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Pembrolizumab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

NCT03077828 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2023-06-02

Study results available
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Summary

The purpose of this research study is to evaluate a new drug Pembrolizumab in combination with chemotherapy, for Relapsed/Refractory Hodgkin Lymphoma. The chemotherapy regimen is called "ICE" and includes three drugs: ifosfamide, carboplatin, and etoposide. Pembrolizumab is currently Food and Drug Administration (FDA) approved for the treatment of some patients with melanoma, lung cancer and head and neck cancer, but has not yet been approved for the treatment of Relapsed/Refractory Hodgkin Lymphoma. The 'ICE' regimen of chemotherapy is currently FDA approved for the treatment of Relapsed/Refractory Hodgkin Lymphoma, but has not yet been investigated in combination with pembrolizumab for this disease. For patients who have a relapse of their Hodgkin's lymphoma, retreatment with chemotherapy followed by a stem cell transplant is recommended. We know that obtaining a complete remission (not able to detect any disease on scans) is very important prior to proceeding to the stem cell transplant. Patients with negative scans have a lower chance of the disease coming back and a higher chance of achieving a long-term cure.

Conditions

  • Lymphocyte-Rich Classical Hodgkin Lymphoma
  • Recurrent Lymphocyte-Depleted Classical Hodgkin Lymphoma
  • Recurrent Mixed Cellularity Classical Hodgkin Lymphoma
  • Recurrent Nodular Sclerosis Classical Hodgkin Lymphoma
  • Refractory Lymphocyte-Depleted Classical Hodgkin Lymphoma
  • Refractory Mixed Cellularity Classical Hodgkin Lymphoma
  • Refractory Nodular Sclerosis Classical Hodgkin Lymphoma

Interventions

DRUG

Carboplatin

Given IV

DRUG

Etoposide

Given IV

DRUG

Ifosfamide

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Pembrolizumab

Given IV

Sponsors & Collaborators

Principal Investigators

  • Jane N. Winter, M.D. · Northwestern University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-21
Primary Completion
2020-12-30
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03077828 on ClinicalTrials.gov