30 Participants Needed

Obinutuzumab + Ibrutinib for Indolent Non-Hodgkin's Lymphomas

UM
Overseen ByUbaldo Martinez-Outschoorn, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
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

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot use warfarin, other vitamin K antagonists, or strong CYP3A inhibitors. You should also be off corticosteroids 2 weeks before starting the trial.

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

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are using warfarin, other vitamin K antagonists, or require treatment with a strong CYP3A inhibitor. You should also be off corticosteroids for 2 weeks before joining the study.

What data supports the idea that Obinutuzumab + Ibrutinib for Indolent Non-Hodgkin's Lymphomas is an effective treatment?

The available research does not provide specific data on the combination of Obinutuzumab and Ibrutinib for Indolent Non-Hodgkin's Lymphomas. However, it does mention that Ibrutinib, when combined with another drug called Rituximab, showed positive results in treating a similar condition called follicular lymphoma. In this study, a high percentage of patients responded well to the treatment, with many experiencing complete responses. This suggests that Ibrutinib can be effective in treating certain types of lymphomas, but there is no direct data on its combination with Obinutuzumab for Indolent Non-Hodgkin's Lymphomas in the provided information.12345

What data supports the effectiveness of the drug combination of Obinutuzumab and Ibrutinib for Indolent Non-Hodgkin's Lymphomas?

Research shows that Ibrutinib, when combined with another similar drug, Rituximab, was effective in treating follicular lymphoma, a type of non-Hodgkin's lymphoma, with high response rates and good survival outcomes. Additionally, Obinutuzumab has been approved for use in chronic lymphocytic leukemia, indicating its potential effectiveness in related conditions.12345

What safety data exists for the treatment of Obinutuzumab and Ibrutinib in indolent non-Hodgkin's lymphomas?

Existing safety data for Obinutuzumab and Ibrutinib in indolent non-Hodgkin's lymphomas includes findings from several studies. Obinutuzumab, when used in combination with bendamustine, showed a generally manageable tolerability profile with mild to moderate infusion-related reactions and neutropenia as common adverse events. In the GAUDI study, Obinutuzumab combined with chemotherapy (G-CHOP or G-FC) resulted in high response rates and an acceptable safety profile, with infusion-related reactions and neutropenia being the most common adverse events. Ibrutinib, when studied in combination with nivolumab, was assessed for safety in relapsed or refractory B-cell malignancies, indicating ongoing evaluation of its safety profile in combination therapies.23678

Is the combination of Obinutuzumab and Ibrutinib generally safe for humans?

Obinutuzumab and Ibrutinib have been studied for safety in various conditions. Obinutuzumab is generally well-tolerated, with mild to moderate infusion-related reactions being common, and neutropenia (low white blood cell count) as a more serious side effect. Ibrutinib has been tested in combination with other drugs and is considered safe, but specific safety data for the combination of Obinutuzumab and Ibrutinib is limited.23678

Is the drug combination of Obinutuzumab and Ibrutinib promising for treating indolent non-Hodgkin's lymphomas?

Yes, the drug combination of Obinutuzumab and Ibrutinib is promising for treating indolent non-Hodgkin's lymphomas. Obinutuzumab has shown to significantly extend the time patients live without the disease getting worse, especially in those who did not respond well to previous treatments. This makes it a valuable option for patients with this type of lymphoma.236910

How is the drug combination of Obinutuzumab and Ibrutinib unique for treating indolent non-Hodgkin's lymphomas?

The combination of Obinutuzumab and Ibrutinib is unique because Obinutuzumab is a specially engineered antibody that targets CD20 on cancer cells, while Ibrutinib blocks a protein that helps cancer cells grow. This dual approach may offer a new option for patients who have not responded to other treatments.236910

What is the purpose of this trial?

This phase II trial studies how well obinutuzumab and ibrutinib work as front line therapy in treating patients with indolent non-Hodgkin's lymphoma. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving obinutuzumab and ibrutinib may work better in treating patients with non-Hodgkin's lymphomas.

Research Team

UM

Ubaldo Martinez-Outschoorn, MD

Principal Investigator

Sidney Kimmel Cancer Center at Thomas Jefferson University

Eligibility Criteria

This trial is for adults with untreated indolent non-Hodgkin's lymphoma, including various types of marginal zone and follicular lymphomas. Participants must have measurable disease, be able to swallow pills, and not have severe liver failure or other serious health conditions. Women of childbearing potential need a negative pregnancy test and agree to use effective contraception.

