CLINICAL TRIAL

Venetoclax for Leukemia, Myeloid, Acute

Recruiting · 18+ · All Sexes · Omaha, NE

Integrating Geriatric Assessment and Genetic Profiling to Personalize Therapy Selection in Older Adults With Acute Myeloid Leukemia

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About the trial for Leukemia, Myeloid, Acute

Eligible Conditions
Leukemia, Myeloid · Secondary Acute Myeloid Leukemia (Secondary AML, sAML) · Leukemia, Myeloid, Acute · Adult Acute Myeloid Leukemia · Leukemia · Therapy-Related Acute Myeloid Leukemia

Treatment Groups

This trial involves 2 different treatments. Venetoclax 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 2 and have already been tested with other people.

Experimental Group 1
Liposome-encapsulated Daunorubicin-Cytarabine
DRUG
+
Cytarabine
DRUG
+
Laboratory Biomarker Analysis
OTHER
+
Quality-of-Life Assessment
OTHER
+
Questionnaire Administration
OTHER
+
Idarubicin
DRUG
Experimental Group 2
Decitabine
DRUG
+
Laboratory Biomarker Analysis
OTHER
+
Azacitidine
DRUG
+
Quality-of-Life Assessment
OTHER
+
Questionnaire Administration
OTHER
+
Venetoclax
DRUG
+
glasdegib
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
FDA approved
Decitabine
FDA approved
Cytarabine
FDA approved
Azacitidine
FDA approved
Venetoclax
FDA approved
Glasdegib
FDA approved
Idarubicin
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 5 conditions listed above. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients aged ≥60 years
A new diagnosis of de novo, secondary or treatment-related AML, other AML equivalent such as myeloid sarcoma, myelodysplastic syndrome in transformation to AML, or high-grade treatment-related myeloid neoplasm
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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 4 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 4 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- 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 Venetoclax will improve 1 primary outcome and 8 secondary outcomes in patients with Leukemia, Myeloid, Acute. Measurement will happen over the course of From the time of diagnosis to death, assessed up to 90 days.

Mortality
FROM THE TIME OF DIAGNOSIS TO DEATH, ASSESSED UP TO 90 DAYS
Mortality at 90 days will be calculated as the time from date of diagnosis to date of death due to any cause by 90 days from diagnosis.
Symptom burden
UP TO 90 DAYS FOLLOWING INITIATION OF CHEMOTHERAPY
Will determine the symptom burden at diagnosis and 10, 30 and 90 days following initiation of chemotherapy.
Functional status
UP TO 90 DAYS
The association between functional status and grade 3/4 toxicities will be explored using ANOVA; if assumptions of ANOVA fail, Kruskal Wallis will be used.
Baseline functional status
UP TO 90 DAYS
Will evaluate the influence of baseline functional status on the quality of life and neurocognitive status. The association between categories of functional status and quality of life will be explored using analysis of variance (ANOVA); if assumptions of ANOVA fail, Kruskal Wallis will be used. The association between functional status (fit or vulnerable) and neurocognitive status (< 25 or 26 or higher) will be explored using a chi-square test. A generalized linear mixed model will be utilized to evaluate changes in quality of life over time. The proportion (and associated 95% confidence interval) of patients with definitely or probably modifiable impairments will be presented.
Rate of complete remission and mortality in the entire cohort of older patients
AT 90 DAYS
All analyses will be performed based on intent-to-treat principle. The method of inversion will be used to generate an interval estimate for the proportion of 90-day mortality.
Baseline functional status measure by geriatric assessment
AT 90 DAYS
Will assess the impact of baseline functional status on the rate of complete remission and mortality.
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Who is running the study

Principal Investigator
V. B.
Vijaya Bhatt, Principal Investigator
University of Nebraska

Patient Q & A Section

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

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

The American Cancer Society estimates 64,620 new cases of acute leukemias will be made in 1986. In addition the estimate of 67,300 new cases of myeloid, acute leukemias will be made in 1986. In 1989, the ACS estimates 30,040 new cases of acute myeloid leukemia and 33,900 new cases of acute lymphoblastic leukemia. (In both case, only pediatric cases are counted.) In the same year, the ACS estimates 15,110 deaths due to chronic myeloid and acute lymphocytic leukemia and 13,390 deaths due to myeloid and lymphocytic leukemias.

Anonymous Patient Answer

What causes leukemia, myeloid, acute?

The genetic make-up of a sub-population of individuals may explain the onset of a predisposition to developing leukemias. Although the reasons for this predisposition to leukemia in individuals, who are genetically susceptible, remain difficult to explain, our study indicates at least two distinct genetic mechanisms leading to this predisposition.

Anonymous Patient Answer

What is leukemia, myeloid, acute?

