Actively Recruiting
Tafasitamab, Acalabrutinib, and Obinutuzumab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Led by OHSU Knight Cancer Institute · Updated on 2025-11-06
27
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
Sponsors
O
OHSU Knight Cancer Institute
Lead Sponsor
O
Oregon Health and Science University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase Ib trial tests the safety and effectiveness of tafasitamab, acalabrutinib, and obinutuzumab in treating patients with previously untreated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). CLL and SLL are types of cancer that develops from a specific white blood cell called B cells or B lymphocytes. Tafasitamab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Acalabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell cancers such as CLL at abnormal levels. This may help keep cancer cells from growing and spreading. Giving tafasitamab, acalabrutinib, and obinutuzumab may kill more cancer cells in patients with previously untreated CLL and SLL.
CONDITIONS
Official Title
Tafasitamab, Acalabrutinib, and Obinutuzumab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent is provided before any study procedures
- Age 18 years or older, all genders and races included
- Ability to swallow and retain oral medication
- Documented previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) diagnosed by standard criteria
- Detectable immunoglobulin heavy gene signature for minimal residual disease testing
- Meets at least one treatment criterion based on disease progression or symptoms per guidelines
- For SLL, measurable lymphadenopathy of at least 2.0 cm in longest diameter by imaging
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Life expectancy greater than 12 months
- Absolute neutrophil count above 1,000/mm3
- Platelet count above 50,000/mm3
- Kidney and liver function within specified limits
- Negative for active hepatitis C and B infections, with certain allowances for past infections
- Individuals of childbearing potential must have negative pregnancy test and agree to contraception during and 6 months after treatment
- Agreement to stop breastfeeding and refrain from ova or sperm donation during treatment and 6 months after
You will not qualify if you...
- Prior or current diagnosis of other blood cancers
- Any previous treatment directed at CLL except limited corticosteroid use that can be stopped
- Known allergy or hypersensitivity to any study drugs or related antibodies
- Receipt of live vaccines within 14 days before enrollment
- History of other solid tumors unless disease-free for over 2 years with exceptions
- History of progressive multifocal leukoencephalopathy (PML)
- Active autoimmune diseases requiring high-dose steroids except certain blood-related autoimmune conditions
- Active systemic infections excluding localized skin or nail infections
- Positive for HIV infection
- Known transformation of CLL to aggressive lymphoma
- Known bleeding disorders
- Use of blood thinners that cannot be stopped before treatment
- Recent use of drugs that affect cytochrome P450 3A without special approval
- Severe or uncontrolled medical conditions including heart failure, poor heart function, uncontrolled atrial fibrillation, recent heart attack, uncontrolled hypertension, or significant vascular disease
- Any other medical condition that would make participation unsafe or inappropriate
AI-Screening
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Trial Site Locations
Total: 1 location
1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
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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