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New treatment option for Peripheral T Cells Lymphoma (PTCL)
Official title A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
ClinicalTrials.gov ID: NCT07018752
What this study is testing
What is roginolisib?
roginolisib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for peripheral t cells lymphoma (ptcl).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a platform trial for the evaluation of new drugs or combination of drugs in relapsed or refractory peripheral T-cell lymphomas. The objective of the study is to generate exploratory data on new drugs or combination of drugs to treat refractory/relapse peripheral T-cells lymphoma to better identify the population of interest and design future correct clinical trials.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures being conducted;
- Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF);
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements;
- Subject with histologically proven peripheral T-cell lymphoma according to the criteria of the WHO classification 2017 or 2022 (people with mycosis...
- Subject in relapse/refractory situation;
You likely can't join if
- Evidence of central nervous system involvement by lymphoma;
- Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study...
- Uncontrolled systemic fungal, bacterial, or viral infection;
- Known Hepatitis C Virus (HCV) or active Hepatitis B Virus (HBV) infection defined as subject with detectable viral load (respectively detectable...
- Active malignancy other than the one treated in this research, unless the subject has been free of the disease for 2 years (people with a history of...
- Use of any standard or experimental anti-cancer drug therapy within 28 days or a minimum of 5 half-lives of the drug, whatever the shortest prior to...
See the full eligibility criteria
Who can join
- Subject who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures being conducted;
- Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF);
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements;
- Subject with histologically proven peripheral T-cell lymphoma according to the criteria of the WHO classification 2017 or 2022 (people with mycosis fungoides, Sezary syndrome, lymphoblastic or large granular lymphocytic...
- Subject in relapse/refractory situation;
- ECOG performance status 0 to 2, or 3 if thought to be related to lymphoma;
- Adequate bone marrow function as defined by:
- Absolute Neutrophil Count ≥ 1,5 x 10\^9/L (≥ 1 x 10\^9/L if related to lymphoma)
- Platelets ≥ 75 x 10\^9/L (≥ 50 x 10\^9/L if related to lymphoma)
- Hemoglobin ≥ 8 g/dL;
- Anticipated life expectancy at least 3 months;
- Presence of disease specific criteria allowing response evaluation. Unless otherwise specified, such criteria include:
- Baseline fluorodeoxyglucose PET-scan demonstrating at least one positive (FDG-avid) lesion;
- and at least one bi-dimensionally measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extra nodal lesion, defined as \> 1.0 cm in its longest dimension;
- Contraception:
- For women of childbearing potential (WOCBP): must have a negative result for pregnancy test, at screening and within 24 hours prior to initiating study treatment. The WOCBP agree to abstain from becoming pregnant or...
- For men of reproductive potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use at least a condom as method of contraception with a non-pregnant female partner of childbearing potential...
- Subject covered by a social security system;
- Subject who understands and speaks one of the country official languages unless local regulation authorizes independent translators; Additional specific to Origina-ly-T sub-study:
- For anaplastic large cell lymphoma people: failed or ineligible or intolerant to brentuximab vedotin. For extranodal NK/T-cells lymphoma: failed or ineligible or intolerant to asparaginase-containing regimen; Additional...
- angioimmunoblastic type (AITL)
- follicular T cell type
- not otherwise specified (NOS); 14\. ECOG performance status 0 to 1 (supersedes criterium 6 of the Master protocol); 15\. people must have an international normalized ratio (INR) \ 3months prior to enrollment are...
- For women of childbearing potential (WOCBP): must have a negative result for pregnancy test, 10 to 14 days prior to initiating study treatment and within 24 hours prior to initiating study treatment. WOCBP agree to...
- For men: during the treatment period (including periods of treatment interruption), and for at least 28 days after the last dose of golcadomide and 3 months after the last dose of oral 5-azacitidine male people must:
- With female partners of childbearing potential: use a condom associated with a highly effective method of contraception or remain abstinent (refrain from heterosexual intercourse)
- With pregnant female partners: use a condom or remain abstinent (refrain from heterosexual intercourse) Men must refrain from donating sperm during this same period;
What rules you out
- Evidence of central nervous system involvement by lymphoma;
- Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator's decision);
- Uncontrolled systemic fungal, bacterial, or viral infection;
- Known Hepatitis C Virus (HCV) or active Hepatitis B Virus (HBV) infection defined as subject with detectable viral load (respectively detectable viral RNA or detectable viral DNA);
- Active malignancy other than the one treated in this research, unless the subject has been free of the disease for 2 years (people with a history of a completely resected non-melanoma skin cancer or successfully treated...
- Use of any standard or experimental anti-cancer drug therapy within 28 days or a minimum of 5 half-lives of the drug, whatever the shortest prior to first administration of study drug;.
- Subject taking corticosteroids within 14 days prior to first administration of study drug, unless administered at a cumulated dose equivalent of prednisone ≤ 20mg /day (within these 14 days);
- Subject with prior autologous hematopoietic cell transplantation (auto-HCT) ≤ 3 months prior to starting investigational product(s). If subject had autologous SCT (Stem Cell Transplant) \> 3 months prior to the start of...
- Subject with prior allogeneic hematopoietic cell transplantation (allo-HCT) with either standard or reduced intensity conditioning ≤ 3 months prior to starting investigational product(s). If subject had allogeneic SCT...
- Subject with major surgery ≤ 14 days prior to starting investigational product(s). people must have recovered from any clinically significant effects of recent surgery;
- Subject who has received prior localized anticancer therapy (eg. radiotherapy [including palliative radiotherapy]) ≤ 14 days prior to starting investigational product(s);
- Known or suspected hypersensitivity to active substance or to any of the excipients;
- Pregnant, planning to become pregnant, or lactating woman;
- Person deprived of his/her liberty by a judicial or administrative decision; Exclusion criteria specific to Origina-ly-T sub-study:
- Positive HIV test at screening, with the following exception: individuals with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy for at least 4 weeks, have a CD4 count ≥...
- Impaired renal function (calculated CKP-EPI, MDRD or Cockcroft-Gault Creatinine Clearance \ 34 μmol/L), except in case of Gilbert's Syndrome, or documented liver or pancreatic involvement by lymphoma, serum...
- Significant cardiovascular disease [e.g., Objective Class C or D heart diseases (cf. Classes of Heart Failure \| American Heart Association)], myocardial infarction within the previous 6 months, unstable arrhythmia, or...
- Prior exposure to PI3Kdelta inhibitor;
- Known or suspected allergies, hypersensitivity, or intolerance to Roginolisib or its excipients;
- Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications;
- people with a diagnosis of cutaneous T-cell lymphoma (CTCL);
- Prior solid organ transplantation; Exclusion criteria specific to GolcAza sub-study: 15\. Evidence of positive HTLV1 serology; 16\. Positive HIV test at screening, with the following exception: individuals with a...
The study team makes the final eligibility decision.
Where it's taking place
- Caen, France
- Clermont-Ferrand, France
- Créteil, France
- Dijon, France
- La Tronche, France
- Le Mans, France
- Lille, France
- Marseille, France
- Montpellier, France
- Nantes, France
- Paris, France
- Pessac, France
- Pierre-Bénite, France
- Poitiers, France
- Rennes, France
- Rouen, France
- Saint-Etienne, France
- Saint-Jean-de-Luz, France
- Strasbourg, France
- Vandœuvre-lès-Nancy, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Caen, France; Clermont-Ferrand, France; Créteil, France; Dijon, France; La Tronche, France; Le Mans, France and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.