Health TrialsbyHealthPanel

Pirtobrutinib for the Treatment of Elderly Patients With Chronic Lymphocytic Leukemia

ConditionChronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age75+
SponsorJennifer Woyach

About this trial

This phase II trial studies how well pirtobrutinib works in treating elderly patients with chronic lymphocytic leukemia (CLL). Bruton tyrosine kinase (BTK) inhibitors such as ibrutinib, acalabrutinib, and zanubrutinib work by blocking the action of the BTK protein that signals cancer cells to multiply. These are very effective, tolerable, and commonly used to treat people with CLL, but they may lead to drug resistance over time. Pirtobrutinib, also a BTK inhibitor, may work better in treating elderly patients with CLL.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women ≥ 75 years of age

Diagnosis of CLL/small lymphocytic lymphoma (SLL) meeting criteria established in the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines

Must be treatment-naive: Received no prior chemotherapy, immunotherapy, or targeted therapy for the treatment of CLL, with the exceptions of palliative loco-regional radiotherapy, rituximab for autoimmune conditions, or corticosteroids for symptoms control. For radiation, broad field radiation (≥ 30% of bone marrow or whole brain radiotherapy) must be completed 14 days before study enrollment; palliative limited field radiation must be completed 7 days prior to study enrollment. For rituximab, washout of 2 weeks is required prior to study enrollment

Must require treatment according to 2018 iwCLL guidelines

Disqualifiers

Active Richter's transformation (i.e. within 6 months of active therapy, or requiring treatment for Richter's transformation)

Malabsorption syndrome or inability to absorb pirtobrutinib

Patients with Class III or Class IV heart failure by New York Heart Association, those with unstable angina, those with uncontrolled arrhythmia, and those patients who experienced an myocardial infarction (MI) within 3 months of screening or acute coronary syndrome within 2 months of screening are not eligible

Documented left ventricular ejection fraction (LVEF) by any method of ≤ 40% in the 12 months prior to randomization

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood samples

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow biopsy and aspiration

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy and aspiration

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

  • Pirtobrutinib

    Drug

    Given PO

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Treatment (pirtobrutinib)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Rate of treatment discontinuation

Will be calculated among all evaluable patients. The rates will be provided together with 95% exact confidence intervals.

Time frame
Up to 12 cycles (Cycle length = 28 days)
2

Overall response rate

Will be determined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL). Will be calculated among all evaluable patients. The rates will be provided together with 95% exact confidence intervals.

Time frame
Up to 12 cycles (Cycle length = 28 days)

Secondary outcomes

1

Progression-free survival

Will be estimated using the method of Kaplan-Meier.

Time frame
From treatment start to the date of the corresponding event, assessed up to 5 years
2

Overall survival

Will be estimated using the method of Kaplan-Meier.

Time frame
From treatment start to the date of the corresponding event, assessed up to 8 years after completion of study treatment
3

Duration of response

Will be estimated using the method of Kaplan-Meier.

Time frame
From the date where the first response is achieved to the date of progression or death, assessed up to 8 years after completion of study treatment
4

Time to next treatment

Will be estimated using the method of Kaplan-Meier.

Time frame
From treatment start to the date of the corresponding event, assessed up to 8 years after completion of study treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jennifer Woyach

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

Source ClinicalTrials.gov
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