Study of Ruxolitinib with Brentuximab or Pembrolizumab for Patients with Relapsed or Refractory Classical Hodgkin Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called classical Hodgkin lymphoma (cHL), which is a cancer of the lymphatic system. The study is specifically for patients whose cHL has returned or did not respond to previous treatments. The trial is testing the effectiveness of combining a medication called ruxolitinib with either brentuximab vedotin or pembrolizumab. Ruxolitinib is a drug that helps to block certain proteins that can cause cancer cells to grow. Brentuximab vedotin is a type of medication known as an antibody-drug conjugate, which targets cancer cells, and pembrolizumab is an immunotherapy drug that helps the immune system fight cancer.

The purpose of the study is to see how well these drug combinations work in treating patients with relapsed or refractory cHL. The study is divided into two groups, or cohorts. In one group, patients will receive ruxolitinib with brentuximab vedotin, and in the other group, patients will receive ruxolitinib with pembrolizumab. The study will monitor the patients’ response to these treatments over a period of time, looking for signs of complete response, which means the cancer has disappeared, or partial response, where the cancer has shrunk but not completely gone away.

Throughout the study, researchers will also keep track of any side effects that occur and how they relate to the study drugs. The study aims to improve the rate of complete response compared to past treatments. Additionally, the study will explore the possibility of using these treatments to prepare patients for stem cell transplants, which can be a part of cancer treatment. The trial will also look for potential markers in the body that might predict how well a patient will respond to the treatment. The study is expected to continue until 2026.

1 enrollment

Upon joining the study, eligibility is confirmed based on specific criteria. This includes having relapsed or refractory classical Hodgkin lymphoma (cHL) and meeting other health and treatment history requirements.

Informed consent is signed before any study-related procedures begin.

2 initial assessment

A comprehensive health assessment is conducted. This includes a review of medical history, a physical examination, and necessary laboratory tests.

A baseline whole-blood sample of 40 ml is collected for analysis.

3 treatment assignment

Participants are assigned to one of two treatment groups, known as cohorts, based on their medical history and specific criteria.

Cohort-1 receives a combination of ruxolitinib and brentuximab vedotin. Cohort-2 receives a combination of ruxolitinib and pembrolizumab.

4 treatment administration

For Cohort-1, ruxolitinib is administered orally, and brentuximab vedotin is given through an intravenous infusion.

For Cohort-2, ruxolitinib is administered orally, and pembrolizumab is given through an intravenous infusion.

The treatment continues as per the study protocol, with regular monitoring and assessments.

5 interim evaluation

An interim evaluation is conducted to assess the response to the treatment. This includes imaging studies and laboratory tests to measure the disease status.

The primary goal is to determine the rate of complete response (CR) during or at the end of ruxolitinib treatment.

6 continuation or adjustment

Based on the interim evaluation, the treatment may continue as planned, or adjustments may be made if necessary.

Participants are monitored for any adverse events and their relationship to the study drugs.

7 final evaluation

A final evaluation is conducted at the end of the treatment period to assess the overall response to the study drugs.

This includes determining the rates of complete response, partial response, and stable disease.

8 follow-up

Participants enter a follow-up phase where their health and disease status are monitored over time.

The follow-up includes assessments of survival rates and any subsequent treatments received.

Who Can Join the Study?

