← Back to Search

Monoclonal Antibodies

Pembrolizumab for B-Cell Lymphoma

Phase 1 & 2
Waitlist Available
Led By Erel Joffe
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 up to 25 months
Awards & highlights

Study Summary

This trial is testing the combination of two immunotherapy drugs to treat patients with a specific type of lymphoma that has returned or does not respond to treatment.

Eligible Conditions
  • Diffuse Large B Cell Lymphoma (DLBCL)
  • Transformed B-Cell Non-Hodgkin Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 25 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 25 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events (Phase I)
Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D) of Mogamulizumab in Combination With Pembrolizumab (Phase I)
Progression-free Survival (PFS) (Phase II)
Secondary outcome measures
Complete Response Rate
Duration of Response
Overall Response Rate
+1 more
Other outcome measures
Biomarker Analysis

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (pembrolizumab)Experimental Treatment1 Intervention
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (pembrolizumab, mogamulizumab)Experimental Treatment2 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1 and mogamulizumab IV over 60 minutes on days 1, 8, and 15 of cycle 1, then day 1 of subsequent courses. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Mogamulizumab
2016
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,659 Total Patients Enrolled
Erel JoffePrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO

Media Library

Mogamulizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03309878 — Phase 1 & 2
B-Cell Lymphoma Research Study Groups: Arm I (pembrolizumab, mogamulizumab), Arm II (pembrolizumab)
B-Cell Lymphoma Clinical Trial 2023: Mogamulizumab Highlights & Side Effects. Trial Name: NCT03309878 — Phase 1 & 2
Mogamulizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03309878 — Phase 1 & 2

Frequently Asked Questions

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

Is enrollment currently open for this research endeavor?

"As indicated on clinicaltrials.gov, enrollment for this study has been closed as of September 15th 2022 after initially being posted to the website on June 29th 2018. However, there are over three-thousand six hundred and fifty seven other trials actively accepting patients at present."

Answered by AI

What pathologies can Mogamulizumab be employed to treat?

"Mogamulizumab can be used to deal with malignant tumours, inoperable melanoma, and cases of high microsatellite instability."

Answered by AI

How many participants are involved in this medical trial?

"This research is currently not recruiting. It was initially uploaded on June 29th, 2018 and last modified on September 15th 2022. If you are seeking alternative studies, a search reveals that there are 2,687 trials for lymphoma (large b-cell diffuse) actively recruiting and 970 clinical trials for Mogamulizumab accepting patients."

Answered by AI

Has Mogamulizumab been studied in any other research initiatives?

"Mogamulizumab initiated its clinical journey in 2010 at City of Hope. Thus far, 267 trials have yielded results and 970 are active with a considerable amount occurring in Montvale, New york."

Answered by AI

How many settings are participants able to access this experiment?

"8 clinical centres are presently recruiting patients to participate in this study. Among them, Memorial Sloan Kettering Bergen in Montvale, Memorial Sloan Kettering Monmouth in Middletown and the renowned Memorial Sloan Kettering Cancer Center located within New york City can be found alongside 5 other sites."

Answered by AI

What is the aim of this research project?

"This clinical trial will span a maximum of 6 weeks and seek to identify mogamulizumab's Maximum Tolerated Dose or Recommended Phase 2 Dosage when combined with pembrolizumab. Secondary objectives include calculating Complete Response Rate, Partial Response Rate, and Duration of Response using 95% confidence intervals and the Kaplan-Meier method respectively."

Answered by AI
~1 spots leftby Apr 2025