PET scans will be done at baseline and Cycles 4 and 7. Patients will have an EOT assessment 30 ± 7 days after receiving their final dose of study drug. Long-term follow-up assessments (including survival and disease status information) will be performed every 12 weeks until either patient death or study closure, whichever occurs first. Patients who discontinue study treatment with stable disease or better will have CT scans done every 12 weeks until disease progression.

Test Product, Dose, and Mode of Administration Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle.

Number of Planned Patients 20 patients will be enrolled in this study. Duration of Treatment Brentuximab vedotin will be administered as a single IV infusion on Day 1 of each 21-day cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better should receive a minimum of 8, but no more than 16 cycles of study treatment.

Duration of the study The study duration is 18 months for enrollment and 2 years for the follow-up. Efficacy Assessments Treatment response will be assessed by tumor imaging (spiral CT of neck, chest, abdomen, pelvis and PET scans) performed at protocol-specified timepoints. Determination of antitumor efficacy will be based on objective response assessments made according to the Revised Response Criteria for Malignant Lymphoma. Clinical response of progressive disease (PD), stable disease (SD), partial remission (PR), or complete remission (CR) will be determined at each assessment. Responses will be determined by investigator.

Safety Assessments Assessment of safety during the course of this study will consist of the surveillance and recording of adverse events (AEs), recording of concomitant medication and measurements of protocol-specified physical examination findings and laboratory tests.

A Study of SGN-35 (Brentuximab Vedotin) of Patients With Relapsed or Refractory PMLBCL

A Phase II Study of SGN-35 (Brentuximab Vedotin) of Patients With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (PMLBCL)

The antitumor efficacy of single-agent Brentuximab vedotin (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in patients with relapsed or refractory primary mediastinal large B-cell lymphoma was determined using Cheson BD, Pfistner B, Juweid ME, et al. "Revised response criteria for malignant lymphoma". J Clin Oncol. 2007 Feb 10;25(5):579-586.Treatment response was assessed by dedicated spiral CT scan of neck, chest, neck, abdomen, and pelvis and PET scans performed at protocol-specified time points. Clinical response of progressive disease (PD), stable disease (SD), partial remission (PR), or complete remission (CR) will be determined at each assessment.

Fondazione Italiana Linfomi - ETS

We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.

This is a single-arm, open-label, multicenter, Phase 2 clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory PMLBCL who have previously received a first line of treatment with chemotherapy or immunotherapy.20 patients will be treated in this study and All patients will receive 1.8 mg/kg Brentuximab vedotin administered as a single outpatient IV infusion on Day 1 of each 21-day treatment cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better as assessed by investigator should receive a minimum of 8, but no more than 16 cycles of study treatment.

Brentuximab Vedotin: Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle.

Vial for IV Infusion

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Italy

Region of Enrollment

MD Vittorio Stefoni

Quick PD

PD after 1 cycle

PD after 2 cycle

SAE not related to drug

Trial was closed due to drug inefficacy on 14/Jul/2016 (last enrollment on 30/Jun/2015). Details in the Outcome Measure Data Table.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase 1/2 Study of CD19 Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) for Relapsed or Refractory B-cell Lymphoma	NCT05326243	Diffuse Large B... Primary Mediast... Large B-cell Ly... Follicular Lymp... Follicular Lymp...	CD19-targeted c...	14 Years - 70 Years	Pell Bio-Med Technology Co., Ltd.
CNS Involvement in Primary Mediastinal Large B-Cell Lymphoma (PMLBCL)	NCT05856708	Primary Mediast...	DISEASE	18 Years -	IRCCS San Raffaele
Phase 1/2 Study of CD19 Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) for Relapsed or Refractory B-cell Lymphoma	NCT05326243	Diffuse Large B... Primary Mediast... Large B-cell Ly... Follicular Lymp... Follicular Lymp...	CD19-targeted c...	14 Years - 70 Years	Pell Bio-Med Technology Co., Ltd.
A Study of SGN-35 (Brentuximab Vedotin) of Patients With Relapsed or Refractory PMLBCL	NCT02423291	Primary Mediast...	Brentuximab Ved...	18 Years -	Fondazione Italiana Linfomi - ETS

Spots Global Cancer Trial Database for pmlbcl

Every month we try and update this database with for pmlbcl 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 pmlbcl

Every month we try and update this database with for pmlbcl 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 pmlbcl 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.