What side effects are associated with this type of intervention?

Common treatments for Chronic Lymphocytic Leukemia (CLL) include monoclonal antibodies like obinutuzumab, Bruton tyrosine kinase (BTK) inhibitors such as ibrutinib, and BCL-2 inhibitors like venetoclax. Obinutuzumab can cause side effects such as neutropenia, febrile neutropenia, and infusion-related reactions. Ibrutinib is associated with diarrhea, peripheral edema, dry eye, arthralgia, hypertension, atrial fibrillation, and increased risk of infections. Venetoclax can lead to neutropenia, tumor lysis syndrome, and gastrointestinal issues. Chemoimmunotherapy regimens, which may include agents like fludarabine and cyclophosphamide, can cause myelosuppression, increased infection risk, and autoimmune cytopenias.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Lymphocytic Leukemia (CLL) that are similar to Obinutuzumab, a monoclonal antibody targeting CD20. These include Rituximab and Ofatumumab, which are also anti-CD20 monoclonal antibodies. Rituximab has been used in combination with chemotherapeutic agents like fludarabine and cyclophosphamide (FCR regimen) and bendamustine (BR regimen). Ofatumumab has been approved for use in combination with chlorambucil. Additionally, Obinutuzumab itself has been approved in combination with chlorambucil and venetoclax for the treatment of CLL. These therapies aim to improve progression-free survival and overall response rates in patients with CLL.

What other types of research exist?

Promising alternatives to GA101 (Obinutuzumab) for CLL treatment in 2024 include: 1) BTK inhibitors such as ibrutinib, acalabrutinib, and zanubrutinib, which are effective and have varying tolerability profiles. 2) Venetoclax, particularly in combination with obinutuzumab, which has shown high rates of undetectable MRD and improved PFS. 3) Combinations of BTK inhibitors with other agents, such as ibrutinib plus venetoclax, which are being actively studied for their potential synergistic effects.

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Corticosteroid

Obinutuzumab + HDMP for Chronic Lymphocytic Leukemia (GA101 & HDMP Trial)

Q: What is the mechanism of action of this treatment?

The most common treatments for Chronic Lymphocytic Leukemia (CLL) include monoclonal antibodies like obinutuzumab, BTK inhibitors, and BCL-2 inhibitors. Obinutuzumab targets the CD20 protein on the surface of B-cells, leading to their destruction through immune-mediated mechanisms. This is crucial for CLL patients as it directly reduces the number of malignant B-cells. BTK inhibitors, such as ibrutinib, block Bruton's tyrosine kinase, a key enzyme in B-cell receptor signaling, thereby inhibiting the growth and survival of CLL cells. BCL-2 inhibitors, like venetoclax, promote apoptosis in CLL cells by inhibiting the BCL-2 protein, which normally helps these cells evade programmed cell death. These mechanisms are vital for CLL patients as they target the disease at different biological levels, offering multiple avenues to control and potentially eradicate the cancerous cells.

Phase 1 & 2

Waitlist Available

Led By Kipps Thomas, MD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hepatic parameters: Total Bilirubin < 3 x ULN, ALT and AST < 3 x ULN

Diagnosis of CLL

Must not have

Active Hepatitis B or C

Cardiac disease grade 3 or 4

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a new drug combination for CLL patients, using Obinutuzumab and high-dose methylprednisone. It includes patients who are new to treatment and those who haven't responded to other treatments. The goal is to see if this combination can effectively target and destroy cancer cells while reducing inflammation. Obinutuzumab is a fully humanized antibody that targets specific cells and has been approved for use with other treatments in patients with previously untreated CLL.

Who is the study for?

This trial is for adults with Chronic Lymphocytic Leukemia who have a life expectancy of at least 6 months, can perform daily activities (ECOG <2), and have adequate kidney, liver, and blood function. It's open to those new to treatment or with previous treatments but not to pregnant women or those on recent other cancer therapies.

What is being tested?

The study tests Obinutuzumab combined with high-dose Methylprednisolone in CLL patients. The hypothesis suggests this combination could be more effective than previous similar treatments. Participants will receive these drugs and their responses will be monitored.

What are the potential side effects?

Potential side effects may include allergic reactions to the monoclonal antibody therapy, infusion-related reactions from the drug administration, as well as impacts on organ functions due to both medications involved.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver function tests are within normal limits.

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I have been diagnosed with chronic lymphocytic leukemia (CLL).

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I can do most of my daily activities without help.

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My kidneys are functioning well enough (creatinine clearance over 30 mL/min).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active Hepatitis B or C.

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I have severe heart disease.

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I do not have any active infections.

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I have had another type of cancer in the past.

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I have not received a live vaccine recently.

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I have a severe lung condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: GA101/HDMPExperimental Treatment1 Intervention

All subjects will receive GA101 - Obinutuzumab by IV infusion for up to 6 cycles (28-day cycles) as follow: * On Cycle 1, Day 1, 100 mg GA101-obinutuzumab will be administered. * On Cycle 1, Day 2, 900 mg of GA101-obinutuzumab will be administered. * On Cycle 1, Days 8 and 15, 1,000 mg of GA101-obinutuzumab will be administered. * On Cycles 2-6, Day 1, 1,000 mg of GA101-obinutuzumab will be administered. All subjects will receive HDMP by IV infusion for up to 4 cycles (28-day cycles) as follow: •On Cycle 1-4, Days 1 to 3, 1,000 mg/m2 Methylprednisolone will be administered.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chronic Lymphocytic Leukemia (CLL) include monoclonal antibodies like obinutuzumab, BTK inhibitors, and BCL-2 inhibitors. Obinutuzumab targets the CD20 protein on the surface of B-cells, leading to their destruction through immune-mediated mechanisms. This is crucial for CLL patients as it directly reduces the number of malignant B-cells. BTK inhibitors, such as ibrutinib, block Bruton's tyrosine kinase, a key enzyme in B-cell receptor signaling, thereby inhibiting the growth and survival of CLL cells. BCL-2 inhibitors, like venetoclax, promote apoptosis in CLL cells by inhibiting the BCL-2 protein, which normally helps these cells evade programmed cell death. These mechanisms are vital for CLL patients as they target the disease at different biological levels, offering multiple avenues to control and potentially eradicate the cancerous cells.

Obinutuzumab Plus Chlorambucil in a Patient with Severe Myasthenia Gravis and Chronic Lymphocytic Leukemia.