Your session is about to expire
← Back to Search
Anti-metabolites
Nivolumab for Biphenotypic Leukemia
Phase 2
Waitlist Available
Led By Naval Daver
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing nivolumab, azacitidine, and ipilimumab to treat patients with AML that has not responded to previous treatment or has returned after a period of improvement.
Eligible Conditions
- Biphenotypic Leukemia
- Chronic Myelomonocytic Leukemia
- Acute Myeloid Leukemia
- Myelodysplastic Syndrome
- Acute Myelogenous Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy as measured by the overall response rate defined as complete response + complete response with incomplete platelet recovery + complete response with incomplete count recovery + partial response + marrow clearance of blasts (Phase II)
Incidence of adverse events graded according to CTCAE
Maximum tolerated dose of nivolumab with dihydro-5-azacytidine, based on the incidence of dose limiting toxicity assessed by the Common Terminology Criteria for Adverse Events (CTCAE) (Lead-in phase)
Secondary outcome measures
Disease-free survival
Overall survival
Progression-free survival
Other outcome measures
Immunological changes in peripheral blood and bone marrow
Induction of hypomethylation and deoxyribonucleic acid damage during therapy
Bone Marrow
Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
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%
Dehydration
7%
Hyperglycaemia
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%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
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%
Small intestinal haemorrhage
1%
Confusional state
1%
Pneumothorax
1%
Atrial flutter
1%
Femur fracture
1%
Bone pain
1%
Cancer pain
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Hypercalcaemia
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
2Treatment groups
Experimental Treatment
Group I: Arm II (azacitidine, nivolumab, ipilimumab)Experimental Treatment4 Interventions
Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (azacitidine, nivolumab)Experimental Treatment3 Interventions
Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses 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
Nivolumab
2014
Completed Phase 3
~4750
Azacitidine
2012
Completed Phase 3
~1440
Ipilimumab
2014
Completed Phase 3
~2620
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,067 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,340 Total Patients Enrolled
1 Trials studying Biphenotypic Leukemia
44 Patients Enrolled for Biphenotypic Leukemia
Naval DaverPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
180 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have leukemia that has spread to your central nervous system (brain and spinal cord) and is causing symptoms.You are using reliable birth control methods like the pill, injection, or implant to prevent pregnancy.You have a history of certain autoimmune diseases, which are conditions where the body's immune system attacks itself.You have both of the following conditions at the same time.You have a history of certain autoimmune diseases like rheumatoid arthritis, scleroderma, lupus, or vasculitis.If you have Acute Myeloid Leukemia (AML) and have tried one prior treatment without success, you can participate in Arm 2 of the study. However, if you had a stem cell transplant while in remission, it will not be considered as a prior treatment. Additionally, if you only used hydroxyurea by itself, it will also not be considered as a prior treatment.You are allowed to have received previous treatment with certain medications like hydroxyurea, chemotherapy, targeted therapy, or growth factors for blood-related conditions.You have a history of inflammatory bowel disease, which includes conditions like Crohn's disease and ulcerative colitis.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (azacitidine, nivolumab)
- Group 2: Arm II (azacitidine, nivolumab, ipilimumab)
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.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger