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New treatment option for Mantle Cell Lymphoma
Official title Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
ClinicalTrials.gov ID: NCT06252675
What this study is testing
What is Obinutuzumab?
Obinutuzumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for mantle cell lymphoma.
Also referred to as Anti-CD20 Monoclonal Antibody R715, huMAB(CD20).
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 phase II trial tests the safety and effectiveness of glofitamab given in combination with pirtobrutinib in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Glofitamab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 94 weeks
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
- Age ≥ 18 years at the time of signing the informed consent form.
- Have a life expectancy (in the opinion of the investigator) of at least 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status \ 60%).
- History of previously treated MCL meeting the following criteria: Relapsed after or failed to respond to at least one prior line of systemic therapy...
- At least one bi-dimensionally measurable nodal lesion ( \> 1.5 cm in its largest dimension by PET/CT scan), or at least one bi-dimensionally...
You likely can't join if
- Pregnant, or intention of becoming pregnant during the study or within 18 months after treatment with obinutuzumab or 2 months after the last dose of...
- Participants should avoid chest-feeding until at least 1 week after discontinuing pirtobrutinib.
- Have received the following treatments/procedures prior to study entry:
- Participants who experienced a major bleeding event or grade ≥ 3 arrhythmia on prior treatment with a BTK inhibitor. NOTE: Major bleeding is defined...
- Participants who discontinued a covalent BTK inhibitor due to disease progression or relapse. NOTE: Participants who discontinued covalent BTK...
- Any grade 3 or higher non-hematologic toxicity, except a major bleeding event or grade \>= 3 arrhythmia which are exclusion criteria
See the full eligibility criteria
Who can join
- Age ≥ 18 years at the time of signing the informed consent form.
- Have a life expectancy (in the opinion of the investigator) of at least 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status \ 60%).
- History of previously treated MCL meeting the following criteria: Relapsed after or failed to respond to at least one prior line of systemic therapy including anti-CD20 monoclonal antibody and alkylator-containing...
- At least one bi-dimensionally measurable nodal lesion ( \> 1.5 cm in its largest dimension by PET/CT scan), or at least one bi-dimensionally measurable extranodal lesion ( \> 1.0 cm in its largest dimension by PET/CT...
- Availability of leftover tissue from the time of progression for pathology confirmation and correlative studies. Note: Formalin fixed paraffin embedded blocks are preferred. If blocks are not available, 12-15 slides...
- Hemoglobin ≥ 9 g/dL (Independent of transfusions and within 7 days prior to screening assessment).
- Absolute neutrophil count \>= 1.0 x 10\^9/L (Independent of growth factor support and within 7 days prior to screening assessment).
- Platelets ≥ 75 x 10\^9/L or \>= 50 x 10\^9/L if due to bone marrow involvement (Independent of transfusions and within 7 days prior to screening assessment, and independent of growth factor support and within 7 days...
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (or ≤ 3 x ULN for participants with Gilbert syndrome, or \<= 3 x ULN if due to underlying lymphoma).
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase (SGOT)) \<= 2.5 X institutional upper limit of normal.
- Alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase (SGPT)) \<= 2.5 X institutional upper limit of normal.
- Creatinine clearance \>= 50 mL/min (by Cockcroft-Gault formula).
- Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) \<= 1.5 x ULN.
- Prothrombin (PT) or (international normalized ratio (INR) \<= 1.5 x ULN.
- In women of childbearing potential, negative serum pregnancy test within 7 days prior to study treatment and either abstinence or use of highly effective contraception methods from the time of screening for at least 18...
- For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm, with female partners of childbearing potential or pregnant female partners, men must remain abstinent or...
- Willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- Participants with prior treatment-related adverse events (AEs) must have recovered to grade \<= 1 with the exception of alopecia and grade 2 peripheral neuropathy.
- Participants must be able to swallow oral medications.
- Participants with positive hepatitis B core antibody (anti-HBc) and negative hepatitis B surface antigen (HBsAg) require a negative hepatitis B polymerase chain reaction (PCR) evaluation before initiating study...
- Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV...
