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Pembrolizumab for Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
City of Hope Medical Center, Duarte, CARefractory Peripheral T-Cell Lymphoma, Not Otherwise Specified+19 MorePembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying pralatrexate and pembrolizumab to see how well they work in treating patients with peripheral T-cell lymphomas.

Eligible Conditions
  • Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
  • Large Cell Anaplastic Lymphoma
  • Nodal Peripheral T-Cell Lymphoma With Follicular Helper T-Cell Phenotype
  • Anaplastic Large Cell Lymphoma
  • Angioimmunoblastic T-cell Lymphoma
  • Recurrent Enteropathy-Associated T-Cell Lymphoma
  • Recurrent Follicular Lymphoma
  • Recurrent Hepatosplenic T-Cell Lymphoma
  • Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
  • Recurrent Monomorphic Epitheliotropic Intestinal T-cell Lymphoma
  • Mycosis Fungoides
  • Recurrent Peripheral T-Cell Lymphoma, Not Otherwise Specified
  • Refractory Enteropathy-Associated T-Cell Lymphoma
  • Refractory Follicular Lymphoma
  • Refractory Hepatosplenic T-Cell Lymphoma
  • Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
  • Subcutaneous Panniculitis-Like T Cell Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Dose Escalation
1
Pembrolizumab
1
Parsaclisib

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Up to 48 months

Month 48
Overall survival (OS)
Month 48
Progression-free survival (PFS)
Up to 21 days
Maximum tolerated dose defined as the highest doe level at which < 2 out of 6 evaluable subjects experienced dose limiting toxicities (Phase I)
Up to 48 months
CR rate according to the International Harmonization Project response criteria
Complete response (CR) rate according to Lugano classification
Duration of response (DOR) based on Lymphoma Response to Immunomodulatory therapy Criteria (LYRIC) criteria
ORR according to the International Harmonization Project response criteria
Overall response rate (ORR) according to Lugano classification (Phase II)
Day 90
Incidence of adverse events assessed by NCI CTCAE version (v)5.0
Incidence of unacceptable toxicity assessed by NCI CTCAE version 5.0

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Dose Escalation
1
Pembrolizumab
1
Parsaclisib

Side Effects for

Pembrolizumab Second Course
100%Inappropriate antidiuretic hormone secretion
100%Parkinsonism
100%Urinary tract infection
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Inappropriate antidiuretic hormone secretion with 100%, Parkinsonism with 100%, Urinary tract infection with 100%.

Trial Design

1 Treatment Group

Treatment (pralatrexate and pembrolizumab)
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 1 & 2

Treatment (pralatrexate and pembrolizumab)Experimental Group · 2 Interventions: Pembrolizumab, Pralatrexate · Intervention Types: Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Pralatrexate
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 48 months

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
524 Previous Clinical Trials
2,249,938 Total Patients Enrolled
1 Trials studying Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
62 Patients Enrolled for Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
National Cancer Institute (NCI)NIH
13,152 Previous Clinical Trials
41,162,959 Total Patients Enrolled
6 Trials studying Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
295 Patients Enrolled for Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
Alex F HerreraPrincipal InvestigatorCity of Hope Medical Center
11 Previous Clinical Trials
1,652 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a type of lymphoma called anaplastic large cell lymphoma that is ALK-positive.
You have a type of lymphoma called follicular T-cell lymphoma.
You have a specific type of lymphoma called extranodal NK-/T-cell lymphoma.
You have a type of T-cell lymphoma called angioimmunoblastic T-cell lymphoma.
You have a certain type of lymphoma called nodal peripheral T-cell lymphoma with TFH phenotype.
You have a slow-growing type of cancer that affects the digestive system called indolent T-cell lymphoproliferative disorder.
You must be able to sign a paper that explains the study and says you agree to participate. If you are not able to sign it, your legal representative can sign it for you.
You are in good enough physical condition to be able to carry out daily activities without help.
You have a type of non-Hodgkin's lymphoma called peripheral T-cell lymphoma, which is not a specific subtype.
You have a type of lymphoma called anaplastic large cell lymphoma, but you do not have a specific gene mutation (ALK-negative).
References

Frequently Asked Questions

How many people are currently participating in this research?

"To carry out this research, we need 40 individuals that fit the pre-determined inclusion criteria. Those who take part in this experiment can do so from various hospitals, like Emory University Hospital/Winship Cancer Institute in Atlanta or University of Nebraska Medical Center located in Omaha." - Anonymous Online Contributor

Unverified Answer

Can patients still sign up for this research study?

"Correct, the clinicaltrial.gov website has information stating that this trial is looking for patients right now. The original posting date was February 4th, 2019 and the most recent update was on August 15th, 2022. They are recruiting 40 people to participate at 3 different locations." - Anonymous Online Contributor

Unverified Answer

For what purpose is Pembrolizumab most often prescribed?

"Pembrolizumab is a medication that can be used to treat various conditions, such as unresectable melanoma or microsatellite instability high. It is most commonly taken to fight malignant neoplasms though." - Anonymous Online Contributor

Unverified Answer

What are some other experimental treatments that have used Pembrolizumab?

"Pembrolizumab was first studied a decade ago, in 2010, at City of Hope. 272 studies have reached completion and there are 1002 more underway; many of these are based in Atlanta, Georgia." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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