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Monoclonal Antibodies
Atezolizumab + Chemo-Immunotherapy for Diffuse Large B-Cell Lymphoma
Phase 1
Waitlist Available
Led By Alex F Herrera
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a combination of immunotherapy and chemotherapy drugs to treat patients with a certain type of lymphoma that has returned or does not respond to treatment.
Who is the study for?
Adults over 18 with relapsed or refractory transformed diffuse large B-cell lymphoma, including those who have had it change from a less aggressive form or Richter transformation. Participants need to have previously tried at least one treatment and should not be severely ill (ECOG <=2). They must not be pregnant, agree to use contraception, and cannot have certain health conditions like severe allergies, recent infections, or organ transplants.
What is being tested?
The trial is testing the combination of Atezolizumab (an immunotherapy drug) with standard chemo-immunotherapy drugs Rituximab, Gemcitabine, and Oxaliplatin in patients whose lymphoma has returned or hasn't responded to treatment. It aims to see if this mix can better help the immune system fight cancer by stopping tumor growth and spread.
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal organs (like inflammation), infusion-related reactions from receiving drugs through a vein, fatigue, digestive issues such as nausea and diarrhea, blood disorders like low counts of different types of cells that could increase infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events
Maximum tolerated dose (MTD) and recommended phase 2 dose
Secondary study objectives
Best overall response rate (complete response + partial response)
Biomarker analysis
Complete response rate
Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
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
9%
Neutrophil count decreased
9%
Rash
8%
Headache
8%
Dysgeusia
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Febrile neutropenia
6%
Pneumonia
6%
Lacrimation increased
6%
Abdominal pain
6%
Dry skin
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Awards & Highlights
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: Treatment (rituximab, gemcitabine, oxaliplatin, atezolizumab)Experimental Treatment10 Interventions
INDUCTION PHASE: Patients receive rituximab IV, gemcitabine IV, and oxaliplatin IV every 2 weeks. Starting cycle 2, patients also receive atezolizumab IV over 30-60 minutes every 2 weeks. Treatment repeats every 14 days of cycle 1 and every 28 days for up to 4 cycles in the absence of disease progression or unaccepted toxicity. Patients also undergo CT, PET-CT, MRI, bone marrow biopsy, collection of blood samples, and tumor biopsy throughout induction phase.
MAINTENANCE PHASE: Patients receive rituximab IV and atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unaccepted toxicity. Patients also undergo CT, PET-CT, MRI, bone marrow biopsy, and collection of blood samples throughout maintenance phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2030
Biopsy
2014
Completed Phase 4
~1150
Oxaliplatin
2011
Completed Phase 4
~2890
Atezolizumab
2016
Completed Phase 3
~5860
Rituximab
1999
Completed Phase 4
~2990
Bone Marrow Biopsy
2021
Completed Phase 3
~230
Computed Tomography
2017
Completed Phase 2
~2790
Gemcitabine
2017
Completed Phase 3
~1920
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Positron Emission Tomography
2011
Completed Phase 2
~2200
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,018,115 Total Patients Enrolled
Alex F HerreraPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO
11 Previous Clinical Trials
1,537 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.My lymphoma has changed into a more aggressive type known as DLBCL.I have a significant liver condition.My white blood cell count is healthy, unless my bone marrow is affected by lymphoma.You should have a platelet count of at least 75,000/mcL, unless you have lymphoma that has spread to your bone marrow.My hemoglobin level is at least 8 g/dL or my low level is due to lymphoma in my bone marrow.I can take care of myself but might not be able to do active work.I am HIV-positive, on stable HAART, with no current infections needing antibiotics or antifungals, a CD4 count over 250, and an undetectable viral load.I have had a bone marrow or solid organ transplant in the past.I have been treated with drugs targeting PD-1 or PD-L1.My lymphoma has spread to my brain or spinal cord.I have not received a live vaccine in the last 4 weeks and do not plan to during or up to 5 months after the study.I haven't taken any immune-boosting drugs in the last 6 weeks.I have not met the specific requirements for anti-CTLA-4 treatment.I haven't taken any immune-weakening drugs in the last 2 weeks.I haven't had major surgery in the last 28 days and don't expect to need one during the study.My condition worsened or didn't respond after my first treatment.I haven't had chemotherapy or radiotherapy in the last 2 weeks, or 6 weeks for specific drugs, and have recovered from any side effects.I haven't taken any experimental drugs in the last 3 weeks.I am on bisphosphonates for high calcium or need RANKL inhibitor treatment.I have or am at risk for an autoimmune disease.I have not had signs of infection in the last 2 weeks.I do not have any unmanaged ongoing illnesses.I have not taken any antibiotics by mouth or IV in the last 2 weeks.My lymphoma has changed into a more aggressive form known as DLBCL.I have a tumor that is larger than 1.5 cm, confirmed by a scan.I am 18 years old or older.My kidneys are working well enough to clear waste.I have been treated with gemcitabine and oxaliplatin before.I have a history of lung scarring or inflammation.I have active tuberculosis.I have not had severe infections in the last 4 weeks.I am not pregnant or breastfeeding.I have a tumor that is larger than 1.5 cm, confirmed by a scan.Your white blood cell count is at least 2,500 cells per microliter, unless your bone marrow is affected by lymphoma.My doctor expects me to live more than 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (rituximab, gemcitabine, oxaliplatin, atezolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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