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Anti-metabolite

Azacitidine + Quizartinib for Myelodysplastic Syndrome

Phase 1 & 2
Recruiting
Led By Guillermo M Bravo
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
Diagnosis of myelodysplastic syndrome (MDS) or MDS/myeloproliferative neoplasm (MPN) including chronic myelomonocytic leukemia (CMML) according to World Health Organization (WHO)
For hypomethylating agent naive patients: int-2 or higher by International Prognostic Scoring System (IPSS) or > 5% bone marrow blasts if MDS or dysplastic CMML (white blood cell [WBC] < 13 x 10^9/L). Patients with proliferative (WBC >= 13 x 10^9/L) CMML or MDS/MPN, or those with dysplastic CMML with high-risk molecular features (mutations in ASXL1, TP53 or more than 3 mutations) are also eligible independently of IPSS risk score or bone marrow blast percentage
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of quizartinib when given with azacitidine to people with myelodysplastic syndrome or myelodysplastic/myeloproliferative neoplasm with FLT3 or CBL mutations.

Who is the study for?
This trial is for adults with myelodysplastic syndrome or related conditions, who have specific FLT3 or CBL mutations. It's open to those new to treatment and those who didn't respond to previous therapies. Participants should be in decent health otherwise, with acceptable organ function and no severe heart issues.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: Azacitidine, a chemotherapy drug that stops cancer cells from growing, and Quizartinib, which blocks enzymes needed by cancer cells. The study aims to find the best dose and see how well these drugs work together against certain blood disorders.See study design
What are the potential side effects?
Potential side effects may include typical chemotherapy-related reactions like nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems. Heart rhythm disturbances could also occur due to Quizartinib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with MDS or a related condition.
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I have not used hypomethylating agents and my blood condition is considered high-risk.
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I did not respond to or my condition worsened after treatment with specific agents.
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I am able to care for myself and perform daily activities.
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I did not respond to or my condition worsened after treatment with specific agents.
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I am able to get out of my bed or chair and move around.
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I have been diagnosed with MDS or a related condition.
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My cancer has a specific genetic mutation (FLT3-ITD or CBL).
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My cancer has a specific genetic mutation (FLT3-ITD or CBL).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
Duration of response
Incidence of adverse events (AEs)
Leukemia free survival
+3 more

Side effects data

From 2020 Phase 3 trial • 367 Patients • NCT02039726
47%
Nausea
37%
Pyrexia
36%
Anemia
33%
Vomiting
32%
Hypokalemia
28%
Diarrhea
28%
Fatigue
26%
Thrombocytopenia
26%
Electrocardiogram QT prolonged
23%
Cough
21%
Febrile neutropenia
21%
Edema peripheral
21%
Headache
20%
Decreased appetite
20%
Dyspnea
20%
Neutropenia
20%
Constipation
16%
Stomatitis
15%
Hypomagnesemia
15%
Rash
15%
Dizziness
15%
White blood cell count decreased
14%
Asthenia
14%
Platelet count decreased
13%
Hypotension
13%
Alanine aminotransferase increased
13%
Neutrophil count decreased
12%
Epistaxis
12%
Abdominal pain
11%
Weight decreased
11%
Hypocalcemia
11%
Aspartate aminotransferase increased
11%
Petechiae
11%
Back pain
10%
Hypophosphatemia
10%
Blood bilirubin increased
10%
Oropharyngeal pain
10%
Pain in extremity
9%
Dysgeusia
9%
Hyponatremia
9%
Pneumonia
9%
Insomnia
8%
Musculoskeletal pain
8%
Anxiety
8%
Arthralgia
8%
Muscle spasms
8%
Dyspepsia
8%
Pain
7%
Urinary tract infection
7%
Hypoalbuminemia
7%
Graft versus host disease in skin
7%
Upper respiratory tract infection
7%
Sepsis
7%
Blood alkaline phosphatase increased
7%
Blood creatinine increased
7%
Gingival bleeding
7%
Abdominal pain upper
6%
Hyperglycemia
6%
Dysuria
6%
Skin lesion
6%
Graft versus host disease
6%
Chills
6%
Contusion
6%
Leukocytosis
6%
Pruritis
6%
Myalgia
6%
Pleural effusion
5%
Dry mouth
5%
Dry eye
5%
Leukopenia
5%
Abdominal distension
4%
Device related infection
4%
Hypertension
4%
Nasal congestion
3%
Neutropenic sepsis
3%
Sinus tachycardia
3%
Confusional state
3%
Proctalgia
2%
Cellulitis
2%
Septic shock
2%
Hemorrhage intracranial
2%
Bacteremia
2%
Graft versus host disease in intestine
2%
Syncope
2%
Staphylococcal infection
1%
Escherichia sepsis
1%
Skin infection
1%
Acute febrile neutrophilic dermatosis
1%
Rash generalized
1%
Cerebral hemorrhage
1%
Clostridium difficile infection
1%
Klebsiella sepsis
1%
Lung infection
1%
Pneumonia fungal
1%
Staphylococcal bacteremia
1%
Hematuria
1%
Atrial fibrillation
1%
Pericarditis
1%
Pneumonitis
1%
Respiratory failure
1%
Pancytopenia
1%
Enterobacter infection
1%
Infection
1%
Gastroenteritis
1%
Neutropenic infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Quizartinib
Salvage Chemotherapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (azacitidine, quizartinib)Experimental Treatment2 Interventions
Patients receive azacitidine SC or IV over about 30 minutes on days 1-5 and quizartinib PO QD on days 1-28. 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
Quizartinib
2016
Completed Phase 3
~1110
Azacitidine
2012
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,289 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,307 Total Patients Enrolled
Guillermo M BravoPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
166 Total Patients Enrolled

Media Library

Azacitidine (Anti-metabolite) Clinical Trial Eligibility Overview. Trial Name: NCT04493138 — Phase 1 & 2
Chronic Myelomonocytic Leukemia Research Study Groups: Treatment (azacitidine, quizartinib)
Chronic Myelomonocytic Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT04493138 — Phase 1 & 2
Azacitidine (Anti-metabolite) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04493138 — 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 medical indications typically warrant Quizartinib treatment?

"Quizartinib is a viable option for treating malignant neoplasms, neutropenia and/or thrombocytopenia with greater than 20-30% blasts."

Answered by AI

What prior research exists on Quizartinib?

"Currently, there are 182 clinical trials examining the effects of Quizartinib with 33 at Phase 3. Despite Saint Louis hosting a considerable number of these studies, there is an aggregate of 6,024 medical centres conducting trial for this medication around the world."

Answered by AI

Is enrollment open for this experiment?

"Indeed, according to clinicaltrials.gov this medical trial is actively looking for participants. The listing was originally created on July 21st 2020 and the most recent update happened on May 23rd 2022; 58 volunteers are needed at a single site."

Answered by AI

What is the cohort size for this research initiative?

"Affirmative, the information available on clinicaltrials.gov states that this medical trial is currently looking for volunteers. The experiment was first published in July of 2020 and edited most recently in May 2022; 58 participants are required at a single site."

Answered by AI
~10 spots leftby Dec 2024