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New treatment option for Richter Syndrome
Official title Evaluation of Treatment by Glofitamab in Combination With Rituximab or Obinutuzumab Plus CHOP in Patients With RIchter Syndrome
ClinicalTrials.gov ID: NCT06186648
What this study is testing
What is Glofitamab + Obinutuzumab?
Glofitamab + Obinutuzumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for richter syndrome.
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 is a national clinical trial, multicentric (28 centers), non-randomized phase 2 study. Population: Patients with previously untreated Richter's syndrome (RS), defined as the occurrence of an aggressive lymphoma (of diffuse large B-cell lymphoma histology) in a patient with chronic lymphocytic leukemia (CLL).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma according to the revised iwCLL criteria with biopsy proven...
- A fresh or archival tissue biopsy is mandatory
- Previous therapy for CLL is allowed (but no prior therapy for RS)
- Age greater than or equal to 18 years and less or equal to 80 years
- ECOG performance status 0-2
You likely can't join if
- Patients with the Hodgkin variant of RS
- Patients with previously treated for RS
- Current or past history or presence of clinically relevant disorder affecting the central nervous system (CNS)
- Ineligible to CHOP full dose for any reason
- Previous treatment with a bispecific antibody
- Current or past history of DLBCL in the CNS (confirmed by CSF analysis)
See the full eligibility criteria
Who can join
- Confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma according to the revised iwCLL criteria with biopsy proven transformation to CD20 positive diffuse large B-cell lymphoma, consistent with...
- A fresh or archival tissue biopsy is mandatory
- Previous therapy for CLL is allowed (but no prior therapy for RS)
- Age greater than or equal to 18 years and less or equal to 80 years
- ECOG performance status 0-2
- Participants must have at least one measurable target lesion (≥ 1.5 cm) in its largest dimension by computed tomography (CT) scan. Measurable disease, defined as at least one bi-dimensionally measurable nodal or tumor...
- Patients must meet the following hematologic criteria at screening, unless they have significant bone marrow involvement of either CLL or RS cells confirmed on biopsy: absolute neutrophil count ≥ 1.5 G/L, hemoglobin...
- Subject must have adequate coagulation tests: Prothrombin Time \> 50%, Fibrinogen \> 1 g/L
- Adequate liver function: Total bilirubin ≤ 1.5 x ULN; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x ULN
- Adequate left ventricular ejection function (\> 50 %)
- Adequate renal function: creatinine clearance calculated by MDRD/Cockcroft-Gault formula of ≥ 40 mL/min
- Negative serologic or PCR test results for acute or chronic HBV infection
- Negative test results for HCV and HIV (Patients who are positive for HCV antibody must be negative for HCV by PCR to be eligible for study participation)
- Prior vaccination to the SARS-Cov-2 virus and and SARS-CoV-2 PCR testing and negative result before study treatment administration at each treatment cycle
- Negative serum or urinary pregnancy test within 7 days prior to study treatment in women of childbearing potential. Patients must agree to either remain completely abstinent or to use two effective contraceptive...
- If the patient is a male: at least 3 months after pre-treatment with obinutuzumab or RCHOP or 2 months after the last dose of glofitamab, whichever is longer. Men must refrain from donating sperm during this same period
- If patient is a female of childbearing potential: until at least 18 months after pre-treatment with obinutuzumab or RCHOP or 2 months after the last dose of glofitamab, whichever is longer
- Ability to understand and the willingness to sign a written informed consent document. Patient must be willing and able to comply with protocol-mandated hospitalization upon administration of the first dose of...
- Signed written informed consent
- Patient covered by any social security system
What rules you out
- Patients with the Hodgkin variant of RS
- Patients with previously treated for RS
- Current or past history or presence of clinically relevant disorder affecting the central nervous system (CNS)
- Ineligible to CHOP full dose for any reason
- Previous treatment with a bispecific antibody
- Current or past history of DLBCL in the CNS (confirmed by CSF analysis)
- Steroids treatment (\> 1 mg/kg/d for one week) before inclusion
- History of anaphylactic reactions to human, chimeric, or mouse monoclonal antibodies or to any components of the product.
- Prior allogeneic HSCT
- Patients with known acute infection or reactivation of a latent infection, whether bacterial, viral (including, but not limited to, EBV, cytomegalovirus (CMV), hepatitis B, hepatitis C, HIV and SARS-CoV-2), fungal...
- History of other malignancies, except: i) malignancy treated with curative intent and with no recurrence over the last 3 years ii) adequately treated non-melanoma skin cancer without evidence of disease iii) adequately...
- Prior solid organ transplantation
- History of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents, as follows:
- Grade ≥ 3 adverse events with the exception of Grade 3 endocrinopathy managed with replacement therapy
- Grade 1-2 adverse events that did not resolve to baseline after treatment discontinuation
- Current uncontrolled autoimmune disease\
- History of human immunodeficiency virus
- Hepatitis B or C seropositivity (unless clearly due to vaccination)
- Pregnant or breastfeeding women
- Unwilling or unable to participate in all required study evaluations and procedures.
- Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form and authorization to use protected health information (in accordance with national and local subject...
- Persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure (guardianship, curatorship, legal protection), persons under psychiatric care
- Fertile male patients who cannot or do not wish to use an effective method of contraception, during and for 12 months after the final treatment used for the purposes of the study.
- Patients with history of macrophage activation syndrome (MAS) / hemophagocytic lymphohistiocytosis (HLH)
- LVEF \< 50% as determined by echocardiography or multiple uptake gated acquisition (MUGA) scan, significant or extensive cardiovascular disease such as New York HeartAssociation Class III or IV cardiac disease or...
- Abnormal screening laboratory values as defined as following: a) ALT (SGOT) and/or ALT (SGPT) and/or ALP ≥ 3 x upper limit of normal (ULN); b) Total bilirubin ≥ 1.5 x ULN, unless due to Gilbert's disease; c) Creatinine...
- Patient with history of confirmed progressive multifocal leukoencephalopathy (PML)
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
- Major surgery or significant traumatic injury \< 28 days prior to the obinutuzumab infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment
- Administration of a live, attenuated vaccine within 4 weeks before obinutuzumab infusion
- Treatment with another investigational agent or participating in another trial within 30 days prior to entering the study
- Clinically significant history of liver disease or cirrhosis
- Pregnant or breast-feeding or intending to become pregnant during the study
- No affiliation to social security
- Inability to comply with protocol mandated hospitalization and restrictions.
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Bayonne, France
- Clermont-Ferrand, France
- Grenoble, France
- Lille, France
- Limoges, France
- Lyon, France
- Montpellier, France
- Paris, France
- Pessac, France
- Pierre-Bénite, France
- Reims, France
- Rennes, France
- Rouen, France
- Strasbourg, France
- Toulouse, France
- Tours, France
- Vandœuvre-lès-Nancy, France
- Versailles, 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 Amiens, France; Angers, France; Bayonne, France; Clermont-Ferrand, France; Grenoble, France; Lille, 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.