Pembrolizumab for Waldenstrom Macroglobulinemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Waldenstrom Macroglobulinemia+31 More
Pembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing pembrolizumab alone or with idelalisib or ibrutinib as a treatment for relapsed or refractory chronic lymphocytic leukemia or other low-grade B-cell non-Hodgkin lymphomas.

Eligible Conditions
  • Waldenstrom Macroglobulinemia
  • B-Lymphocytes
  • Refractory Follicular Lymphoma
  • Chronic Lymphocytic Leukemia
  • Recurrent Splenic Marginal Zone Lymphoma
  • Refractory Lymphoplasmacytic Lymphoma
  • Lymphoma
  • Richter's Syndrome
  • chronic, recurrent Lymphocytic Leukemia
  • Lymphoid Tissue
  • Lymphoma, Follicular
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Lymphoplasmacytic Lymphoma
  • Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
  • Refractory Small Lymphocytic Lymphoma
  • Waldenstrom's Macroglobulinemia Refractory

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Waldenstrom Macroglobulinemia

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Up to 1 year

Year 1
Change in immune profiles
Change in markers of immune modulation
Year 1
Duration of response
Year 1
Time to next treatment for patients on combination therapy
Year 1
Progression-free survival of patients treated with combination therapy
Year 1
Overall survival
Year 1
Treatment-free survival of patients treated with single-agent pembrolizumab
Year 1
Time to next treatment for patients treated with single-agent pembrolizumab
Year 1
Progression-free survival of patients treated with single pembrolizumab
Year 1
Treatment-free survival of patients treated with combination therapy
Up to 1 year
Complete response rate
Incidence of adverse events
Overall response rate of patients treated with combination therapy
PD-1 levels
PD-L1 levels
PD-L2 levels
Proportion of patients who achieve a confirmed response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Waldenstrom Macroglobulinemia

Side Effects for

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

Trial Design

1 Treatment Group

Treatment (pembrolizumab, idelalisib, or ibrutinib)
1 of 1
Experimental Treatment

65 Total Participants · 1 Treatment Group

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Treatment (pembrolizumab, idelalisib, or ibrutinib)Experimental Group · 4 Interventions: Ibrutinib, Laboratory Biomarker Analysis, Idelalisib, Pembrolizumab · Intervention Types: Drug, Other, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
FDA approved
Idelalisib
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,990 Previous Clinical Trials
41,298,823 Total Patients Enrolled
136 Trials studying Waldenstrom Macroglobulinemia
9,774 Patients Enrolled for Waldenstrom Macroglobulinemia
Mayo ClinicLead Sponsor
2,892 Previous Clinical Trials
3,698,672 Total Patients Enrolled
10 Trials studying Waldenstrom Macroglobulinemia
374 Patients Enrolled for Waldenstrom Macroglobulinemia
Wei DingPrincipal InvestigatorMayo Clinic in Rochester
2 Previous Clinical Trials
48 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 kappa or lambda light chain expression or other genetic method evidence of clonality.
You have lymphadenopathy, splenomegaly, or hepatomegaly.
Prior oral corticosteroid therapy for an indication other than CLL will not be considered prior treatment.
Patients must be previously treated with at least one prior line of therapy
You have previously used corticosteroids in combination with other therapy for treatment of autoimmune complications of CLL.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: October 10th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.