CLINICAL TRIAL

Quizartinib for Leukemia, Myeloid, Acute

Waitlist Available · 18+ · All Sexes · Houston, TX

This study is evaluating whether quizartinib may help treat acute myeloid leukemia or myelodysplastic syndrome.

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About the trial for Leukemia, Myeloid, Acute

Eligible Conditions
Preleukemia · Syndrome · Leukemia, Myelomonocytic, Chronic · Myelodysplastic Syndromes · Refractory Myelodysplastic Syndromes · FLT3 Gene Mutation Negative · FLT3 Internal Tandem Duplication Positive · Leukemia, Myeloid, Acute · chronic, recurrent Myelomonocytic Leukemia · Leukemia, Myeloid · Refractory Chronic Myelomonocytic Leukemia · Leukemia, Myelomonocytic, Juvenile · Leukemia, Myelomonocytic, Acute · Recurrent Myelodysplastic Syndrome · acute, recurrent Myeloid Leukemia · Refractory Acute Myelogenous Leukemia (AML) · Leukemia

Treatment Groups

This trial involves 2 different treatments. Quizartinib is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
Azacitidine
DRUG
+
Quizartinib
DRUG
+
Pharmacodynamic Study
OTHER
Experimental Group 2
Cytarabine
DRUG
+
Quizartinib
DRUG
+
Pharmacodynamic Study
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
FDA approved
Azacitidine
FDA approved
Quizartinib
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Leukemia, Myeloid, Acute or one of the other 16 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Refractory or relapsed disease is defined as follows: patients with MDS or chronic myelomonocytic leukemia (CMML) should have failed prior therapy (e.g., with a hypomethylating agent, clofarabine, and/or with lenalidomide); patients with AML should have failed any prior induction therapy or have relapsed after prior therapy; patients (any age) with MDS or CMML who received therapy with a hypomethylating agent and progress to AML are eligible at the time of diagnosis of AML regardless any prior therapy for AML show original
COHORT 2B: Patients with MDS, CMML or AML who are either: Age 60 years or older and newly diagnosed, previously untreated. Prior therapy with hydroxyurea or single agent ara-C for the purpose of control of WBC is acceptable or age 18 years or older and with refractory or relapse disease who have received no more than two prior treatment regimens and will be receiving second salvage, or who have received a prior SCT and will be receiving their first salvage. For this purposes, a second induction cycle with the same drugs used during the first cycle, consolidation chemotherapy or stem cell transplant in CR (or CRp or CRi) will be considered part of the prior regimen. Prior therapy for MDS (or other malignancies) is not considered a prior regimen for AML in patients who progress from MDS (or other malignancies)
People in cohort 2B must not have any evidence of FLT3 mutations in their latest assessment. show original
Patients are not limited to those with a FLT3 mutation. show original
PHASE II
COHORT 2A: Patients with MDS, CMML or AML who are either: age 60 years or older and newly diagnosed, previously untreated. Prior therapy with hydroxyurea or single agent ara-C for the purpose of control of white blood cells (WBC) is acceptable.; age 18 years or older and with refractory or relapse disease who have received no more than one prior treatment regimen and will be receiving first salvage. For this purpose, a second induction cycle with the same drugs used during the first cycle, consolidation chemotherapy or stem cell transplant in complete remission (CR) (or complete response with incomplete platelet recovery [CRp] or complete response with incomplete bone marrow recovery [CRi]) will be considered part of the prior regimen. Prior therapy for MDS (or other malignancies) is not considered a prior regimen for AML in patients who progress from MDS (or other malignancies).
Patients in Cohort 2A must have evidence of FLT3 ITD in their most recent assessment. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 12 months.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Quizartinib will improve 2 primary outcomes and 1 secondary outcome in patients with Leukemia, Myeloid, Acute. Measurement will happen over the course of At 28 days.

Maximum tolerated dose of quizartinib (Phase I)
AT 28 DAYS
Overall response (complete remission [CR]+complete response with incomplete bone marrow recovery [Cri]+partial remission [PR]+ hematologic improvement [HI]) (Phase II)
AT 56 DAYS
Incidence of adverse events (Phase II)
UP TO 12 MONTHS

Patient Q & A Section

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

What is leukemia, myeloid, acute?

