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New treatment option for MCL
Official title Glofitamab Combined With Lenalidomide in High Risk Patients With Relapsed or Refractory Mantle Cell Lymphoma
ClinicalTrials.gov ID: NCT07460362
What this study is testing
What is Glofitamab?
Glofitamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for mcl.
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
- A single-arm, open-label, multi-center clinical study of glofitamab combined with lenalidomide in high risk patients with relapsed or refractory Mantle Cell Lymphoma previously treated with a BTK Inhibitor. Patients will be eligible if they have received one or more prior lines of therapy, one of which must have been a BTKi.
- 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 to 80
You may be able to join if
- Signed Informed Consent Forms
- Age: \>= 18 to 80 years
- Eastern Cooperative Oncology Group =\< 2
- Diagnosis of MCL established by histologic assessment
- Previously treated with at least one prior line of systemic therapy for mantle cell lymphoma.
You likely can't join if
- Already enrolled in other Ongoing treatment or non-treatment R/R MCL clinical trials;
- Currently receiving immunosuppressive treatment for other diseases;
- Previous treatment with lenalidomide;
- Combined with other malignant tumors within 3 years;
- The researcher determines that they are not suitable to participate in this study;
- Serious mental or neurological disorders that affect informed consent and/or the expression or observation of adverse reactions;
See the full eligibility criteria
- Signed Informed Consent Forms
- Age: \>= 18 to 80 years
- Eastern Cooperative Oncology Group =\< 2
- Diagnosis of MCL established by histologic assessment
- Previously treated with at least one prior line of systemic therapy for mantle cell lymphoma.
- Prior therapy have included a BTK inhibitor, including ibrutinib, zanubrutinib, obrutinib, acalabrutinib and various BTKi in clinical trials. BTki exposure is required, which include BTKi failure or intolerance. BTKi...
- At least one high risk features as classified:
- Blastoid/pleomorphic variants ✔ Ki67 ≥50% ✔ TP53 mutation or deletion
- Bulky disease (defined as any lesion ≥7.5 cm on the screening computed tomography [CT] scan）
- Patients that did not achieve a CR with their first-line treatment
- early disease progression (POD24) ✔ patients with relapse and refractory treatment above 3 lines
- Measurable lesions on cross-sectional imaging documented by diagnostic imaging(MRI, CT or PET-CT), （GTD）≥1.5 cm
- Adequate liver function : Total bilirubin =\< 3 x upper limit of normal (ULN) (unless has Gilbert's disease), Aspartate aminotransferase (AST) =\< 5.0 x ULN, Alanine aminotransferase (ALT) =\< 5.0 x ULN
- Already enrolled in other Ongoing treatment or non-treatment R/R MCL clinical trials;
- Currently receiving immunosuppressive treatment for other diseases;
- Previous treatment with lenalidomide;
- Combined with other malignant tumors within 3 years;
- The researcher determines that they are not suitable to participate in this study;
- Serious mental or neurological disorders that affect informed consent and/or the expression or observation of adverse reactions;
- Have a history of major or extensive cardiovascular disease, such as New York Heart Association class III or Grade IV heart disease or objective assessment, myocardial infarction, unstable arrhythmia or unstable angina...
- Recent major surgery (within 4 weeks before the start of the first cycle);
- Active autoimmune diseases with poor treatment control;
- Any active infection that may affect the safety of the participant, including bacterial, fungal and various viral infections, occurred within 7 days before the first day of cycle 1;
- Positive SARS-CoV-2 PCR test within 7 days prior to enrollment
- Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HBsAg] serology) Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B...
- Positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing) Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
- A history of severe deep vein thrombosis event or pulmonary embolism within 6 months
- Patient follow-up was not possible.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
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 to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. 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.