Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Marginal Zone Lymphoma

B-cell Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Rituximab

Complement System Proteins

Antineoplastic Agents, Immunological

Immunologic Factors

10-20 mg (1-2 ml) rituximab once a week for 4 weeks; followed by 10-20 mg (1-2 ml) rituximab monthly per six months

intralesional rituximab

patients in PD or SD during or after administration of 6 doses monthly rituximab will be administered the same dose of intralesional rituximab supplemented by autologous serum

supplemental autologous serum

Andrés JM Ferreri, MD

Phase II, monocentric, open label study to assess safety and activity of intralesional Rituximab for the treatment of indolent CD20+ lymphoma of conjunctiva.

Preliminary data suggest intralesional rituximab is able to revert resistance to systemic rituximab in patients with CD20+ indolent lymphoma of the conjunctiva, and the addition of autologous serum seems to exhibit a synergistic effect on tumor regression. These two main aspects will be assessed in this trial.

Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma

Phase II Study on Activity and Tolerability of Intralesional Rituximab in Patients With Relapsed or Refractory CD20+ Indolent Lymphomas of Conjunctiva; Activity of Supplemental Autologous Serum in Patients Not Responsive to Rituximab Alone

assessment of safety of intralesional rituximab in terms of incidence of \>/= G4 adverse events during the experimental treatment

assessment of activity of intralesional rituximab in terms of overall partial and complete response and duration of response

Andres J. M. Ferreri

Pharmaceutical Solutions

Pembrolizumab

Immune Checkpoint Inhibitors

Cycle 1 (21 days cycle):

Rituximab: 375 mg/m2 day 1, 8, 15 Pembrolizumab: 200 mg IV fixed dose day 2

Cycle 2-18 (21 days cycle) or until progression or non-tolerable toxicity:

Rituximab: 375 mg/m2 day 1 every second cycle Pembrolizumab: 200 mg IV fixed dose day 1

100 mg concentrate for solution for infusion

100 mg/ 4mL concentrate for solution for infusion

Ivonne Kriebisch

Peter Neumeister, Univ. Prof.

Markus Raderer, Prof. Dr.

Christian Buske, Prof.Dr.

Corinna Leng, Dr.

Mathias Hänel, PD Dr.

Gabriele Prange-Krex, Dr. med.

Ullrich Graeven, Prof. Dr.

Simon Heidegger, PD Dr.

Rüdiger Liersch, PD Dr.

Andreas Voss

Tobias Gaska, Dr. med.

Thomas Südhoff, Prof. Dr.

Gerhard Puchtler, Dr.

Alexander Stehle, Dr.

Christian Buske, Prof. Dr.

For marginal zone lymphoma (MZL) Rituximab in combination with conventional chemotherapy is widely used for those patients who fail local therapy or do not qualify for such. Depending on the MZL subtype Rituximab/chemotherapy is able to induce in part long remissions, but does not prevent relapse later on. In addition, chemotherapy associated toxicity is often problematic in MZL patients, who are mostly of advanced age. Thus, chemotherapy-free approaches are highly attractive for this patient group. Rituximab single agent is a widely used chemotherapy-free approach in MZL, but was significantly inferior compared to Rituximab/chlorambucil in a large randomized prospective clinical trial in treatment naïve MZL with a CR rate of 55.8% vs. 78.8%, respectively (P \< 0.001). Thus, it is the major aim to develop chemotherapy-free approaches for MZL, which approach or surpass efficacy of rituximab/chemotherapy combinations, but avoid chemotherapy associated toxicities.

Checkpoint inhibitors such as Pembrolizumab have revolutionized cancer treatment and have also shown first encouraging results in Non-Hodgkin lymphomas. Based on these observations it is the aim of this study to test the toxicity and efficacy of Pembrolizumab in combination with the anti-CD20 antibody Rituximab in patients with newly diagnosed or relapsed MZL in need of treatment, who are not eligible or failed local therapy, following the assumption that this novel chemotherapy-free combination is significantly more efficient than Rituximab single agent therapy and at least as efficient as rituximab/chemotherapy, but avoids chemotherapy-related toxicity.

For marginal zone lymphoma (MZL) Rituximab in combination with conventional chemotherapy is widely used for those patients who fail local therapy or do not qualify for such. Depending on the MZL subtype Rituximab/chemotherapy is able to induce in part long remissions, but does not prevent relapse later on. In addition, chemotherapy associated toxicity is often problematic in MZL patients, who are mostly of advanced age. Thus, chemotherapy-free approaches are highly attractive for this patient group. Rituximab single agent is a widely used chemotherapy-free approach in MZL, but was significantly inferior compared to Rituximab/chlorambucil in a large randomized prospective clinical trial in treatment naïve MZL with a CR rate of 55.8% vs. 78.8%, respectively (P \< 0.001). Thus, it is the major aim to develop chemotherapy-free approaches for MZL, which approach or surpass efficacy of rituximab/chemotherapy combinations, but avoid chemotherapy associated toxicities.

