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PD-1 Inhibitor

Pembrolizumab for Gray Zone Lymphoma

Phase 2

Waitlist Available

Led By Mark J Roschewski, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 3-6 months, up to 2.5 years

Awards & highlights

Study Summary

This trial is studying the side effects of pembrolizumab and how well it works in treating people with rare, aggressive B-cell lymphomas.

Eligible Conditions

Gray Zone Lymphoma
Lymphoma
Non-Hodgkin's Lymphoma
Central Nervous System Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 3-6 months, up to 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 3-6 months, up to 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 3-6 months, up to 2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Best Overall Response Rate of Pembrolizumab in Participants With Relapsed/Refractory Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL)

Secondary outcome measures

Best Overall Response Rate According to the 5-point Lugano Classification for Interpreting 18 F-fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) Scans

Duration of Response for Participants Who Respond to Pembrolizumab

Event-free Survival (EFS)

+3 more

Other outcome measures

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with Gray-zone Lymphoma (GZL) or Extranodal Diffuse Large B-cell Lymphomas (DLBCL)Experimental Treatment1 Intervention

Participants with gray-zone lymphoma (GZL) or extranodal DLBCL relapsed from or refractory to prior therapy with an anthracycline-based regimen

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,662 Previous Clinical Trials

40,925,869 Total Patients Enrolled

1 Trials studying Gray Zone Lymphoma

348 Patients Enrolled for Gray Zone Lymphoma

Mark J Roschewski, M.D.Principal InvestigatorNational Cancer Institute (NCI)

18 Previous Clinical Trials

2,152 Total Patients Enrolled

1 Trials studying Gray Zone Lymphoma

348 Patients Enrolled for Gray Zone Lymphoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Pembrolizumab gained FDA approval as of yet?

"While there is some evidence to support the safety of Pembrolizumab, it did not receive a higher rating because Phase 2 trials have yet to produce data demonstrating efficacy."

Answered by AI

What are the standard indications for Pembrolizumab?

"Pembrolizumab is a medication used to treat malignant neoplasms, as well as other conditions such as unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."

Answered by AI

What is the existing research on Pembrolizumab?

"Pembrolizumab is being investigated in 1000 different clinical trials, 122 of which are currently ongoing. The majority of these studies are in their third phase of testing. While the largest number of trial sites for Pembrolizumab are located in Houston, Texas, there are a total of 36027 locations running studies for this treatment across the globe."

Answered by AI

Are there any current enrollees in this research project?

"No, this specific trial is not recruiting at the moment according to the latest information on clinicaltrials.gov. This particular study was first posted on February 15th, 2018 and last updated on November 4th, 2022. Although this research is no longer looking for volunteers, there are 2,861 other trials that are currently doing so."

Answered by AI

What is the total sample size for this research project?

"This particular clinical trial has finished recruiting patients. The listing was first posted on February 15th, 2018 and last updated on November 4th, 2022. There are 1861 other trials related to lymphoma and 1000 studies involving Pembrolizumab that are presently seeking participants."

Answered by AI

What are the specific aims of this research project?

"The primary objective of this 24-month study is to compare the best overall response rate of pembrolizumab in patients with relapsed/refractory gray- zone lymphomas (GZL) and extra-nodal diffuse large B-cell lymphomas (DLBCL). Additionally, researchers will secondary objectives including best overall response rate according to the 5-point Lugano classification for interpreting FOG-PET scans, overall survival (OS), and best overall response rate according to the 5-point Lugano classification for interpreting FDG-PET scans."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab in Relapsed and Refractory Gray-Zone Lymphoma (GZL), Primary Central Nervous System Lymphoma (PCNSL), and Other Extranodal Diffuse Large B-cell Lymphomas

Mark Roschewski, M.D. 2018. "Pembrolizumab in Relapsed and Refractory Gray-Zone Lymphoma (GZL), Primary Central Nervous System Lymphoma (PCNSL), and Other Extranodal Diffuse Large B-cell Lymphomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03255018.