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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Minimal residual disease (MRD) negative rate (Cohort I)
Secondary outcome measures
Best overall response
Complete response rate
Duration of response
+3 more
Other outcome measures
Change in immunological and molecular features

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
27%
Fatigue
25%
Decreased appetite
24%
Cough
19%
Dyspnoea
19%
Asthenia
18%
Constipation
18%
Pyrexia
18%
Nausea
16%
Diarrhoea
13%
Arthralgia
12%
Vomiting
12%
Anaemia
11%
Back pain
11%
Musculoskeletal pain
11%
Rash
10%
Headache
9%
Oedema peripheral
9%
Weight decreased
9%
Chest pain
9%
Insomnia
9%
Pruritus
9%
Pain in extremity
8%
Dizziness
7%
Upper respiratory tract infection
7%
Aspartate aminotransferase increased
7%
Myalgia
7%
Haemoptysis
6%
Influenza like illness
6%
Nasopharyngitis
6%
Alanine aminotransferase increased
6%
Bronchitis
6%
Productive cough
5%
Musculoskeletal chest pain
5%
Depression
5%
Dry skin
4%
Abdominal pain
4%
Urinary tract infection
4%
Neuropathy peripheral
4%
Paraesthesia
3%
Stomatitis
3%
Dysgeusia
3%
Pneumonia
2%
Malaise
2%
Pleural effusion
2%
Neutropenia
1%
Lacrimation increased
1%
Respiratory tract infection
1%
Sepsis
1%
Pneumonitis
1%
Mucosal inflammation
1%
Bone pain
1%
Pulmonary embolism
1%
Peripheral sensory neuropathy
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab
Docetaxel

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

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,300 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,276 Total Patients Enrolled
Nitin JainPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
524 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02846623 — Phase 2
Chronic Lymphocytic Leukemia Research Study Groups: Cohort II (obinutuzumab, atezolizumab, venetoclax), Cohort I (obinutuzumab, atezolizumab, venetoclax)
Chronic Lymphocytic Leukemia Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT02846623 — Phase 2
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02846623 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being accepted for this medical experiment?

"Affirmative, according to clinicaltrials.gov this research is currently enrolling participants. It was first listed on January 31st 2017 and recently updated on August 23rd 2022 with the aim of recruiting 65 people from a single site."

Answered by AI

What therapeutic purposes is Atezolizumab typically employed for?

"Atezolizumab is routinely used to treat chronic lymphocytic leukemia (CLL) as well as pharmacotherapy, small cell lung cancer (SCLC), and malignant neoplasms."

Answered by AI

Is this an unprecedented or untested clinical trial?

"Atezolizumab has been in circulation since 2008, when it was initially developed and sponsored by Hoffmann-La Roche. Following the Phase 1 trial involving 720 participants, Atezolizumab went on to receive its drug approval for Phase 2 trials. Presently there are 627 active clinical studies being conducted across 2090 cities and 75 countries concerning this medication's efficacy."

Answered by AI

Has Atezolizumab attained regulatory endorsement from the FDA?

"The safety of Atezolizumab was assigned a rating of 2, as evidence from Phase 2 clinical trials supports its security but there is still no data to verify its efficacy."

Answered by AI

Have any other investigations been conducted with Atezolizumab?

"Presently, 627 trials are underway for Atezolizumab. Out of those studies, 105 have completed Phase 3 and entered real-world testing. Initially based in Edmonton, Alberta, 26910 locations are now running clinical tests on this medication."

Answered by AI

Is recruitment for this experiment still ongoing?

"Affirmative. The clinical trial is actively recruiting participants, as evidenced on the listings found on clincialtrials.gov. Initially posted in January of 2017 and revised August 23rd 2022, this research effort seeks 65 patients from one site for participation."

Answered by AI
~7 spots leftby Feb 2025