Study of Atezolizumab and Drug Combination for Patients with Relapsed or Refractory Hodgkin’s Lymphoma Eligible for Stem Cell Transplant

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What is this study about?

This clinical trial is focused on studying a type of cancer called Hodgkin’s lymphoma, which affects the lymphatic system, a part of the immune system. The study is testing a combination of treatments to see how effective they are for patients whose disease has returned or did not respond to initial treatments. The treatments being studied include atezolizumab, a type of medication known as a monoclonal antibody, and a combination of drugs known as the BEGEV regimen. The BEGEV regimen includes the drugs bendamustine hydrochloride, gemcitabine, vinorelbine, and vinorelbine tartrate. These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to find the best dose of atezolizumab when used with the BEGEV regimen and to see how well this combination works before patients undergo a procedure called autologous stem-cell transplantation. This procedure involves using a patient’s own stem cells to help restore their bone marrow after intensive treatment. The study is divided into two phases. In the first phase, researchers will determine the safest and most effective dose of atezolizumab. In the second phase, they will assess how well the treatment works in reducing the cancer before the stem-cell transplantation.

Participants in the study will receive the treatment over several cycles, with regular assessments to monitor their response to the therapy. The study aims to provide valuable information on the effectiveness and safety of this treatment combination for patients with relapsed or refractory Hodgkin’s lymphoma. The results will help guide future treatment options for this condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, previous treatments, and health status.

The study is designed for patients with relapsed or refractory Hodgkin’s lymphoma who are candidates for stem-cell transplantation.

2 phase I treatment

The initial phase aims to determine the maximum tolerated dose of atezolizumab in combination with the BEGEV regimen.

The BEGEV regimen includes bendamustine hydrochloride, vinorelbine, and gemcitabine, all administered through intravenous infusion.

This phase involves monitoring for any severe side effects during the first 21 days of treatment.

3 phase IIb treatment

In this phase, the effectiveness of the treatment is assessed after four cycles of the induction treatment.

The response to treatment is evaluated using specific criteria to determine the complete response rate before stem-cell transplantation.

4 monitoring and assessment

Throughout the study, regular assessments are conducted to monitor the patient’s response to treatment and any adverse effects.

These assessments include imaging tests and blood tests to evaluate the disease status and overall health.

5 completion of treatment

Upon completion of the treatment cycles, the patient’s response is thoroughly evaluated.

The study aims to determine the duration of response and progression-free survival, which measures the time until the disease progresses or relapses.

Who Can Join the Study?

  • Must be between 18 and 60 years old (the upper age limit is only for phase I).
  • Must have a confirmed diagnosis of Hodgkin’s lymphoma. This means the disease has either come back after treatment or did not respond to the first treatment. The first treatment could have been one of several specific drug combinations.
  • Must have had only one previous treatment for Hodgkin’s lymphoma.
  • Must be eligible for ASCT, which stands for autologous stem cell transplant, a procedure that uses the patient’s own stem cells.
  • Must have a performance status of 2 or less on the ECOG scale. This scale measures how well a person can perform daily activities, with lower numbers indicating better ability.
  • Must have adequate blood function, unless the lymphoma affects the bone marrow. This means having enough neutrophils (a type of white blood cell), platelets (cells that help with blood clotting), and hemoglobin (a protein in red blood cells) without needing blood transfusions.
  • Must be able and willing to follow the study visit schedule and procedures.
  • Must agree to use effective birth control without interruption, starting 28 days before treatment and continuing for at least 6 months after treatment ends. Participants must also agree not to donate semen or eggs during treatment and for at least 6 months after the last treatment dose.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than Hodgkin’s lymphoma.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who have any medical condition that the study doctors think might make it unsafe for them to participate.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent major surgery or are recovering from one.
  • Patients who have a history of severe allergic reactions to any of the study medications.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an active infection that requires treatment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy

Other Sites

Site Name City Country Status
Ospedale Vito Fazzi Lecce Lecce Italy
Azienda Sanitaria Universitaria Giuliano Isontina Trieste Italy
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Unita Sanitaria Locale Di Piacenza Piacenza Italy
Universita Cattolica Del Sacro Cuore Rome Italy
Azienda Ospedaliera S Maria Di Terni Terni Italy
Hospital Santa Maria Della Misericordia Perugia Italy
San Camillo Forlanini Hospital Rome Italy
Istituto Tumori Bari Giovanni Paolo II Bari Italy
AORN San Giuseppe Moscati Avellino Avellino Italy
Ospedale Santa Maria Goretti Latina Latina Italy
Azienda Ospedaliera Papardo Messina Italy
Pia Fondazione Di Culto E Religione Card G Panico Tricase Italy
Azienda Sanitaria Locale Della Provincia Di Barletta Andria Trani Andria Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Universita Degli Studi Di Brescia Brescia Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
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Amtpxpp Owbarvrcbax Ortfpryh Rqfahvb Vzawv Szspv Cmhkqceq Palermo Italy
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Azckseb Ontlihzzkqj Nwakvhkix Sh Aitrnkv E Bzugmb E C Adiequ Ackscchgwec Alexandria Italy
Aryvahf Uun Ieqgy Dd Radamc Eqvexg Reggio Emilia Italy
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
27.02.2023

Trial locations

Atezolizumab is a medication used in this trial to help the immune system attack cancer cells. It is a type of immunotherapy that works by blocking a protein that prevents the immune system from effectively fighting cancer. In this study, it is combined with other treatments to see if it can improve outcomes for patients with Hodgkin’s lymphoma.

BEGEV regimen is a combination of chemotherapy drugs used to treat Hodgkin’s lymphoma. This regimen includes several medications that work together to kill cancer cells or stop them from growing. The BEGEV regimen is used as a first salvage treatment, which means it is given to patients whose cancer has returned or not responded to previous treatments.

Hodgkin’s Lymphoma – Hodgkin’s lymphoma 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 Reed-Sternberg cells, a specific type of abnormal cell. The disease typically begins in the lymph nodes and can spread to other parts of the body, including the spleen, liver, and bone marrow. Symptoms often include painless swelling of lymph nodes, fever, night sweats, and weight loss. As the disease progresses, it may affect the body’s ability to fight infections. Hodgkin’s lymphoma is generally considered a rare disease but is one of the most treatable forms of cancer.

Trial ID:
2024-511631-10-00
NCT ID:
NCT05300282
Trial Phase:
Human Pharmacology (Phase I) – Other

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