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Monoclonal Antibodies
Guadecitabine + Atezolizumab for Chronic Myelomonocytic Leukemia
Phase 1 & 2
Waitlist Available
Led By Casey O'Connell
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
Adult subjects with advanced MDS requiring therapy who were previously treated with either azacitidine or decitabine for at least 4 cycles and deemed to have failed therapy due to progression of disease using International Working Group (IWG) criteria ('refractory') or losing their previously documented response to the therapy ('relapsed')
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of guadecitabine when given with atezolizumab to see if the combination can effectively treat patients with myelodysplastic syndrome or chronic myelomonocytic leukemia.
Who is the study for?
This trial is for adults with advanced Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) that has returned or isn't responding to treatment. Participants must have tried specific drugs before, be able to follow the study plan, and not be pregnant or fathering a child. They should also meet certain health criteria like normal organ function tests.Check my eligibility
What is being tested?
The trial is testing how well guadecitabine works with atezolizumab in treating MDS/CMML. Guadecitabine may block enzymes needed for cancer cell growth, while atezolizumab, an antibody, might stop cancer cells from growing and spreading.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting organs, infusion-related reactions such as fever or chills, fatigue, digestive issues like nausea or diarrhea, blood disorders including low counts of various types of cells which can increase infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to not have unprotected sex or donate sperm.
Select...
I have advanced MDS, was treated with azacitidine or decitabine, and my condition worsened or didn't improve.
Select...
My MDS is classified as Intermediate 1-risk or higher.
Select...
My condition is classified as CMML.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose-limiting toxicities evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
Overall response (complete response [CR] + partial response + marrow CR + hematological improvement) (Phase II)
Secondary outcome measures
Incidence of grade 3 or higher adverse events and grade 2 toxicities that do not resolve after 3 weeks assessed by CTCAE 4.0
Overall response rate (Phase II)
Overall survival
+3 moreOther outcome measures
Degree of PD-L1 expression assessed in bone marrow, T cells, and malignant cells by immunohistochemistry or flow cytometry
PD-1 expression by T cells and malignant cells
Percentage of T cells expressing PD-1/methylation levels
+3 moreSide effects data
From 2020 Phase 3 trial • 417 Patients • NCT0290735934%
Neutropenia
31%
Thrombocytopenia
30%
Febrile Neutropenia
27%
Pneumonia
23%
Anaemia
23%
Constipation
22%
Diarrhoea
22%
Fatigue
22%
Pyrexia
20%
Asthenia
18%
Decreased Appetite
17%
Injection Site Reaction
17%
Hypokalaemia
16%
Epistaxis
16%
Nausea
16%
Oedema Peripheral
14%
Stomatitis
14%
Cough
13%
Dizziness
13%
Headache
12%
Back Pain
12%
Leukopenia
12%
Dyspnoea
11%
Insomnia
11%
Vomiting
10%
Rash
10%
Sepsis
10%
Abdominal Pain
9%
Petechiae
9%
Contusion
8%
Weight Decreased
8%
Cellulitis
7%
Arthralgia
7%
Pruritus
6%
Fall
6%
Musculoskeletal Pain
6%
Septic Shock
6%
Upper Respiratory Tract Infection
6%
Transfusion Reaction
6%
Pain In Extremity
6%
Haematoma
6%
Haemorrhoids
6%
Hypotension
5%
Urinary Tract Infection
5%
Blood Creatinine Increased
5%
Hypomagnesaemia
5%
Oropharyngeal Pain
5%
Erythema
5%
Oedema
5%
Alanine Aminotransferase Increased
4%
Nasopharyngitis
4%
Aspartate Aminotransferase Increased
4%
Bacteraemia
2%
Atrial Fibrillation
1%
Cardiac Failure Congestive
1%
Acute Myocardial Infarction
1%
Tumour Lysis Syndrome
1%
Pulmonary Embolism
1%
Cholangitis
1%
Subcutaneous Abscess
1%
General Physical Health Deterioration
1%
Angina Pectoris
1%
Colitis
1%
Anal Abscess
1%
Device Related Infection
1%
Cardiac Failure
1%
Gastrointestinal Haemorrhage
1%
Lower Gastrointestinal Haemorrhage
1%
Multiple Organ Dysfunction Syndrome
1%
Bronchopulmonary Aspergillosis
1%
Infection
1%
Urosepsis
1%
