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Monoclonal Antibodies

Triple Therapy for Chronic Lymphocytic Leukemia

Phase 2

Recruiting

Led By Nitin Jain

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Age must be greater than or equal to 18 years

Patients will have a diagnosis of CLL or SLL or RT and meet specific criteria for treatment-naïve CLL/SLL or RT

Must not have

Prior treatment with certain medications

Recent major surgeries or therapies within 4 weeks prior to the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is studying how well atezolizumab, obinutuzumab, and venetoclax work in treating patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, or Richter syndrome that has come back or does not respond to treatment.

Who is the study for?

Adults over 18 with chronic lymphocytic leukemia, small lymphocytic lymphoma, or Richter syndrome that's untreated or resistant to treatment. They must be in good physical condition (ECOG ≤2), have normal liver and kidney function, not be pregnant or breastfeeding, agree to use effective contraception, and have no major health issues like uncontrolled hypertension or recent strokes.

What is being tested?

The trial is testing a combination of atezolizumab (an immune system booster) with obinutuzumab and venetoclax (chemotherapy drugs). It aims to see if this mix can better stop the growth of cancer cells in patients with certain blood cancers compared to current treatments.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation in organs, infusion-related reactions; chemotherapy-associated risks like nausea, fatigue; potential for increased risk of infections due to weakened immunity; and possibly abnormal blood test results.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have been diagnosed with CLL, SLL, or RT and have not received any treatment.

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I can take care of myself and am up and about more than half of my waking hours.

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My kidney and liver are working well.

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I am not pregnant and agree to use birth control.

Exclusion Criteria

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

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I have taken specific medications before.

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I haven't had major surgery or therapy in the last 4 weeks.

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I have not received any live vaccines recently.

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I have severe ongoing health or mental health issues.

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I still have side effects from previous cancer treatments.

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I have serious heart-related conditions.

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My blood pressure is not controlled by medication.

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My CLL has spread to my brain or its coverings.

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I have received an organ transplant from another person.

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I do not have any untreated or uncontrolled infections.

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I have a history of lung conditions.

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I have hepatitis B, C, or HIV.

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I have taken strong CYP3A inhibitors or inducers.

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I am currently taking high-dose steroids or medications that suppress my immune system.

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I have a serious liver condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Minimal residual disease (MRD) negative rate (Cohort I)

Secondary study objectives

Best overall response

Complete response rate

Duration of response

+3 more

Other study objectives

Change in immunological and molecular features

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Dysgeusia

Headache

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

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.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort II (obinutuzumab, atezolizumab, venetoclax)Experimental Treatment4 Interventions

Patients receive obinutuzumab intravenously IV over 4-6 hours on days 1, 2, 8, and 15 of cycle 1 and on day 1 of cycles 2-9 and atezolizumab IV over 30-60 minutes on days 3-4 of cycle 1 and on days 1-2 of cycles 2-9. Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 2, patients receive venetoclax PO on days 1-28. Treatment repeats every 28 days for 25 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Cohort I (obinutuzumab, atezolizumab, venetoclax)Experimental Treatment4 Interventions

Patients receive obinutuzumab IV over 4-6 hours on days 1, 2, 8, and 15 of cycle 1 and on day 1 of cycles 2-9 and atezolizumab IV over 30-60 minutes on days 3-4 of cycle 1 and on days 1-2 of cycles 2-9. Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 3, patients also receive venetoclax PO on days 1-28. Treatment repeats every 28 days for 14 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

FDA approved

Atezolizumab

FDA approved

Obinutuzumab

FDA approved

0 / 20Eligibility criteria met