Actively Recruiting
Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients
Led by M.D. Anderson Cancer Center · Updated on 2026-05-05
30
Participants Needed
1
Research Sites
222 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
L
Loxo Oncology
Collaborating Sponsor
AI-Summary
What this Trial Is About
To learn if the combination of pirtobrutinib (also called LOXO-305) and venetoclax can help to control mantle cell lymphoma (MCL) that is relapsed (has come back) or refractory (has not responded to therapy).
CONDITIONS
Official Title
Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of mantle cell lymphoma by tissue biopsy, with or without chromosome translocation t(11;14) or cyclin D1 overexpression
- Able to take oral medications
- Relapsed mantle cell lymphoma, including prior therapy with BTK inhibitors or anti CD19-CART therapy, without prior venetoclax
- Willing and able to provide signed informed consent
- Age 18 years or older at consent
- At least one site of measurable disease by imaging or acceptable methods
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Disease free of prior malignancies except certain treated skin, cervical, breast, or prostate cancers in remission
- Prothrombin time and partial thromboplastin time not exceeding 1.2 times institutional upper limit
- Adequate bone marrow function without recent transfusion or growth factor support
- Adequate organ function including creatinine clearance ≥30 mL/min, bilirubin ≤1.5x ULN (or up to 3x with specific conditions), and liver enzymes <3x ULN (or <5x with metastases)
- Projected life expectancy of more than 12 weeks related to lymphoma
- Female patients must be surgically sterile, postmenopausal, or have negative pregnancy test within 7 days prior to treatment
- Use of effective contraception for women of childbearing potential and men with partners of childbearing potential during and for 6 months after treatment
- Required washout periods for prior therapies before starting study treatment
- Prior treatment-related adverse events recovered to Grade 1 or less except alopecia and Grade 2 peripheral neuropathy
You will not qualify if you...
- Known central nervous system involvement by lymphoma unless previously treated and stable with no current disease
- History of bleeding disorders or recent stroke/brain hemorrhage within 6 months
- Recent live vaccination within 28 days
- Known allergy to pirtobrutinib, venetoclax, or related compounds
- Prior major bleeding or serious arrhythmias on BTK inhibitors
- Pregnant or breastfeeding females
- Uncontrolled HIV infection or active hepatitis B or C infection
- Other uncontrolled infections or significant medical conditions posing risk
- Significant cardiovascular diseases including recent heart attacks or severe heart failure
- Prolonged QT interval on ECG
- Other active cancers within 1 year except certain treated cancers in remission
- Gastrointestinal conditions affecting drug absorption
- Allergies to xanthine oxidase inhibitors or rasburicase
- Severe medical or psychiatric conditions increasing study risk
- No concurrent anticancer therapies or recent major surgery within specified washout periods
- Active autoimmune blood disorders requiring recent new or increased therapy
- Use of certain strong CYP3A4 or P-gp inhibitors/inducers and grapefruit products
- Use of warfarin or equivalent vitamin K antagonists
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
P
Preetesh Jain, MD, DM, PhD
CONTACT
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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