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Hypomethylating Agent
Oral Azacitidine + Durvalumab for Myelodysplastic Syndrome
Phase 2
Waitlist Available
Research Sponsored by Celgene
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 response was assessed every 2 cycles following treatment during the first 6 cycles, then every 3 cycles thereafter; median duration of treatment = 5.26 and 3.81 months for sd/pd for oral aza arms respectively, and 1.84 months for aza and durva sd/pd arms
Awards & highlights
Study Summary
This trial is evaluating the safety and efficacy of oral azacitidine in subjects with myelodysplastic syndromes who failed to achieve an objective response to injectable hypomethylating agent treatment. An extension phase has been added to allow subjects who are currently receiving oral azacitidine and demonstrating clinical benefit to continue receiving the treatment until they meet the criteria for study discontinuation.
Who is the study for?
Adults diagnosed with Myelodysplastic Syndromes (MDS) who didn't respond to previous injectable hypomethylating agents can join this trial. They should have stable disease or disease progression after the last treatment, be in good enough health for daily activities (ECOG 0-2), and not be pregnant or breastfeeding. People with rapidly progressing MDS, acute myeloid leukemia, recent serious heart issues, uncontrolled infections, certain other cancers within the last 3 years, or known allergies to study drugs are excluded.Check my eligibility
What is being tested?
The trial is testing oral azacitidine (CC-486) taken twice daily by patients with MDS who haven't responded well to prior treatments. The combination arm with durvalumab was closed due to dose-finding difficulties. Patients benefiting from CC-486 may continue in an extension phase until they no longer meet study criteria.See study design
What are the potential side effects?
Oral azacitidine may cause side effects like nausea, vomiting, diarrhea, constipation, fatigue and weakness; low blood cell counts leading to increased risk of infection; bleeding or bruising more easily than normal; and liver function changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ response was assessed every 2 cycles following treatment during the first 6 cycles, then every 3 cycles thereafter; median duration of treatment = 5.26 and 3.81 months for sd/pd for oral aza arms respectively, and 1.84 months for aza and durva sd/pd arms
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~response was assessed every 2 cycles following treatment during the first 6 cycles, then every 3 cycles thereafter; median duration of treatment = 5.26 and 3.81 months for sd/pd for oral aza arms respectively, and 1.84 months for aza and durva sd/pd arms
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate Based on the Modified International Working Group (IWG) 2006 Response Criteria for Myelodysplastic Syndrome (MDS)
Secondary outcome measures
Kaplan Meier Estimate of Duration of Best Response
Kaplan Meier Estimate of Duration of First Response
Kaplan Meier Estimate of Time to Onset of First and Best Response
+8 moreSide effects data
From 2023 Phase 3 trial • 216 Patients • NCT0156669576%
Nausea
68%
Diarrhoea
63%
Vomiting
49%
Neutropenia
47%
Constipation
28%
Pyrexia
27%
Thrombocytopenia
27%
Febrile neutropenia
27%
Oedema peripheral
26%
Epistaxis
25%
Decreased appetite
23%
Asthenia
21%
Fatigue
20%
Petechiae
18%
Anaemia
15%
Cough
14%
Contusion
13%
Abdominal pain
12%
Dyspnoea
12%
Back pain
11%
Urinary tract infection
11%
Hypokalaemia
9%
Weight decreased
9%
Leukopenia
9%
Insomnia
9%
Pneumonia
9%
Mouth haemorrhage
9%
Hypomagnesaemia
9%
Haematoma
8%
Anxiety
8%
Alanine aminotransferase increased
8%
Arthralgia
7%
Sepsis
7%
Dizziness
7%
Gingival bleeding
7%
Upper respiratory tract infection
7%
Pain in extremity
6%
Depression
6%
Confusional state
6%
Septic shock
6%
Gastrooesophageal reflux disease
6%
Cellulitis
6%
Oral herpes
6%
Serum ferritin increased
6%
Hyperglycaemia
6%
Iron overload
6%
Ecchymosis
6%
Hypotension
5%
Neutropenic sepsis
4%
Fall
3%
Lung infection
3%
General physical health deterioration
3%
Cardiac failure congestive
2%
Tachyarrhythmia
2%
Bone marrow failure
2%
Cardiac failure
2%
Multiple organ dysfunction syndrome
2%
Cholecystitis
2%
Hyperbilirubinaemia
2%
Atypical pneumonia
2%
Bronchopulmonary aspergillosis
2%
Subdural haematoma
2%
Haemorrhage intracranial
2%
Acute kidney injury
2%
Renal failure
1%
Gastroenteritis
1%
Corona virus infection
1%
Prerenal failure
1%
Escherichia sepsis
1%
Myocardial infarction
1%
Abdominal pain upper
1%
Gastritis
1%
Epididymitis
1%
Febrile infection
1%
Pancytopenia
1%
Renal colic
1%
Chronic kidney disease
1%
Lethargy
1%
Groin abscess
1%
Lower respiratory tract infection
1%
Device related infection
1%
Influenza
1%
Klebsiella infection
1%
Haemolytic anaemia
1%