Checkpoint inhibitors such as Pembrolizumab have revolutionized cancer treatment and have also shown first encouraging results in Non-Hodgkin lymphomas. Based on these observations it is the aim of this study to test the toxicity and efficacy of Pembrolizumab in combination with the anti-CD20 antibody Rituximab in patients with newly diagnosed or relapsed MZL in need of treatment, who are not eligible or failed local therapy, following the assumption that this novel chemotherapy-free combination is significantly more efficient than Rituximab single agent therapy and at least as efficient as rituximab/chemotherapy, but avoids chemotherapy-related toxicity.

The objective of the trial is to test the efficacy and toxicity of treatment with Pembrolizumab and Rituximab in patients with MZL in need of treatment, who have failed or are not eligible for local therapy or relapsed. For efficacy the rate of complete remissions (according to the GELA criteria for gastric MALT or to the Cheson 2007 criteria for nodal and splenic MZL) after end of treatment (18 cycles) will be primarily analyzed. For toxicity assessment treatment associated adverse events, quality of life and cumulative incidence of secondary malignancies will be documented.

This study is a European multicenter, single-arm, open-label, phase II trial of 18 cycles of Pembrolizumab and Rituximab in patients aged ≥ 18 years with previously untreated or relapsed MZL in need of treatment.

Primary endpoint is the complete response (CR rate (CRR) determined after end of treatment (18 cycles).

The study flow will be as follows:

* Previously untreated or relapsed patients will be screened for eligibility for the trial. If the patient is eligible for the study, the patient will be registered before the first cycle of treatment.
* Patients who progress at any time point during treatment are considered as treatment failure. They will be followed up for overall survival until end of follow up period or death.
* Patients, who achieve at least a SD after treatment will be followed up for response until progression/relapse and for overall survival until death.

It is expected that a total of 56 patients at approximately 15 investigator sites in Germany and 3 centers in Austria will be registered. Every patient will receive treatment over a time period of 18 cycles (each cycle lasts 3 weeks). Subsequently, patients will be monitored every 3 months for 2 additional years, subsequently every 6 months for three additional years. The follow-up phase will be shorter than 5 years if End of Study is reached before this time period.

Pembrolizumab in MarginalzoneLymphoma A MULTICENTER OPEN LABEL SINGLE-ARM PHASE II STUDY

Pembrolizumab in Marginalzone Lymphoma A MULTICENTER OPEN LABEL SINGLE-ARM PHASE II STUDY

CR rate (CRR) after end of treatment (18 cycles)

The response rates are evaluated 4 weeks after the end of treatment

Best response is determined in the time interval from the start of induction therapy to end of follow-up.

Time to best response is defined as the time from the start of induction to best response the patient achieves (CR, PR)

Time to first response is defined as the time from the start of induction to first response (CR, PR)

Progression free survival (PFS) is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment.

Time to treatment failure is defined as the time of registration to discontinuation of therapy for any reason including death from any cause, progression, toxicity or add-on of new anti-cancer therapy. Patients alive without treatment failure are censored at the latest tumor assessment date.

Duration of response will be calculated in patients with response (CR, PR) to induction from end of induction to the date of progression, relapse or death from any cause. Patients alive without progression and relapse will be censored at the latest tumor assessment date or the stopping date.

Cause specific survivial is defined as the period from the induction registration to death from lymphoma or lymphoma related cause; death unrelated to MZL is considered as a competing event.

Overall survival is defined as the period from the induction registration to death from any cause. Patients who have not died until the time of the analysis will be censored at their last contact date.

Quality of life will be measured by the FACT Lym before start of treatment and during trial participation.

X-act Cologne Clinical Research GmbH

Zentrum für Klinische Studien Ulm

Merck Sharp & Dohme LLC

Celltrion Healthcare Co., LTD

University of Ulm

Prof. Dr.

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, Large B-Cell, Diffuse

Mantle Cell Lymphoma

Follicular Lymphoma

Diffuse Large B-Cell Lymphoma

Immunomodulating Agents

Veltuzumab

once weekly intravenous dosing for 4 weeks

veltuzumab

William Wegener, MD, PhD

This study is being done to assess the safety and tolerance of different doses of humanized hA20 in patients with NHL.

Safety Study of Different Doses of hA20 (Veltuzumab) in CD20+ Non-Hodgkin's Lymphoma

A Phase I Study of Immunotherapy With hA20 Administered Once Weekly for 4 Consecutive Weeks in Patients With CD20+ Non- Hodgkin's Lymphoma

Gilead Sciences

Anti-Infective Agents

Clarithromycin

Anti-Bacterial Agents

Enzyme Inhibitors

Cytochrome P-450 CYP3A Inhibitors

Cytochrome P-450 Enzyme Inhibitors

2 g/day clarithromycin (once a day) for 14 days followed by 7 days interval to be repeated for 4 cycles in total

clarithromycin, oral, high dose

This is a prospective, phase II study on the activity and tolerability of high dose (2 g/day) oral clarithromycin for the treatment of relapsed or refractory extranodal marginal zone lymphoma.

