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Anti-metabolites

Oral Azacitidine for Leukemia

Phase 1 & 2
Recruiting
Led By John Reneau, MD
Research Sponsored by John Reneau
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptomatic anemia with hemoglobin < 10 g/dL
Diagnosis of T-LGLL defined as: CD3+CD8+ cell population > 650/mm^3 and the presence of a clonal T-cell receptor (within 1 month of diagnosis). Note: patients with myelodysplastic syndrome (MDS)-like T-LGLL may be included with principal investigator (PI) approval even if CD3+CD8+ cell population is < 650/mm^3, though +TCR is required. Natural-killer (NK) large granular lymphocytic leukemia (LGL) is also permitted, provided there is a clonal NK-cell population noted with > 500 cells/mm^3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing azacitidine to see if it can help patients with T-cell large granular lymphocytic leukemia that has returned or did not respond to previous treatment.

Who is the study for?
Adults with relapsed or refractory T-cell large granular lymphocytic leukemia who need treatment and have not used certain drugs like 5-azacytidine. They must be able to consent, have a decent performance status, meet specific blood count criteria, agree to use birth control, and be off previous treatments for a set time. Those with active infections or on immune-suppressive therapy (beyond low-dose prednisone) are excluded.Check my eligibility
What is being tested?
The trial is testing oral Azacitidine to find the best dose and assess its benefits/side effects in patients whose T-cell large granular lymphocytic leukemia has returned after treatment or didn't respond at all. It's a phase I/II study which means they're looking at safety as well as how well it works.See study design
What are the potential side effects?
Oral Azacitidine may cause side effects such as nausea, vomiting, diarrhea, constipation, loss of appetite; fatigue; muscle or joint pain; injection site reactions if given subcutaneously; and lowered blood cell counts leading to increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My hemoglobin is below 10 g/dL and I feel very tired.
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I have been diagnosed with a specific type of leukemia (T-LGLL or NK LGL) based on my blood cell counts and genetic tests.
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I need regular blood transfusions for my anemia.
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I agree to use effective birth control during the study.
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I have tried at least one treatment for my condition and stopped it more than 14 days ago or 5 half-lives ago, whichever is longer.
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I need treatment for T-LGL leukemia.
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I am 18 years old or older.
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I can take care of myself and perform daily activities.
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I have low white blood cell counts and get infections often.

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
Azacitidine
Overall response rate (complete response [CR] + partial response [PR]) (Phase II)
Secondary outcome measures
Degree of IL-15 promoter demethylation in responders versus non-responders
Duration of response to CC-486
Progression-free survival (PFS
+5 more

Side effects data

From 2023 Phase 3 trial • 216 Patients • NCT01566695
76%
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

1Treatment groups
Experimental Treatment
Group I: Treatment (Oral Azacitidne)Experimental Treatment1 Intervention
Patients will receive CC-486 orally (PO) D1-14 of a 28-day cycle, in a similar fashion to the QUAZAR study for a minimum of 4 cycles. Patients that achieve a response (CR or PR) will remain on study for a maximum of 12 months. Patients without a response at 4 months will come off the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral Azacitidine
2013
Completed Phase 3
~480

Find a Location

Who is running the clinical trial?

John ReneauLead Sponsor
3 Previous Clinical Trials
66 Total Patients Enrolled
Jonathan BrammerLead Sponsor
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,493 Total Patients Enrolled

Media Library

Oral Azacitidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05141682 — Phase 1 & 2
Large Granular Lymphocyte Leukemia Research Study Groups: Treatment (Oral Azacitidne)
Large Granular Lymphocyte Leukemia Clinical Trial 2023: Oral Azacitidine Highlights & Side Effects. Trial Name: NCT05141682 — Phase 1 & 2
Oral Azacitidine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05141682 — Phase 1 & 2

Frequently Asked Questions

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

What maladies can best be addressed with Oral Azacitidine?

"Oral Azacitidine is a frequently used intervention for treating malignant neoplasms, having at least 20-30% blast cells in the blood and neutropenia or thrombocytopenia."

Answered by AI

Is the research team currently recruiting participants?

"Per the information posted by clinicaltrials.gov, this research project is presently seeking volunteers for participation. It was first published on May 1st 2022 and has been modified most recently on April 18th 2022."

Answered by AI

What is the maximum number of participants being accepted for this research?

"Affirmative. According to information hosted on the clinicaltrials.gov website, this trial was initially publicized on May 1st 2022 and updated lastly on April 18th 2022. The study is recruiting 21 patients at a single medical centre for participation."

Answered by AI

What precedent studies have been conducted regarding Oral Azacitidine?

"Currently, 173 trials are investigating the potential of Oral Azacitidine to treat various ailments. Of these ongoing studies, 32 have entered Phase 3 testing. While a majority of these clinical studies for this medication take place in Saint Louis, Missouri, there are 5664 other locations hosting related experiments."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Oral Azacitidine for the Treatment of Relapsed or Refractory T-cell Large Granular Lymphocytic Leukemia
John Reneau 2022. "Oral Azacitidine for the Treatment of Relapsed or Refractory T-cell Large Granular Lymphocytic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05141682.
~6 spots leftby Dec 2024
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