Haemorrhagic anaemia
1%
Acute myocardial infarction
1%
Angina unstable
1%
Atrial fibrillation
1%
Gastrointestinal haemorrhage
1%
Intestinal obstruction
1%
Intestinal perforation
1%
Neutropenic colitis
1%
Oesophageal achalasia
1%
Oral mucosal blistering
1%
Rectal haemorrhage
1%
Gait disturbance
1%
Hypothermia
1%
Abscess limb
1%
Arteriovenous fistula site infection
1%
Klebsiella sepsis
1%
Meningitis
1%
Meningitis bacterial
1%
Myringitis
1%
Pneumonia fungal
1%
Pneumonia pneumococcal
1%
Pseudomonal sepsis
1%
Pulmonary mycosis
1%
Respiratory tract infection
1%
Skin infection
1%
Staphylococcal infection
1%
Urinary tract infection bacterial
1%
Viral sepsis
1%
Periorbital haematoma
1%
Febrile nonhaemolytic transfusion reaction
1%
Head injury
1%
Hip fracture
1%
Subdural haemorrhage
1%
Upper limb fracture
1%
Dehydration
1%
Diabetes mellitus inadequate control
1%
Diabetic metabolic decompensation
1%
Hyperkalaemia
1%
Hypoglycaemia
1%
Muscular weakness
1%
Polychondritis
1%
Acute myeloid leukaemia
1%
Bone neoplasm
1%
Bowen's disease
1%
Colon adenoma
1%
Mantle cell lymphoma recurrent
1%
Spinal cord neoplasm
1%
Central nervous system lesion
1%
Transient ischaemic attack
1%
Epilepsy
1%
Generalised tonic-clonic seizure
1%
Acute respiratory distress syndrome
1%
Pleural effusion
1%
Pleurisy
1%
Pneumonia aspiration
1%
Pulmonary embolism
1%
Respiratory failure
1%
Hypersensitivity vasculitis
1%
Rash
1%
Rash generalised
1%
Shock haemorrhagic
1%
Cardiogenic shock
1%
Intra-abdominal haemorrhage
1%
Status epilepticus
1%
Syncope
1%
Urinary retention
1%
Prostatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Azacitidine Plus Best Supportive Care
Placebo Plus Best Supportive Care
Trial Design
2Treatment groups
Experimental Treatment
Group I: Monotherapy: Oral AzacitidineExperimental Treatment1 Intervention
Oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
Group II: Combination Therapy: Oral Azacitidine and DurvalumabExperimental Treatment2 Interventions
Oral Azacitidine 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous (IV) infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral Azacitidine
2013
Completed Phase 3
~480
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
CelgeneLead Sponsor
636 Previous Clinical Trials
128,906 Total Patients Enrolled
C.L. Beach, PharmDStudy ChairCelgene
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,506 Previous Clinical Trials
3,369,465 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria: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.
Research Study Groups:
This trial has the following groups:- Group 1: Monotherapy: Oral Azacitidine
- Group 2: Combination Therapy: Oral Azacitidine and Durvalumab
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings for individuals to partake in this experiment?
"Unfortunately, this trial is not presently recruiting. It was initially posted on July 6th 2015 and the latest update being from October 28th 2022. However, 1595 clinical trials are accepting patients with myelodysplastic syndromes while 504 studies exist for Oral Azacitidine actively recruiting participants."
Answered by AI
What is the current enrolment capacity for this clinical trial?
"This medical trial is currently not accepting applicants. It was first announced on July 6th, 2015 and the last update occurred on October 28th 2022. For those looking for alternative trials, there are 1595 studies related to myelodysplastic syndromes that are recruiting patients as well as 504 clinical trials involving Oral Azacitidine which have open enrollment periods."
Answered by AI
Which medical conditions is Oral Azacitidine frequently employed to treat?
"Oral Azacitidine can be utilized to manage complete blood count, induction chemotherapy, refractory anemias, and a range of leukemias."
Answered by AI
What locations offer access to this research endeavor?
"Among the 15 participating medical centres are John Theurer Cancer Centre at Hackensack University Medical Center in Hackeck, Icahn School of Medicine at Mount Sinai in New york City and H Lee Moffitt Cancer Centre & Research Institute located in Tampa."
Answered by AI
Has Oral Azacitidine been tested in past research studies?
"Oral Azacitidine was first trialled in 2006 at the Chinese University of Hong Kong-Prince of Wales Hospital. At present, 263 studies have concluded and there are 504 active investigations occurring across the world - many located in Hackensack, New jersey."
Answered by AI
What sort of risks are associated with Oral Azacitidine treatment?
"According to Power's assessment, oral azacitidine has been allotted a score of 2 out of 3 in terms of safety. This evaluation is based on the fact that this medical trial is in its second phase and there exists clinical evidence supporting its security but not yet any attesting to its efficacy."
Answered by AI
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