Tafasitamab, Acalabrutinib, and Obinutuzumab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT05943496
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acalabrutinib — DRUG
    Given PO
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow biopsy and/or aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy and/or aspiration
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Echocardiography — PROCEDURE
    Undergo ECHO
  • Obinutuzumab — BIOLOGICAL
    Given IV
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Tafasitamab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Oct 2, 2023
Status verified
Nov 2025
Primary completion
Jan 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (tafasitamab, obinutuzumab, acalabrutinib)
    See Detailed DescriptionPatients receive obinutuzumab IV over a rate titrated up to 400 mg/hour on days 1, 2, 8, and 15 for cycle 1 then on day 1 for cycles 2-6 and tafasitamab IV over 1.5-2 hours on days 1, 4, 8, 15, and 22 for cycle 2, on days 1, 8, 15, and 22 for cycles 3-4, and on days 1 and 15 for cycles 5-7. Patients also receive acalabrutinib PO BID in each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and CT throughout the trial. Patients may undergo an ECHO at baseline as clinically indicated and may also undergo bone marrow biopsy and/or aspiration at baseline and/or follow-up.

Primary Outcome Measure

Incidence of dose limiting toxicities (DLTs) [ Time Frame: From first dose of tafasitamab (cycle 2, day 1) to end of cycle 6 (C6D28) up to 2 years. (cycle length = 28 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
OHSU Knight Cancer InstitutePortlandOregon97239
OHSU Knight Cancer Clinical Trials Hotline
[email protected]
503-494-1080
Stephen E. Spurgeon (PRINCIPAL_INVESTIGATOR)

Find similar trials in Portland, OR

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
OHSU Knight Cancer Institute· Portland, OR

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