Inclusion Criteria

I have symptoms or conditions due to my lymphoma that require treatment.
I have a type of slow-growing non-Hodgkin's lymphoma known as follicular lymphoma.
My MZL cancer requires systemic therapy and has been confirmed with a biopsy.
See 28 more

Exclusion Criteria

I do not have active hepatitis B.
Patient is receiving other investigational drugs
I haven't had a major infection or been on IV antibiotics in the last 4 weeks.
See 23 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ibrutinib orally once daily and obinutuzumab intravenously on specified days, repeating every 28 days for up to 6 cycles

6 months
Multiple visits per cycle for IV administration

Maintenance

Participants with stable disease continue to receive obinutuzumab every 2 months for a total of 12 doses

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

7 years
Monthly for 1 year, every 3-6 months for 4 years, then annually

Treatment Details

Interventions

  • Ibrutinib
  • Obinutuzumab
Trial Overview The study tests the combination of obinutuzumab (a monoclonal antibody) and ibrutinib (an enzyme blocker) as initial treatment for patients with certain types of slow-growing non-Hodgkin's lymphoma. The goal is to see if this drug combo can stop cancer cells from growing by interfering with their function.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (ibrutinib, obinutuzumab)Experimental Treatment3 Interventions
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab intravenously (IV) on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2 months after cycle 6, patients with stable disease will continue to receive obinutuzumab every 2 months for a total of 12 doses. After completion of study treatment, patients are followed up monthly for 1 year, every 3-6 months for 4 years, and then annually for up to 2 years.

Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Imbruvica for:
  • Chronic lymphocytic leukemia
  • Mantle cell lymphoma
  • Waldenström's macroglobulinemia
  • Marginal zone lymphoma
  • Graft-versus-host disease
🇺🇸
Approved in United States as Imbruvica for:
  • Chronic lymphocytic leukemia/small lymphocytic lymphoma
  • Mantle cell lymphoma
  • Waldenström's macroglobulinemia
  • Marginal zone lymphoma
  • Graft-versus-host disease
🇨🇦
Approved in Canada as Imbruvica for:
  • Chronic lymphocytic leukemia
  • Mantle cell lymphoma
  • Waldenström's macroglobulinemia
  • Marginal zone lymphoma
🇯🇵
Approved in Japan as Imbruvica for:
  • Chronic lymphocytic leukemia
  • Mantle cell lymphoma
  • Waldenström's macroglobulinemia

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sidney Kimmel Cancer Center at Thomas Jefferson University

Lead Sponsor

Trials
164
Recruited
10,900+

Genentech, Inc.

Industry Sponsor

Trials
1,578
Recruited
569,000+
Ashley Magargee profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Pharmacyclics LLC.

Industry Sponsor

Trials
114
Recruited
13,800+

Dr. Maky Zanganeh

Pharmacyclics LLC.

Chief Executive Officer

Degree from Louis Pasteur University in Strasbourg, France; MBA from Schiller International University in France

Dr. Ellie Im

Pharmacyclics LLC.

Chief Medical Officer

MD from an unspecified institution

Findings from Research

In a phase II study involving 50 previously untreated patients with indolent mantle cell lymphoma (MCL), the combination of ibrutinib and rituximab resulted in an impressive 80% complete response rate after 12 treatment cycles.
The treatment also led to undetectable minimal residual disease (MRD) in 87% of patients, allowing 69% of evaluable patients to safely discontinue ibrutinib after 2 years, although caution is advised for those with TP53 mutations.
Ibrutinib in Combination With Rituximab for Indolent Clinical Forms of Mantle Cell Lymphoma (IMCL-2015): A Multicenter, Open-Label, Single-Arm, Phase II Trial.Giné, E., de la Cruz, F., Jiménez Ubieto, A., et al.[2022]
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]
Obinutuzumab (Gazyva) is an effective treatment for chronic lymphocytic leukemia, targeting specific cancer cells to improve patient outcomes.
Ibrutinib (Imbruvica) is used for mantle-cell lymphoma and works by inhibiting a protein that helps cancer cells survive, while sofosbuvir (Sovaldi) effectively treats chronic hepatitis C by blocking the virus's ability to replicate.
Pharmaceutical approval update.Goldenberg, MM.[2021]

References

Ibrutinib in Combination With Rituximab for Indolent Clinical Forms of Mantle Cell Lymphoma (IMCL-2015): A Multicenter, Open-Label, Single-Arm, Phase II Trial. [2022]
Battle of Thermopylae: 300 Spartans (natural killer cells plus obinutuzumab) versus the immortal warriors (chronic lymphocytic leukemia cells) of Xerxes' army. [2022]
Pharmaceutical approval update. [2021]
Ibrutinib (imbruvica): a novel targeted therapy for chronic lymphocytic leukemia. [2021]
The combination of ibrutinib and rituximab demonstrates activity in first-line follicular lymphoma. [2021]
Obinutuzumab: A Review in Rituximab-Refractory or -Relapsed Follicular Lymphoma. [2018]
Obinutuzumab (GA101) plus CHOP or FC in relapsed/refractory follicular lymphoma: results of the GAUDI study (BO21000). [2022]
Safety and activity of ibrutinib in combination with nivolumab in patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukaemia: a phase 1/2a study. [2021]
Obinutuzumab plus bendamustine versus bendamustine monotherapy in patients with rituximab-refractory indolent non-Hodgkin lymphoma (GADOLIN): a randomised, controlled, open-label, multicentre, phase 3 trial. [2022]
Obinutuzumab for the treatment of indolent lymphoma. [2018]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security