Actively Recruiting
A Phase 2 Trial of GlOfitamab anD pIrtobrutinib in Mantle Cell Lymphoma Patients With Prior BTK Inhibitor Exposure.
Led by Australasian Leukaemia and Lymphoma Group · Updated on 2024-01-08
42
Participants Needed
2
Research Sites
702 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the safety and response of combining Pirtobrutinib and Glofitimab in patients with relapsed MCL. The main question it aims to answer are: * Will additive and synergistic effects be observed when using a combination of glofitamab and pirtobrutinib? * Will this combination be safe and lead to high complete- and remission rates with no residual disease? Pirtobrutinib will be given to all participants as an oral tablet for the duration of the entire study. Participants will receive other treatment in 3 phases: 1. Treatment Ramp-Up 1. Treatment with Obinutuzumab by Intravenous (IV) 2. An initial dose level of Glofitamab will evaluate step-up dosing. If excessive adverse events are observed, a lower initial dose will be used. 2. Fixed course combination phase: Treatment with Glofitamab by IV 3. Maintenance phase: Glofitamab is discontinued. 200mg oral daily
CONDITIONS
Official Title
A Phase 2 Trial of GlOfitamab anD pIrtobrutinib in Mantle Cell Lymphoma Patients With Prior BTK Inhibitor Exposure.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed diagnosis of mantle cell lymphoma according to WHO 2016 criteria
- At least one measurable disease site not previously treated with radiation
- Life expectancy of at least 18 weeks
- Prior use of a BTK inhibitor with relapse, progression, or insufficient response
- Recovery to Grade 1 or less from prior therapy adverse events except alopecia, peripheral neuropathy, and lymphopenia
- ECOG performance status between 0 and 2
- Adequate washout from prior therapies including radiation and certain drugs
- Ability to take oral medications
- Willing and able to provide informed consent
- Commitment to use effective birth control during and for six months after treatment
- Negative pregnancy test for women of childbearing potential within seven days before enrollment
- Adequate blood clotting function
- Adequate liver, kidney, and blood function as specified
- Availability of sufficient tissue for central review
You will not qualify if you...
- Unable to comply with required hospital stays
- Recent allogeneic transplant within 12 months, chronic graft-versus-host disease, or immunosuppressive therapy
- Autologous transplant or CAR-T therapy within 6 weeks
- Active central nervous system involvement by lymphoma
- Prior treatment with pirtobrutinib or resistance to CD20xCD3 bispecific antibodies
- Severe allergy to study drugs or their ingredients
- Stroke or brain bleeding within six months
- Live vaccination within 28 days
- Major surgery or serious injury within 28 days, or planned during treatment
- Significant heart disease including unstable angina, recent heart attack, low heart function, severe heart failure, or uncontrolled arrhythmias
- Prolonged QT interval on ECG
- Known HIV infection
- Active hepatitis B or C infection
- Active cytomegalovirus infection
- Pregnancy, lactation, or breastfeeding
- Significant malabsorption affecting drug absorption
- Uncontrolled infections or active serious diseases
- Active autoimmune blood conditions requiring recent new or increased treatment unless related to lymphoma
- Active second cancer unless in remission with life expectancy over 2 years
- Current use of strong CYP3A4 or P-gp inhibitors or inducers
- Need for therapeutic anticoagulation with warfarin or vitamin K antagonists
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Peter MacCallum Cancer Centre
Parkville, Victoria, Australia, 3050
Actively Recruiting
2
Sir Charles Gairdener
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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