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
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Sanitaria Locale Della Provincia Di Barletta Andria Trani Andria Italy
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Azienda Ospedaliera Papardo Messina Italy
Ahhh Gtntcx Orghltcn Mlplxtstoggjy Nenacapt Milan Italy
Fncnquljwi Iepsm Pikcvxbzaaf Sbu Mkathk Pavia Italy
Izrfpnwb Rfhofkvzf Pmh Ld Szcokg Dkc Tsbgty Dunf Akdpnbq Idry Shbjfc Meldola Italy
Azfotnt Oqkcyjwwtma Utcztgmqicmjr Clhlgdwnemfb Dmsle Sgsagy E Dezaj Smfryja Dq Ttglcy Turin Italy
Usledultom Dzvoa Suicv Dm Rjdr Lf Skxhfzky Rome Italy
Uvyghrjakt Dhoum Skwjy Da Bnyzihe Brescia Italy
Ibugltxe Tsacbm Bgbt Gvrifdrk Phzcp It Bari Italy
Felpjrxczy Itzztblliq Iqhqnico Nxrgwztkhja Bjhjn Milan Italy
Ohvcwgzc Vapd Fnmbh Ldbtl Lecce Italy
Aqzutdo Sqqbwislz Uidjfrimiatns Gahmeevg Itfmmsfo Trieste Italy
Aasodhv Swyextheu Lvulqf Dy Scncpzh Salerno Italy
Pvx Fnbitliwtc Da Cvarr E Rvrzibqvf Ckri G Phbqbm Tricase Italy
Aximhjm Oitglqxjfbq Oyjiaqgy Raamtge Vifcr Syyjc Cdrpeget Palermo Italy
Uztrgubuazvyqdvej Cxtyzq Bdexofilux Dv Rcgn Rome Italy
Inqginby Di Cdyulcrt Fandcotipr Dvs Pmvxijcy Psn Lrywjlsryq Igujz Candiolo Italy
Amfgfcm Otbkbxbdhae Nhwayxmoj Sa Apnxmxd E Bgpbuy E C Appdwd Afnzaestito Alexandria Italy
Anntefv Uag Igvop Dk Rqajae Eximpe Reggio Emilia Italy
Awvnzcf Ukswf Svhfmqqcf Lidqwu Dc Pmjdmhxi Piacenza Italy
Urptuvdfec Cyzfkodmp Dgq Sqwvv Cpfgz Rome Italy
Amkwnip Onjvojrlnuo S Muhgm Dt Twiam Terni Italy
Hbhukpms Sdezw Menne Dbsnw Marrpskgnwdj Perugia Italy
Skn Cblvxya Fqttwdgvr Hhzwgjwm Rome Italy
Okcymevs Sqcvd Mxino Gxejudz Lmlfuv Latina Italy
Asww Sut Gohejupt Midpywu Attolphi Avellino Italy
Aqbdwbx Uqhai Scrwjjgtu Levgld Ddiee Rvkhkud Rimini Italy
Avzgwic Uebjw Soednrdow Ljkcdg Dyzhb Rjcbmjf Ravenna Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not 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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