Study Comparing Duvelisib with Gemcitabine or Bendamustine for Patients with Relapsed or Resistant T Cell Lymphoma Originating from T Follicular Helper Cells

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What is this study about?

This clinical trial is focused on studying a type of blood cancer known as nodal T cell lymphoma, which originates from a specific type of T cells called T follicular helper (TFH) cells. The study is specifically for patients whose cancer has returned after treatment, known as relapsed, or has not responded to previous treatments, known as refractory. The trial will compare the effectiveness of a medication called Duvelisib against two other anti-cancer drugs, Gemcitabine and Bendamustine.

The purpose of the study is to evaluate how well Duvelisib works in extending the time patients live without their disease getting worse, compared to the other two drugs. Participants in the study will be randomly assigned to receive either Duvelisib or the doctor’s choice of Gemcitabine or Bendamustine. Duvelisib is taken orally in the form of hard capsules, while Gemcitabine and Bendamustine are administered intravenously, meaning they are given through a vein. The study will monitor participants over a period of up to three years to assess the progression of the disease and overall survival, as well as the quality of life and any side effects experienced.

This trial aims to provide valuable information on the best treatment options for patients with this type of lymphoma. By comparing these treatments, the study hopes to find the most effective way to manage the disease and improve patient outcomes. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

1 joining the trial

Upon joining the trial, you will be randomly assigned to one of two groups. One group will receive the medication duvelisib, while the other group will receive either gemcitabine or bendamustine, as determined by the study team.

2 medication administration

If you are assigned to the duvelisib group, you will take Copiktra capsules orally. The dosage will be either 15 mg or 25 mg, as prescribed by the study team. You will take these capsules twice daily.

If you are assigned to the gemcitabine or bendamustine group, these medications will be administered intravenously, meaning they will be given through a vein. The specific dosage and frequency will be determined by the study team.

3 regular check-ups

Throughout the trial, you will have regular check-ups to monitor your health and the effects of the medication. These check-ups will include physical exams, blood tests, and other necessary assessments.

4 progress evaluation

Your progress will be evaluated regularly to determine how the treatment is affecting your condition. This will include assessments of your disease status and any side effects you may experience.

5 quality of life assessments

You will be asked to complete questionnaires about your quality of life. These assessments will help understand the impact of the treatment on your daily activities and overall well-being.

6 end of trial

The trial will continue for up to three years, or until the study team determines that it is appropriate to conclude your participation. At the end of the trial, you will have a final evaluation to assess your health and the outcomes of the treatment.

Who Can Join the Study?

  • Must have a diagnosis of nodal T cell lymphoma with TFH phenotype. This includes types like Angioimmunoblastic T cell lymphoma (AITL), follicular T cell lymphoma, and other nodal peripheral T cell lymphomas with a TFH phenotype.
  • The disease must have come back (relapsed) or not responded (refractory) to at least one previous treatment that involved systemic, cytotoxic therapy for T cell lymphoma.
  • Must have a measurable disease as defined by specific medical criteria (Lugano 2014 criteria).
  • Must have an ECOG Performance Status of 0, 1, or 2. This is a scale used to assess how a disease affects a patient’s daily living abilities, where 0 means fully active and 2 means capable of all self-care but unable to carry out any work activities.
  • Open to both male and female participants.
  • Includes participants from vulnerable populations.

Who Cannot Join the Study?