Patients must have relapsed or refractory classical Hodgkin lymphoma (cHL), which means the disease has returned or did not respond to previous treatments.
Patients must be 18 years or older.
For Cohort-1 (ruxolitinib + brentuximab):
- Patients must have CD30+ cHL that has relapsed or is refractory after an autologous stem cell transplantation (ASCT), or after at least two previous treatments if ASCT or other chemotherapy options are not suitable.
- Patients cannot have received an allotransplant (a transplant from a donor) previously.
- Patients must be able to receive at least 8 infusions of brentuximab.
- Patients who progressed on brentuximab before registering with the AIFA registry can be enrolled.
- Patients from Cohort-2 who had important side effects from pembrolizumab and did not respond to treatment may be considered for Cohort-1.
For Cohort-2 (ruxolitinib + pembrolizumab):
- Patients must have relapsed or refractory cHL previously treated with both ASCT or at least two prior therapies when ASCT is not an option.
- Patients can have received an allotransplant, but not a PD1 or PDL1 inhibitor (types of cancer treatments).
- Patients from Cohort-1 who had important side effects from brentuximab and did not respond to treatment may be considered for Cohort-2.
Patients must have a confirmed diagnosis of classical Hodgkin lymphoma through specific tests.
Patients must have at least one measurable tumor on a PET-CT scan.
Patients must provide a tumor biopsy sample for testing.
Patients must provide a blood sample for testing.
Patients must have an ECOG performance status of 0-1 for Cohort-1 or 0-2 for Cohort-2. This is a scale that measures how well patients can perform daily activities.
Patients must have a life expectancy of at least 5 months.
Any previous cancer treatment must have been completed at least 4 weeks before starting the study medication, unless the disease has clearly progressed earlier.
Patients must sign an informed consent form before any study-related procedures.

Who Cannot Join the Study?

Patients who have a type of cancer called cHL (classical Hodgkin Lymphoma) that has come back or not responded to treatment cannot join if they only had a partial response to their last treatment.
Patients who have not shown any improvement or whose condition has worsened after their last treatment are not eligible.
Patients who have had a partial response to their last treatment, including special treatments like salvage therapy (a treatment given after the cancer has not responded to other treatments) before a transplant (a procedure to replace damaged cells with healthy ones), cannot join unless their condition worsens later.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Hospital Santa Maria Della Misericordia	Perugia	Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli	Reggio Calabria	Italy
Azienda Ospedaliera di Padova	Padua	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Aupbcqb Opwredvxtri Oepdzqgm Rajpbjk Vkgwm Scxnk Chkkhpdx	Palermo	Italy
Akvzhkh Oupkqjvzhsl Uwxrtbgkurvfd Clbublrwzbvz Deccs Srtova E Dyapk Sxjxudv Df Tbyhnk	Turin	Italy
Uzblsoityl Dchqf Sklvq Da Rhda Lo Sxjcvktb	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.02.2020

Trial locations

Investigated drugs:

Ruxolitinib is a medication used in this trial to help treat patients with relapsed or refractory classical Hodgkin lymphoma. It works by inhibiting certain proteins (JAK1/2) that are involved in the growth and survival of cancer cells. The goal is to see if it can help reduce the cancer when used in combination with other treatments.

Brentuximab is an antibody-drug conjugate used in this trial to target and destroy cancer cells in patients with classical Hodgkin lymphoma. It binds to a specific protein on the surface of the cancer cells and delivers a toxic substance directly to them, which can help to kill the cancer cells.

Pembrolizumab is an immunotherapy drug used in this trial to help the body’s immune system fight cancer. It works by blocking a protein that prevents the immune system from attacking cancer cells, thereby allowing the immune system to better recognize and destroy these cells.

Classical Hodgkin Lymphoma (cHL) – This is a type of cancer that originates in the lymphatic system, which is part of the body’s immune system. It is characterized by the presence of large, abnormal cells known as Reed-Sternberg cells. The disease often begins in the lymph nodes and can spread to other parts of the body, including the spleen, liver, and bone marrow. Patients with relapsed or refractory cHL have a form of the disease that has not responded to initial treatments or has returned after treatment. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The progression of cHL can vary, with some cases advancing slowly while others may progress more rapidly.

Trial ID:

2024-520123-83-01

Protocol code:

cHL-PG01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Ruxolitinib with Brentuximab or Pembrolizumab for Patients with Relapsed or Refractory Classical Hodgkin Lymphoma

What is this study about?

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