Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Anti-Infective Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Prednisone

Rituximab

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Participants in the dose escalation/confirmation phase receive a dose level of zilovertamab vedotin (from 1.5 mg/Kg up to 2.5 mg/Kg) plus 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar (truxima) administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 8 cycles (up to approximately 5.5 months). Participants also receive 100 mg prednisone or prednisolone per day during Days 1-5 of each 21-day cycle for up to 8 cycles (up to approximately 5.5 months).

Participants in the efficacy expansion phase receive the RP2D of zilovertamab vedotin plus 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar (truxima) administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 8 cycles (up to approximately 5.5 months). Participants also receive 100 mg prednisone or prednisolone per day during Days 1-5 of each 21-day cycle for up to 8 cycles (up to approximately 5.5 months).

Zilovertamab Vedotin

Rituximab Biosimilar

IV or oral administration (per local guidelines)

Toll Free Number

Study Coordinator

Medical Director

This study consists of a dose escalation/confirmation phase and an efficacy expansion phase. The dose escalation/confirmation phase is to determine the safety and tolerability and establish a preliminary recommended Phase 2 dose (RP2D) of zilovertamab vedotin when administered in combination with R-CHP in participants with DLBCL who have received no prior treatment for their disease. The efficacy expansion phase is to determine the efficacy of the RP2D of zilovertamab vedotin when administered in combination with R-CHP in participants with DLBCL who have received no prior treatment for their disease.

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Cyclophosphamide, Doxorubicin, and Prednisone Plus Rituximab or Rituximab Biosimilar (Truxima) (R-CHP) in Participants With Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-007)

A Multicenter, Open-label, Phase 2 Dose Escalation and Confirmation, and Efficacy Expansion Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP in Participants With DLBCL (waveLINE)

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

DLTs will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 and are defined as any drug-related adverse event (AE) observed during the DLT evaluation period (e.g. Cycle 1) that results in a change to a given dose or a delay in initiating the next cycle. The number of participants with DLTs in Cycle 1 will be reported.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE will be reported.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be reported.

CRR is defined as the percentage of participants who achieve a Complete Response (CR) per Lugano response criteria \[Cheson, B. D., et al 2014\] for malignant lymphoma as assessed by the investigator. Assessment includes anatomic imaging with computed tomography (CT) or magnetic resonance imaging (MRI), metabolic imaging with positron emission tomography (PET), and clinical findings including physical examination and bone marrow biopsy results. The percentage of participants with CRR will be reported.

ORR is defined as the percentage of participants who achieve a Complete Response (CR) or Partial Response (PR) per Lugano response criteria \[Cheson, B. D., et al 2014\] for malignant lymphoma as assessed by the investigator. Assessment includes anatomic imaging with computed tomography (CT) or magnetic resonance imaging (MRI), metabolic imaging with positron emission tomography (PET), and clinical findings including physical examination and bone marrow biopsy results. The percentage of participants with ORR will be reported.

For participants who demonstrate a confirmed Complete Response (CR) or Partial Response (PR) per Lugano response criteria \[Cheson, B. D., et al 2014\] for malignant lymphoma, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. CR and PR assessment includes anatomic imaging with computed tomography (CT) or magnetic resonance imaging (MRI), metabolic imaging with positron emission tomography (PET), and clinical findings including physical examination and bone marrow biopsy results. DOR as assessed by the investigator will be reported.

Merck Sharp & Dohme LLC

Indolent B Cell Lymphoma

Interferons

Antiviral Agents

1. Induction phase:

1. Rituximab: 375mg / m2, ivd, d1;
2. Pegylated interferon α-2b: 135 μg (500,000 U), H, d1, 8 Repeated every 21 days, Maximum 6 cycles 2. Maintenance phase:

1) Rituximab: 375mg / m2, ivd, d1; 2) Pegylated interferon α-2b: 135 μg (500,000 U), H, d1,30 Repeated every 2 months, Maximum 12 cycles

To evaluate the short-term objective efficacy of HLX01 combined with Pegylated Interferon α-2b in patients with advanced idolent B-cell lymphoma.

Pegylated Interferon α-2b

Huiqiang Huang, Professor

Yan Gao, Professor

HuiQiang Huang

Ye Cao, Professor

A phase 2 open label study to evaluate safety and activity of Rituximab(HLX01) in combination with Pegylated interferon α-2b in patients with newly diagnosed advanced indolent B-cell lymphoma.

Indolent B-cell lymphomas (iBCL), including follicular lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL, including Waldenström macroglobulinemia), and some cases of mantle cell lymphoma (MCL), disproportionally affect older individuals.Treatment options are heterogeneous, varying from watchful waiting to intensive combination therapy. Historically, rituximab based regimens have been used as standard immunochemotherapy for iBCL.Use of immunotherapy for indolent lymphoma had been advocated for many years and several studies reported benefit with interferon (IFN) in combination with chemotherapy or rituximab. The positive rate of HBsAg in B-cell NHL is about 30% in China.Pegylated interferon contribute to convert HBsAg to negative. We aim to evaluate safety and activity of Rituximab(HLX01) in combination with Pegylated interferon α-2b in patients with newly diagnosed advanced iBCL and HBsAg clearance rate of hepatitis B patients.

Rituximab and Pegylated Interferon α-2b in Patients With Indolent B-cell Lymphoma

Safety and Activity of Rituximab(HLX01) in Combination With Pegylated Interferon α-2b in Patients With Newly Diagnosed Advanced Indolent B-cell Lymphoma: a Single-arm, Multicenter, Phase 2 Study

Short-term effcacy according to Lugano 2014 Malignant Lymphoma Evaluation Criteria

Evaluate HBsAg clearance rate and positive rate of anti-Hbs antibody

PFS is defined as the time from the treatment date to the date of disease

Quality of Life evaluation to end of study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Zilovertamab Vedotin (MK-2140) in Combination With Cyclophosphamide, Doxorubicin, and Prednisone Plus Rituximab or Rituximab Biosimilar (Truxima) (R-CHP) in Participants With Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-007)	NCT05406401	Lymphoma, Large...	Zilovertamab Ve... Cyclophosphamid... Doxorubicin Rituximab Rituximab Biosi... Prednisone Prednisolone	18 Years -	Merck Sharp & Dohme LLC
A Study of Zilovertamab Vedotin (MK-2140) in Combination With Cyclophosphamide, Doxorubicin, and Prednisone Plus Rituximab or Rituximab Biosimilar (Truxima) (R-CHP) in Participants With Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-007)	NCT05406401	Lymphoma, Large...	Zilovertamab Ve... Cyclophosphamid... Doxorubicin Rituximab Rituximab Biosi... Prednisone Prednisolone	18 Years -	Merck Sharp & Dohme LLC
A Study of Zilovertamab Vedotin (MK-2140) in Combination With Cyclophosphamide, Doxorubicin, and Prednisone Plus Rituximab or Rituximab Biosimilar (Truxima) (R-CHP) in Participants With Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-007)	NCT05406401	Lymphoma, Large...	Zilovertamab Ve... Cyclophosphamid... Doxorubicin Rituximab Rituximab Biosi... Prednisone Prednisolone	18 Years -	Merck Sharp & Dohme LLC
Rituximab and Pegylated Interferon α-2b in Patients With Indolent B-cell Lymphoma	NCT04246359	Lymphoma, B-Cel...	Rituximab Biosi... Pegylated Inter...	18 Years - 80 Years	Sun Yat-sen University

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