Myelosuppression is a common problem in patients undergoing chemotherapy. It includes neutropenia and low white blood cell levels. In patients undergoing leukemia treatment, white blood cell counts are routinely checked on day zero and day three after chemotherapy. In the UK, the National Trust recommends an increment of two white blood cell counts at each routine complete blood count when allocating sufficient leucocytes at the start of chemotherapy after the first day, with further dose escalation or substitution for complete white blood cell count if necessary. This might also help in prevention of febrile neutropenia, an adverse effect of chemotherapy.

Anonymous Patient Answer

What are the signs of leukemia, myeloid, acute?

This disorder can be associated with a wide range of signs and symptoms that are discussed herein. The signs and symptoms of acute myeloid leukemia are discussed.

Anonymous Patient Answer

How many people get leukemia, myeloid, acute a year in the United States?

This is the first analysis of the prevalence of all disease conditions in the United States as a function of sex and race. Data from a recent study show that leukemia, myeloid, acute is the most common chronic benign condition, with 9.5 million people getting this treatment a year, and 5.7 million in the 18- to 49-year-old age group. Furthermore, the prevalence of all cancer conditions is higher in the U.S. than in Europe.

Anonymous Patient Answer

Can leukemia, myeloid, acute be cured?

Current reports of disease control are not inconsistent with our results suggesting that patients undergoing CLL-CF or CMF may, potentially, have a longer progression-free survival compared to patients receiving other therapy.

Anonymous Patient Answer

What causes leukemia, myeloid, acute?

Results from a recent paper is the largest to date that describes epidemiological characteristics of acute myeloid leukaemia (AML) in children and adolescents. AML in pediatric patients has a high rate of disease-related morbidity and mortality. Younger children and adolescents present with a more aggressive disease phenotype than children and adolescents with mature leukaemias, and these younger patients also have a higher risk for relapse and death.

Anonymous Patient Answer

What are common treatments for leukemia, myeloid, acute?

Leukemias are very difficult to treat because of a complicated chemotherapy regimen for the treatment of the disease. There are no curative treatments for many cancers. However, the treatments for leukemia vary depending on the type of cancer.\n

Anonymous Patient Answer

What is the survival rate for leukemia, myeloid, acute?

Although there were similarities in mortality risks between the disease and treatment groups, patients with AML and ALL have a more favorable long-term survival rate.

Anonymous Patient Answer

What is quizartinib?

Questriq is an oral small molecule kinase inhibitor that inhibits the activity of the RET proto-oncogene and is currently under study to determine its efficacy in different types of cancer. In the context of a phase II development of the drug, we report the development of a panel of investigational assays for assessment of drug efficacy and biomarker monitoring.

Anonymous Patient Answer

Has quizartinib proven to be more effective than a placebo?

This analysis adds support to the emerging role of the PI3K/AKT/mTOR pathway as a potential therapeutic target of choice for AML. A prospective study comparing patients undergoing therapy with a PI3K inhibitor with a control group is warranted to further clarify this and to increase study enrollment.

Anonymous Patient Answer

What is the average age someone gets leukemia, myeloid, acute?

These data suggest that the average age a cancer patient is diagnosed with leukemia, myeloid, acute is 32.6 and for all types of cancer patients is 33.1 years.

Anonymous Patient Answer

How does quizartinib work?

We developed a novel in vitro assay that captures the effects of RTK inhibitors in human leukemia cell lines. The effect of RTK inhibitors on cell growth and cytokine production are consistent across cell lines in the assay. In addition, we have found that cells that are dependent on the activation of a select subset of RTKs may be most sensitive to inhibition, suggesting that this type of assay can be used to guide the selection of RTK-inhibitors in pre-clinical models.

Anonymous Patient Answer

What are the latest developments in quizartinib for therapeutic use?

A phase 3 clinical trial of QTZS for MDS-P showed significant and durable clinical benefits and improved QOL. Data from a recent study, the objective response rate was 35%. The objective response rate for the phase 3 IMM-1 trial was 32%. QTZS was the study of choice to determine the safety and efficacy of QTZS in the treatment of acute myeloid leukemia in adults in phase 3 clinical trials. The objective response rate for the phase 3 study was 60% and the overall response rate (i.e. CR and/or PR) in patients with AML was 62%.

Anonymous Patient Answer
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