Leukemia, myeloid, acute is a leukemias that form in bone marrow or other blood cells. It typically appears in adults over the age of 15. Roughly 100 infants were diagnosed with leukemia, myeloid, acute in 2015, however the disease has been increasingly diagnosed in children since 2000. The most common forms of leukemia, myeloid, acute are chronic myeloid leukemia and acute myeloid leukemia. Leukemia, myeloid, acute was one of 22 acute leukemia types in 2015.

Anonymous Patient Answer

What are common treatments for leukemia, myeloid, acute?

The current literature confirms that all three cancer types respond favorably to treatment regimens of different chemotherapy regimens. Each of these regimens may be used to treat all 3 types of cancer. The combination of cytotoxic chemotherapy with bone marrow transplantation has been shown to improve both survival and quality of life in most patients with acute myeloidal leukemia that complicates chronic active Epstein-Barr virus disease. Survival improves even more with an autograft. The improvement in prognosis afforded by this treatment modality was recognized in the 2000 World Health Organization classification of lymphomas and has been incorporated into the current WHO classification as well (i.e., diffuse large B-cell lymphoma, chronic lymphocytic leukemia, and mantle cell lymphoma).

Anonymous Patient Answer

What are the signs of leukemia, myeloid, acute?

Leukemias are typically characterized by their symptoms and symptoms will appear after a couple of days for leukemia and after 2 weeks for AML or ALL. Other signs include high white blood cell counts, headaches, fatigue, and low platelet counts. Leukemias can also be diagnosed at diagnosis by observing symptoms and symptoms that arise from infiltration by leukemic cells in the body.

Anonymous Patient Answer

Can leukemia, myeloid, acute be cured?

Currently, there is no effective treatment for ALL. Although CML and CLL have response rates of up to 70% and 50%, respectively, they both relapse quickly, sometimes within 1 year of having responded to therapy. Allogeneic HSCT, or the use of some other modality to eradicate the clone of CLL in the bone marrow, is the only curative treatment for CLL. As a result, this type of leukemia is often nicknamed the "Leukemia Cure". For CML, the only curative treatment option is allogeneic HSCT.

Anonymous Patient Answer

Does leukemia, myeloid, acute run in families?

Leukemia, myeloid and acute family history was associated with an increased risk of leukemic disease, and acute leukemias and chronic lymphocytic leukemia more frequently in relatives of a patient with acute myeloid leukemia.

Anonymous Patient Answer

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

Overall, leukemia shows up in blood work in ages of 24-28 (male), 24-26 and 29-36 for female. Myeloid leukemias show up in patients in the range of 30-34 and in females. Acute leukemia showed up almost continuously in ages of 16-18 and 36-37 years for males. There may actually be small age variations in each of the leukemia groups. The total mean age for each type of leukemia shows that leukemia is still rare at ages 10 and 65. On average, most patients are seen at ages 10 and 65. The mean age for myeloid leukemia is about 4 years later than leukemia in its peak age group.

Anonymous Patient Answer

Is venetoclax safe for people?

A very small number of people experienced elevated liver enzymes when taking venetoclax, although they had none of the common side effect of elevated transaminases. To date, it has never been identified as a cause for a clinical reaction. Additional safety tests were not conducted in this study. [No data on the clinical usefulness was reported].

Anonymous Patient Answer

Has venetoclax proven to be more effective than a placebo?

While venetoclax failed to improve response rates or increase progression-free survival in the first-line treatment of adults with myeloid leukemia, it did reduce the rate of discontinuation due to toxicity in this trial. These data must be interpreted cautiously in view of the small number of subjects enrolled in this study.

Anonymous Patient Answer

Is venetoclax typically used in combination with any other treatments?

[Power(http://www.withpower.co/d/leukemia-clinical-trials) Venetoclax is typically used in combination with other treatments in B-cell malignancies, including lymphoblastic lymphoma. The most common combination partners for venetoclax are cyclophosphamide, cisplatin and doxorubicin.] [Power(http://www.withpower.co/d/lymphoma-clinical-trials) Venetoclax is used in combination with chemotherapy in a number of types of the aggressive cancers lymphoma. [Power(http://www.withpower.

Anonymous Patient Answer

What are the chances of developing leukemia, myeloid, acute?

Given the elevated risk of leukemia after a history of acute myeloid leukemia, it is prudent to monitor your risk of developing leukemias following treatment, and it is important for patients to report any symptoms of leukemia within 2 months of initiating therapy so a baseline complete blood count can be obtained. The risk factors for development of leukemia following acute myeloid leukemia are mainly clinical and don't appear to be a function of treatment intensity. In fact, these risk factors can be seen in patients treated with lower doses of cytotoxic agents like fludarabine or cladribine.

Anonymous Patient Answer
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