MedTrace Logo

A Trial Comparing Chemotherapy Versus Novel Immune Checkpoint Inhibitor (Pembrolizumab) Plus Chemotherapy in Treating Relapsed/Refractory Classical Hodgkin Lymphoma

NCT05711628 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-03-20

No results posted yet for this study

Summary

This phase III trial compares chemotherapy versus an immune checkpoint inhibitor drug called pembrolizumab plus chemotherapy in treating patients with classical Hodgkin lymphoma that has come back (relapsed) or that does not respond to treatment (refractory). The usual approach for patients with classical Hodgkin lymphoma is treatment with standard chemotherapy, including drugs that are Food and Drug Administration (FDA)-approved. If this treatment puts a patient into remission, high dose chemotherapy and stem cell transplant may be used to increase the likelihood of a cure. Hodgkin lymphoma is capable of inhibiting the immune system from killing it. Pembrolizumab is a checkpoint inhibitor that may be able to stop this inhibition, allowing the immune system to attack the lymphoma.

Conditions

  • Recurrent Classic Hodgkin Lymphoma
  • Refractory Classic Hodgkin Lymphoma

Interventions

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo ASCT

DRUG

Bendamustine

Given IV

DRUG

Brentuximab Vedotin

Given IV

DRUG

Carboplatin

Given IV

PROCEDURE

Computed Tomography

Undergo PET/CT and CT

DRUG

Etoposide

Given IV

DRUG

Gemcitabine

Given IV

DRUG

Ifosfamide

Given IV

DRUG

Pegylated Liposomal Doxorubicin Hydrochloride

Given IV

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

RADIATION

Radiation Therapy

Undergo RT

OTHER

Transplant Conditioning

Receive standard preparative chemotherapy regimen

DRUG

Vinorelbine

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Vaishalee P Kenkre · ECOG-ACRIN Cancer Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-10
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Drug
Yes

More Related Trials

Entities

Drugs

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 NCT05711628 on ClinicalTrials.gov