  • Patients who have not experienced a return or worsening of their nodal T cell lymphoma with T follicular helper (TFH) phenotype cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial groups cannot participate.
  • Patients who are not female or male cannot participate.
  • Patients who are not considered part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Hospital Universitario De Salamanca Salamanca Spain
Universitaet Leipzig Leipzig Germany
Katholieke Universiteit te Leuven Leuven Belgium
Universitaetsmedizin Goettingen Goettingen Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
University Hospital Maastricht Maastricht The Netherlands
Institut Curie – Site Paris Paris France

Other Sites

Site Name City Country Status
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Universitair Ziekenhuis Gent Gent Belgium
Instytut Hematologii I Transfuzjologii Warsaw Poland
Centre Henri Becquerel Rouen France
KLINIKEN ESSEN SUED Evangelisches Krankenhaus Essen-Werden gGmbH Essen Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Rennes Rennes France
Rigshospitalet Copenhagen Denmark
Virgen del Rocío University Hospital Sevilla Spain
Odense University Hospital Odense Denmark
Pratia S.A. Skorzewo Poland
Region Midtjylland Aarhus Denmark
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Lqxly Ucfuhepiziay Mzroshy Cdfsyld (euueh Leiden The Netherlands
Mofugwiqvqsrwqqnwqpusohctr Htitgvlmfovsonym Halle (Saale) Germany
Iarkozvd Calrts Dmsshdujnwshumrve L'hospitalet De Llobregat Spain
Asgwopnug Uxh Amsterdam The Netherlands
Avvwosa Oqumsgvbdfm Nszgqlxas Se Aixrspw E Bnomex E C Aoimru Apldxhtjuye Alexandria Italy
Ujgscdjwkuhvmi Cvimnwk Kzrrqwxnv Gdansk Poland
Aoqruho Ujacr Scohnzzqo Lwnrhr Dj Bqljaxf Bologna Italy
Atqgsxs Opznbksmbdv Pdfw Gdicgzkf Xoazi Bergamo Italy
Eimdthh Ulruabweabwb Mxgzuvv Cydwodi Ruaaqvvgt (xycadzx Mlj Rotterdam The Netherlands
Netpsikx Inxwismm Ohtekbcyr Ipn Mkjdf Sibsnvhlinbcglkflxbdqgfkmmgu Iqnbeipu Bpvieohg Cracow Poland
Ihuzjdey Pmxpvsjvgvbsjrh Coewvz Ceoymk Marseille France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.04.2025
Czechia Czechia
Recruiting
01.04.2025
Denmark Denmark
Recruiting
01.04.2025
France France
Recruiting
01.04.2025
Germany Germany
Recruiting
01.04.2025
Italy Italy
Recruiting
01.04.2025
Poland Poland
Recruiting
01.04.2025
Spain Spain
Recruiting
01.04.2025
The Netherlands The Netherlands
Recruiting
01.04.2025

Trial locations

Duvelisib is a medication used in this clinical trial to treat patients with a type of blood cancer called nodal T cell lymphoma. It works by blocking certain proteins in the body that help cancer cells grow and survive. By doing this, duvelisib can help slow down or stop the progression of the cancer.

Gemcitabine is another medication used in this trial. It is a type of chemotherapy that helps to kill cancer cells. Gemcitabine works by interfering with the DNA of the cancer cells, preventing them from multiplying and spreading. This can help reduce the size of the cancer and control its growth.

Bendamustine is also used in this study as a treatment option. It is a chemotherapy drug that attacks cancer cells by damaging their DNA, which stops them from dividing and growing. Bendamustine is used to help manage and reduce the symptoms of the cancer, aiming to improve the patient’s quality of life.

Relapsed/Refractory Nodal T Cell Lymphoma with T Follicular Helper (TFH) Phenotype – This is a type of non-Hodgkin lymphoma that originates from T cells, a kind of white blood cell. It specifically involves the T follicular helper cells, which are crucial for the immune system’s response. The disease is characterized by the recurrence or persistence of lymphoma after initial treatment. It typically presents with enlarged lymph nodes and can affect other organs. As the disease progresses, it may lead to symptoms such as fatigue, fever, and weight loss. The progression involves the continued growth and spread of cancerous cells in the lymphatic system.

Trial ID:
2024-516605-23-00
Protocol code:
SBI-0145-304
NCT ID:
NCT06522737
Trial Phase:
Therapeutic confirmatory (Phase III)

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