Bronchitis
1%
Cellulitis Orbital
1%
Chronic Sinusitis
1%
Corynebacterium Infection
1%
Pseudomonal Bacteraemia
1%
Sinusitis
1%
Staphylococcal Bacteraemia
1%
Subarachnoid Haemorrhage
1%
Haematuria
1%
Respiratory Tract Infection
1%
Haemorrhage Intracranial
1%
Prostatitis
1%
Febrile Bone Marrow Aplasia
1%
Leukocytosis
1%
Leukostasis Syndrome
1%
Pancytopenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Guadecitabine
Treatment Choice
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (guadecitabine, atezolizumab)Experimental Treatment2 Interventions
Patients receive guadecitabine SC on days 1-5 and atezolizumab IV over 30-60 minutes on days 8 and 22. Courses repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Guadecitabine
Not yet FDA approved
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
905 Previous Clinical Trials
1,596,285 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,120 Total Patients Enrolled
Van Andel Research InstituteOTHER
27 Previous Clinical Trials
5,364 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I haven't had a serious infection needing strong medicine or a hospital stay in the last 28 days.I agree to not have unprotected sex or donate sperm.I have an autoimmune disease, but it's not vitiligo, type 1 diabetes, or hypothyroidism needing hormone therapy.I have a history of lung scarring or inflammation not caused by infections.I have AML with more than 30% blasts in my bone marrow or WBC over 25 x 10^3/L.I am currently pregnant or breastfeeding.I haven't had a fever for at least 72 hours and have finished any antibiotics.I have hepatitis B, C, or HIV and am on stable antiviral treatment.I am taking preventive antibiotics or antivirals due to low white blood cell counts without a current infection.I haven't taken steroids or immunosuppressants in the last 14 days.I have advanced MDS, was treated with azacitidine or decitabine, and my condition worsened or didn't improve.My condition is classified as CMML.I've had a bone marrow test in the last 8 weeks to check for cancer cells.My MDS is classified as Intermediate 1-risk or higher.I agree to use highly effective birth control during and 90 days after treatment.I am expected to live more than 3 months despite my other health conditions.I haven't taken drugs that strongly affect the immune system or had severe allergies to specific medications.I do not have a history of lung disease that requires me to use oxygen all the time.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (guadecitabine, 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this clinical experiment been attempted before?
"To date, 357 live trials for Guadecitabine have been conducted across 74 countries and 1646 cities. Starting in 2008, when Hoffmann-La Roche conducted a Phase 2 study with 720 patients to gain approval, 94 studies have since taken place."
Answered by AI
Are there opportunities for potential participants to join this endeavor?
"The information hosted on clinicaltrials.gov suggests that this medical trial is no longer looking for study participants, as its most recent update was posted on August 5th 2022. However, there are still 3 067 other active trials requiring patient recruitment at the moment."
Answered by AI
What is the current enrollment capacity of this experiment?
"This clinical trial has closed its participant recruitment as of August 5th 2022. It had first been posted on November 2nd 2016. Other studies with muscular dystrophy actively seeking enrolment include 2710 trials, while 357 are available for Guadecitabine patients."
Answered by AI
Please explain the extant research done on Guadecitabine and its efficacy.
"First tested in 2008 at SCRI Tennessee Oncology Chattanooga, guadecitabine has since been the subject of 94 completed investigations. An additional 357 trials are currently underway, many based out of Baltimore's medical centres."
Answered by AI
What medical indications is Guadecitabine typically employed for?
"Guadecitabine is a common therapy for small cell lung cancer, and it also has the potential to help manage post-operative malignant neoplasms as well as non-small cell lung carcinoma."
Answered by AI
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