Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Digestive System Diseases

Rare Diseases

Lymphoma

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Stomach Neoplasms

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Lymphosarcoma

Marginal Zone Lymphoma

B-cell Lymphoma

Stomach Cancer

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Rituximab

Antineoplastic Agents, Immunological

Immunologic Factors

Involved Site Radiation Therapy

Rong Lu

Yu Zhu

This project proposes to establish a prospective, multicenter, randomized, controlled clinical study to compare the safety and efficacy of Intralesional Rituximab Injection versus Involved Site Radiation Therapy for the treatment of primary ocular adnexal MALT lymphoma. The aim is to provide high-level clinical evidence for the treatment of ocular adnexal MALT lymphoma and to offer patients treatment options that have fewer complications and comparable therapeutic effects.

RCT on Intralesional Rituximab Injection Versus ISRT in Ocular Adnexal MALT Lymphoma

Safety and Efficacy of Intralesional Rituximab Injection Versus Involved Site Radiation Therapy in Primary Ocular Adnexal MALT Lymphoma: a Multicenter Randomized Controlled Trial

Zhongshan Ophthalmic Center, Sun Yat-sen University

Professor, MD, PhD

Hodgkin Disease

Hodgkin Lymphoma

Pembrolizumab

Immune Checkpoint Inhibitors

Following a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.

pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.

Alison Moskowitz, MD

Joachim Yahalom, MD

Craig Moskowitz, MD

Jakob Svoboda, MD

This study is being done to test the safety and effectiveness of pembrolizumab followed by radiation therapy in Hodgkin lymphoma.

The purpose of this study is to determine how effective combining the research drug, pembrolizumab, with a targeted form of radiation therapy known as involved site radiotherapy can be in patients with relapsed or refractory early stage classical Hodgkin lymphoma. The goal is to see whether this treatment strategy can cure a significant number of patients with relapsed or refractory early stage classical Hodgkin lymphoma while avoiding the toxicity of either a large radiation field or further chemotherapy and stem cell transplant.

This phase II study will use an optimal Simon two-stage design.

Pembrolizumab and Involved Site Radiation Therapy for Early Stage Relapsed or Primary Refractory Hodgkin Lymphoma

Memorial Sloan Kettering Cancer Center

RCT of Intralesional Rituximab Injection Versus Involved Site Radiation Therapy in Ocular Adnexal MALT Lymphoma

Safety and Efficacy of Intralesional Rituximab Injection Versus Involved Site Radiation Therapy in Primary Ocular Adnexal MALT Lymphoma: a Multicenter Non-Inferiority Randomized Controlled Trial

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
RCT on Intralesional Rituximab Injection Versus ISRT in Ocular Adnexal MALT Lymphoma	NCT06190301	Primary Ocular ...	Rituximab Involved Site R...	18 Years - 75 Years	Zhongshan Ophthalmic Center, Sun Yat-sen University
Pembrolizumab and Involved Site Radiation Therapy for Early Stage Relapsed or Primary Refractory Hodgkin Lymphoma	NCT03179917	Hodgkin Lymphom...	Pembrolizumab Involved Site R...	12 Years -	Memorial Sloan Kettering Cancer Center
RCT of Intralesional Rituximab Injection Versus Involved Site Radiation Therapy in Ocular Adnexal MALT Lymphoma	NCT06064344	Primary Ocular ...	Rituximab Involved Site R...	18 Years - 75 Years	Zhongshan Ophthalmic Center, Sun Yat-sen University
RCT of Intralesional Rituximab Injection Versus Involved Site Radiation Therapy in Ocular Adnexal MALT Lymphoma	NCT06064344	Primary Ocular ...	Rituximab Involved Site R...	18 Years - 75 Years	Zhongshan Ophthalmic Center, Sun Yat-sen University
Pembrolizumab and Involved Site Radiation Therapy for Early Stage Relapsed or Primary Refractory Hodgkin Lymphoma	NCT03179917	Hodgkin Lymphom...	Pembrolizumab Involved Site R...	12 Years -	Memorial Sloan Kettering Cancer Center
RCT on Intralesional Rituximab Injection Versus ISRT in Ocular Adnexal MALT Lymphoma	NCT06190301	Primary Ocular ...	Rituximab Involved Site R...	18 Years - 75 Years	Zhongshan Ophthalmic Center, Sun Yat-sen University

Spots Global Cancer Trial Database for involved site radiation therapy