← Back to Search

FLT3 Inhibitor

Quizartinib for Acute Leukemia

Phase 1 & 2

Waitlist Available

Led By Naval G 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 the side effects and best dose of a combination of two drugs, venetoclax and quizartinib, in treating patients with FLT3-mutation positive acute myeloid leukemia that has come back or does not respond to treatment.

Eligible Conditions

Acute Leukemia
Acute Myeloid 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Composite complete remission rate (CRc) rate including CR + complete remission with incomplete platelet recovery (CRp) + complete remission with incomplete count recovery (CRi) (Phase II)

Maximum tolerated dose (MTD) as determined by dose limiting toxicity (Phase Ib)

Recommended phase II dose as determined by MTD (Phase Ib)

Secondary outcome measures

Characterization of pharmacokinetic profiles (Phase Ib)

Composite CRc rate including CR + CRp + CRi (Phase Ib)

DOR (Phase II)

+14 more

Other outcome measures

Analysis of surplus blood and tissue including bone marrow for future exploratory research

Assessment of gene sequencing and clinical response to combination treatment

Changes of FLT3-internal tandem duplication (ITD) allelic burden

+2 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

Dysgeusia

Hyponatremia

Pneumonia

Insomnia

Musculoskeletal pain

Anxiety

Arthralgia

Muscle spasms

Dyspepsia

Pain

Urinary tract infection

Hypoalbuminemia

Graft versus host disease in skin

Upper respiratory tract infection

Sepsis

Blood alkaline phosphatase increased

Blood creatinine increased

Gingival bleeding

Abdominal pain upper

Hyperglycemia

Dysuria

Skin lesion

Graft versus host disease

Chills

Contusion

Leukocytosis

Pruritis

Myalgia

Pleural effusion

Dry mouth

Dry eye

Leukopenia

Abdominal distension

Device related infection

Hypertension

Nasal congestion

Neutropenic sepsis

Sinus tachycardia

Confusional state

Proctalgia

Cellulitis

Septic shock

Hemorrhage intracranial

Bacteremia

Graft versus host disease in intestine

Syncope

Staphylococcal infection

Escherichia sepsis

Skin infection

Acute febrile neutrophilic dermatosis

Rash generalized

Cerebral hemorrhage

Clostridium difficile infection

Klebsiella sepsis

Lung infection

Pneumonia fungal

Staphylococcal bacteremia

Hematuria

Atrial fibrillation

Pericarditis

Pneumonitis

Respiratory failure

Pancytopenia

Enterobacter infection

Infection

Gastroenteritis

Neutropenic infection

100%

80%

60%

40%

20%

Study treatment Arm

Quizartinib

Salvage Chemotherapy

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (venetoclax, quizartinib)Experimental Treatment2 Interventions

Patients receive quizartinib PO QD on days 1-28 and venetoclax PO QD beginning on day 8 of cycle 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment beyond 24 cycles at the discretion of the treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Quizartinib

Not yet FDA approved

Venetoclax

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,659 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,794 Total Patients Enrolled

Naval G DaverPrincipal InvestigatorM.D. Anderson Cancer Center

3 Previous Clinical Trials

177 Total Patients Enrolled

Frequently Asked Questions

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

Could you please inform me if any positions are open for this trial?

"At present, this trial is not recruiting participants. It was initially posted on the 25th of January 2019 and last updated on September 14th 2022. Should you be interested in exploring alternative medical studies, there are currently 1464 trials for leukemia, myeloid acute actively enrolling patients and 226 specifically looking into Quizartinib interventions."

Answered by AI

Are there any other investigations involving Quizartinib that have been executed in the past?

"At the current moment, 226 studies are evaluating Quizartinib. Out of those, 29 have reached Phase 3 and 7550 research centres worldwide are taking part in these trials. Boston has a particularly large concentration of sites running clinical experiments for this medication."

Answered by AI

How many individuals are participating in this research endeavor?

"This clinical trial has ceased recruitment. It was initially posted on the 25th of January 2019, and was last updated on September 14th 2022. For those looking for other trials related to leukemia, myeloid, acute there are currently 1464 studies actively recruiting participants. Quizartinib also has 226 studies in search of patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia

2019. "Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03735875.