What rules you out
- Pregnant, or intention of becoming pregnant during the study or within 18 months after treatment with obinutuzumab or 2 months after the last dose of glofitamab, or 3 months after treatment with tocilizumab, whichever...
- Participants should avoid chest-feeding until at least 1 week after discontinuing pirtobrutinib.
- Have received the following treatments/procedures prior to study entry:
- Participants who experienced a major bleeding event or grade ≥ 3 arrhythmia on prior treatment with a BTK inhibitor. NOTE: Major bleeding is defined as bleeding having one or more of the following features: potentially...
- Participants who discontinued a covalent BTK inhibitor due to disease progression or relapse. NOTE: Participants who discontinued covalent BTK inhibitor therapy due to intolerance will not be excluded. Covalent BTK...
- Any grade 3 or higher non-hematologic toxicity, except a major bleeding event or grade \>= 3 arrhythmia which are exclusion criteria
- Any grade 1 or higher non-hematologic toxicity that lasted longer than 7 days or recurred
- Any grade 4 hematologic toxicity
- Neutropenic fever
- Discontinuation due to drug interaction/expected toxicity with resolution of prior covalent BTK inhibitor-related toxicities
- Any CD20/CD3-directed bispecific antibodies for treatment of lymphoma
- Allogeneic stem cell transplant (SCT) within 6 months or on active immunosuppression or active graft versus host disease (GVHD)
- Solid organ transplantation
- Have received the following treatments/procedures prior to study entry whether investigational or approved, within the respective time periods prior to initiation of study treatment:
- Radiotherapy within 2 weeks prior to the first dose of study treatment. Note: If participants have received radiotherapy within 4 weeks prior to the first study treatment administration, participants must have at least...
- Autologous SCT within 90 days prior to first study treatment
- Chimeric antigen receptor (CAR) T-cell therapy within 60 days before first study treatment or if ongoing toxicity ≥ grade 2
- Use of monoclonal antibodies or antibody-drug conjugates within 4 weeks prior to first study treatment
- Use of radioimmunoconjugates within 12 weeks prior to first study treatment
- Systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks or five half-lives (whichever is...
- Live, attenuated vaccine within 4 weeks before first dose of study treatment, or in whom it is anticipated that such a live attenuated vaccine will be required during the study period or within 5 months after the final...
- Evidence of active central nervous system (CNS) lymphoma or leptomeningeal infiltration
- Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Note: Participants with a history of stroke who have not experienced a stroke or transient ischemic attack...
- Active second malignancy unless the patient is in remission and has a life expectancy \> 2 years.
- Major surgical procedure (under general anesthesia) within 30 days of day 1 of protocol therapy. Note: If a patient had major surgery, they must have recovered adequately from any toxicity and/or complications from the...
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins).
- History of autoimmune disease, including but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease...
- Significant or extensive history of cardiovascular disease such as New York Heart Association class III or IV or objective class C or D cardiac disease, myocardial infarction within the previous 6 months, unstable...
- Prolongation of the QTc for heart rate using Fridericia's Formula (QTcF) \> 470 msec. Note: Correction of QTc for underlying bundle branch block is permissible.
- Significant pulmonary disease that is expected to interfere with therapy.
- History of confirmed progressive multifocal leukoencephalopathy (PML).
- Known active infection (including Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)), or reactivation of a latent infection, whether bacterial, viral (including, but not limited to, Epstein-Barr virus (EBV)...
- Participants requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist.
- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).
- Participants who have tested positive for human immunodeficiency virus (HIV) are excluded due to risk of opportunistic infections with both HIV and BTK inhibitors. For participants with unknown HIV status, HIV testing...
- Participants with a history of bleeding diathesis.
- Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study drug.
- A known hypersensitivity to any of the excipients of pirtobrutinib or to any of the intended study medications.
- Participants requiring ongoing therapy with strong Cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or inducers will be excluded. For participants who are able to discontinue therapy with a strong CYP3A...
The study team makes the final eligibility decision.
Where it's taking place
- Davis, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
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 study runs about 94 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Davis, California, United States; Los Angeles, California, United States; San Francisco, California, United States. 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.