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Anti-tumor antibiotic

Nivolumab + Chemotherapy for Acute Myeloid Leukemia

Phase 1
Waitlist Available
Led By Alice S Mims
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
Risks from venetoclax and nivolumab to the developing human fetus cannot be ruled out. For this reason and because decitabine is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Contraception use should be continued 6 months after the completion of all study treatments for women of child bearing potential. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 7 months after completion of decitabine, venetoclax, or nivolumab administration
White blood count (WBC) must be =< 25,000 at time of day 1 of study treatment. Cytoreduction with Hydrea and leukapheresis is allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing the side effects of combining immunotherapy with two different types of chemotherapy to treat patients with a specific type of leukemia.

Who is the study for?
This trial is for adults with newly diagnosed, untreated acute myeloid leukemia (AML) that has a TP53 mutation. Participants must have good organ function, controlled infection if present, no severe concurrent illness or psychiatric conditions, and agree to use contraception. Prior hypomethylating therapy for MDS is allowed.Check my eligibility
What is being tested?
The study tests the effectiveness and side effects of combining nivolumab (an immunotherapy drug), decitabine, and venetoclax in treating AML with TP53 mutations. It aims to see if this combination works better than standard treatments.See study design
What are the potential side effects?
Potential side effects include immune-related reactions due to nivolumab affecting healthy cells while targeting cancer cells; decitabine and venetoclax may cause fatigue, nausea, low blood cell counts increasing infection risk, bleeding or bruising.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use effective birth control during and after the study.
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My white blood cell count is less than or equal to 25,000.
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I have been diagnosed with acute myeloid leukemia through tissue or cell analysis.
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My kidney function, measured by GFR, is above 40 mL/min.
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I have been recently diagnosed with AML and have not received any treatment.
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I can take care of myself but might not be able to do heavy physical work.
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My cancer was diagnosed with a TP53 mutation.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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My hepatitis B is under control with treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Number of patients that are able to complete 3 cycles of therapy
Response
Secondary outcome measures
Anti-tumor activity
Deoxyribonucleic acid (DNA) methylation
Minimal residual disease (MRD)
+3 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
Pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Hypercalcaemia
1%
Pericardial effusion malignant
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (nivolumab, decitabine, venetoclax)Experimental Treatment3 Interventions
INDUCTION: Patients receive nivolumab IV over 30 minutes on day 15 of cycle 1 and days 1 and 15 of subsequent cycles, decitabine IV over 60 minutes on days 1-10 of induction cycle 1 (and cycles 2 and 3 if needed), and venetoclax PO QD on days 1-21. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients who achieve a CR or CRi receive nivolumab IV over 30 minutes on days 1 and 15, decitabine IV over 60 minutes on days 1-5, and venetoclax PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decitabine
2004
Completed Phase 3
~1680
Nivolumab
2014
Completed Phase 3
~4750
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,654 Total Patients Enrolled
Alice S MimsPrincipal InvestigatorOhio State University Comprehensive Cancer Center LAO
1 Previous Clinical Trials
28 Total Patients Enrolled

Media Library

Decitabine (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04277442 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Treatment (nivolumab, decitabine, venetoclax)
Acute Myeloid Leukemia Clinical Trial 2023: Decitabine Highlights & Side Effects. Trial Name: NCT04277442 — Phase 1
Decitabine (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04277442 — Phase 1

Frequently Asked Questions

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

Does Nivolumab have FDA approval for general use?

"Nivolumab's safety is only supported by a limited amount of data, so it received a score of 1."

Answered by AI

What are the conditions that Nivolumab is known to improve?

"Nivolumab is an immunotherapy treatment that can be used to target unresectable melanoma, squamous cell carcinoma, and high risk of recurrence."

Answered by AI

Can you elaborate on Nivolumab's role in other medical research?

"There are presently 1058 studies being conducted that involve Nivolumab. Out of those, 125 are clinical trials that are in their third phase. The majority of the trials take place in Edmonton, Alberta; however, there are 48610 locations running trials for this treatment."

Answered by AI

How many participants are being allowed to take part in this clinical trial?

"Recruitment for this study has closed. The listing was first created on February 6th, 2020 but was updated as recently as August 19th, 2022. There are currently 1587 other trials actively enrolling patients with leukemia, myelocytic, acute and 1058 for Nivolumab."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing Nivolumab in Combination With Decitabine and Venetoclax in Patients With Newly Diagnosed TP53 Gene Mutated Acute Myeloid Leukemia
2020. "Testing Nivolumab in Combination With Decitabine and Venetoclax in Patients With Newly Diagnosed TP53 Gene Mutated Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04277442.
~2 spots leftby Feb 2025
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