60 Participants Needed

Pirtobrutinib + Obinutuzumab for Chronic Lymphocytic Leukemia

Recruiting at 3 trial locations
MF
HA
Overseen ByHeather A Walker, MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

What is the purpose of this trial?

This study will evaluate fixed-duration therapy with pirtobrutinib and obinutuzumab given over 12 cycles (approximately 1 year) as first-line treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL or SLL).

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on certain immunosuppressive drugs or investigational agents, and there are restrictions on recent use of high-dose steroids and live vaccines.

What data supports the effectiveness of the drug combination Pirtobrutinib and Obinutuzumab for treating Chronic Lymphocytic Leukemia?

Obinutuzumab, a type of antibody, has shown to improve survival rates in patients with Chronic Lymphocytic Leukemia (CLL) when combined with other treatments. It works by helping the immune system target and kill cancer cells more effectively.12345

Is the combination of Pirtobrutinib and Obinutuzumab safe for treating chronic lymphocytic leukemia?

Obinutuzumab, when used alone or with chemotherapy, has shown a manageable safety profile in chronic lymphocytic leukemia patients, with common side effects including low white blood cell counts and infusion-related reactions. Careful monitoring and management strategies are recommended to handle these side effects.26789

What makes the drug combination of Pirtobrutinib and Obinutuzumab unique for treating chronic lymphocytic leukemia?

Pirtobrutinib is a noncovalent Bruton's tyrosine kinase inhibitor (BTKi) that can be effective for patients who do not respond to other BTK inhibitors, making it a promising option for those with resistant forms of chronic lymphocytic leukemia. When combined with Obinutuzumab, it offers a novel approach that may enhance treatment effectiveness, especially for patients who have limited options.310111213

Research Team

Inhye Ahn, MD - Dana-Farber Cancer ...

Inhye Ahn

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

Adults over 18 with chronic lymphocytic leukemia or small lymphocytic lymphoma who need treatment and meet specific health guidelines. They should have no prior CLL/SLL treatments, be able to take pills, and have measurable disease. Excluded are those with other serious illnesses, recent major surgery, active infections like hepatitis B/C or HIV, bleeding disorders, significant heart issues, or pregnant/breastfeeding women.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document
I can take care of myself and am up and about more than half of my waking hours.
Currently have an indication for treatment as defined by the following 2018 IWCLL guidelines
See 5 more

Exclusion Criteria

Receiving any other investigational agents
I have a condition that affects how my body absorbs medication.
I have an active, uncontrolled immune system disorder affecting my blood cells.
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive 6 cycles of pirtobrutinib alone followed by 6 cycles of pirtobrutinib-obinutuzumab combination therapy

12 months
Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Annual visits (in-person)

Retreatment

Participants with progressive CLL/SLL during follow-up will receive continuous pirtobrutinib monotherapy

As needed

Treatment Details

Interventions

  • Obinutuzumab
  • Pirtobrutinib
Trial Overview The trial is testing a combination of two drugs—Pirtobrutinib and Obinutuzumab—for about a year as the first line of attack against chronic lymphocytic leukemia/small lymphocytic lymphoma. The effectiveness of this fixed-duration therapy given over 12 cycles will be evaluated.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Pirtobrutinib-ObinutuzumabExperimental Treatment2 Interventions
Eligible participants will receive initial treatment with pirtobrutinib and obinutuzumab for 12 cycles. Participants with progressive chronic lymphocytuc leukemia or small lymphocytic lymphoma during the off-treatment follow-up will receive continuous pirtobrutinib monotherapy.

Obinutuzumab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Gazyva for:
  • Chronic Lymphocytic Leukemia (CLL)
  • Follicular Lymphoma
🇪🇺
Approved in European Union as Gazyva for:
  • Chronic Lymphocytic Leukemia (CLL)
  • Follicular Lymphoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

Inhye Ahn

Lead Sponsor

Trials
2
Recruited
60+

Loxo Oncology, Inc.

Industry Sponsor

Trials
72
Recruited
11,600+

Jacob Van Naarden

Loxo Oncology, Inc.

Chief Executive Officer since 2019

A.B. in Molecular Biology from Princeton University

Dr. Jennifer Low

Loxo Oncology, Inc.

Chief Medical Officer since 2014

MD and PhD from Georgetown University; Undergraduate degree from California Institute of Technology

Findings from Research

Obinutuzumab, a novel humanized anti-CD20 antibody, has been shown to significantly improve overall survival when combined with chlorambucil in untreated comorbid patients with chronic lymphocytic leukemia (CLL).
This antibody enhances antibody-dependent cellular cytotoxicity and directly induces cell death more effectively than previous type I antibodies, marking a significant advancement in CLL treatment options.
Targeted treatment for chronic lymphocytic leukemia: clinical potential of obinutuzumab.Smolej, L.[2020]
Obinutuzumab treatment in patients with chronic lymphocytic leukemia and follicular lymphoma led to a significant decrease in natural killer (NK) cell levels in peripheral blood, dropping below the normal range.
Subcutaneous rituximab resulted in a less pronounced reduction of NK cells compared to intravenous rituximab, suggesting that the method of administration may influence NK cell levels during treatment.
Battle of Thermopylae: 300 Spartans (natural killer cells plus obinutuzumab) versus the immortal warriors (chronic lymphocytic leukemia cells) of Xerxes' army.García-Muñoz, R., Nájera, MJ., Feliu, J., et al.[2022]
Ibrutinib has shown high effectiveness as a first-line treatment for chronic lymphocytic leukemia in real-world settings, with 12-month overall survival rates between 95% and 96% and progression-free survival rates ranging from 89% to 93% across various studies involving 112 to 2033 patients.
The treatment demonstrated a strong response rate, with 71% to 90% of patients responding positively, and a significant majority (91% at 12 months and 87% at 24 months) did not require new treatment, indicating its sustained efficacy.
Systematic Literature Review of Real-World Effectiveness Results Data for First-Line Ibrutinib in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma.Lee, P., Kistler, KD., Douyon, L., et al.[2023]

References

Targeted treatment for chronic lymphocytic leukemia: clinical potential of obinutuzumab. [2020]
Battle of Thermopylae: 300 Spartans (natural killer cells plus obinutuzumab) versus the immortal warriors (chronic lymphocytic leukemia cells) of Xerxes' army. [2022]
Systematic Literature Review of Real-World Effectiveness Results Data for First-Line Ibrutinib in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. [2023]
Obinutuzumab in chronic lymphocytic leukemia: design, development and place in therapy. [2018]
Obinutuzumab for the treatment of chronic lymphocytic leukemia and other B-cell lymphoproliferative disorders. [2023]
Safety and efficacy of obinutuzumab alone or with chemotherapy in previously untreated or relapsed/refractory chronic lymphocytic leukaemia patients: Final analysis of the Phase IIIb GREEN study. [2021]
Obinutuzumab plus bendamustine in previously untreated patients with CLL: a subgroup analysis of the GREEN study. [2023]
Obinutuzumab (GA101) plus CHOP or FC in relapsed/refractory follicular lymphoma: results of the GAUDI study (BO21000). [2022]
Managing Infusion-Related Reactions for Patients With Chronic Lymphocytic Leukemia Receiving Obinutuzumab. [2017]
10.United Statespubmed.ncbi.nlm.nih.gov
Ibrutinib (imbruvica): a novel targeted therapy for chronic lymphocytic leukemia. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Pirtobrutinib: a new hope for patients with BTK inhibitor-refractory lymphoproliferative disorders. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
First-Line Ibrutinib Confirmed for CLL. [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
Targeted drugs in concert with chemo: opposites attract. [2021]
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