A 6-month regimen of oral clarithromycin has been associated with a 35% ORR in patients with relapsed/refractory marginal zone B-cell lymphoma. Responses were more common among patients with conjunctival lymphoma. This could be explained at least in part by the elimination of clarithromycin by tears, suggesting that a higher tumor bioavailability of this antibiotic could result in a higher activity. Thus, a higher dose of clarithromycin could be associated with a higher tumor bioavailability in tissues other than the conjunctiva.

Salvage Therapy With High Dose Oral Clarithromycin in Relapsed or Refractory Extranodal Marginal Zone Lymphoma

Phase II Clinical Trial on the Activity of Salvage Therapy With High Dose Oral Clarithromycin in Patients With Relapsed or Refractory Extranodal Marginal Zone Lymphoma

evaluation of activity in terms of global responses, complete responses and duration of responses

Amino Acids

Tyrosine Kinase Inhibitors

Ibrutinib

Protein Kinase Inhibitors

Tyrosine

ibrutinib

Isaiah Dimery, MD

Phase 2, open-label, non-randomized, monotherapy study to evaluate the safety and efficacy of ibrutinib in subject with relapsed/refractory Marginal Zone Lymphoma (MZL).

Ibrutinib is a first-in-class, potent, orally administered covalent inhibitor of Bruton's tyrosine kinase (BTK). Inhibition of BTK blocks downstream B-cell receptor (BCR) signaling pathways and thus prevents B-cell proliferation. In vitro, ibrutinib inhibits purified BTK and selected members of the kinase family with 10-fold specificity compared with non-BTK kinases. Phase 1 and 2 studies of ibrutinib in B-cell malignancies demonstrate modest toxicity and significant single agent activity in a variety of B-cell malignancies, including NHL.

Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma

A Multicenter, Open-Label, Phase 2 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects With Relapsed/Refractory Marginal Zone Lymphoma

ORR is defined as the proportion of subjects who achieved complete response (CR), partial response (PR). Response criteria are as outlined in the International Working Group Criteria for NHL, Cheson (2007), with disease assessments performed by an independent review committee (IRC).

Per Cheson:

CR is defined as disappearance of all evidence of disease. PR is defined as regression of measurable disease and no new sites.

The DOR analyses is performed on the subset of subjects that achieve CR or PR as determined by IRC. DOR is calculated as the duration of time from the date of first response to the date of progression or death due to any cause.

Janssen Research & Development, LLC

Pharmacyclics LLC.

For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma	NCT01514344	Ocular Adnexal ...	intralesional r... supplemental au...	18 Years -	IRCCS San Raffaele
Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma	NCT01514344	Ocular Adnexal ...	intralesional r... supplemental au...	18 Years -	IRCCS San Raffaele
Pembrolizumab in MarginalzoneLymphoma A MULTICENTER OPEN LABEL SINGLE-ARM PHASE II STUDY	NCT04268277	Marginal Zone L...	Rituximab Pembrolizumab	18 Years -	University of Ulm
Safety Study of Different Doses of hA20 (Veltuzumab) in CD20+ Non-Hodgkin's Lymphoma	NCT00596804	Non-Hodgkin's L... Lymphoma, Diffu... Lymphoma, Diffu...	veltuzumab	18 Years -	Gilead Sciences
Salvage Therapy With High Dose Oral Clarithromycin in Relapsed or Refractory Extranodal Marginal Zone Lymphoma	NCT01516606	Lymphoma	clarithromycin,...	18 Years -	IRCCS San Raffaele
Safety Study of Different Doses of hA20 (Veltuzumab) in CD20+ Non-Hodgkin's Lymphoma	NCT00596804	Non-Hodgkin's L... Lymphoma, Diffu... Lymphoma, Diffu...	veltuzumab	18 Years -	Gilead Sciences
Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma	NCT01980628	Marginal Zone L... B-cell Lymphoma	ibrutinib	18 Years -	Pharmacyclics LLC.
Safety Study of Different Doses of hA20 (Veltuzumab) in CD20+ Non-Hodgkin's Lymphoma	NCT00596804	Non-Hodgkin's L... Lymphoma, Diffu... Lymphoma, Diffu...	veltuzumab	18 Years -	Gilead Sciences
Safety Study of Different Doses of hA20 (Veltuzumab) in CD20+ Non-Hodgkin's Lymphoma	NCT00596804	Non-Hodgkin's L... Lymphoma, Diffu... Lymphoma, Diffu...	veltuzumab	18 Years -	Gilead Sciences

Spots Global Cancer Trial Database for malt

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

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