CLINICAL TRIAL

Laboratory Biomarker Analysis for Leukemia, Myeloid, Acute

1 Prior Treatment
High Risk
Relapsed
Waitlist Available · 18+ · All Sexes · Houston, TX

This study is evaluating whether a drug may help prevent cancer from returning in individuals who have had cancer in the past.

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About the trial for Leukemia, Myeloid, Acute

Eligible Conditions
Leukemia, Myeloid, Acute · Leukemia, Myeloid · Therapy-Related Myeloid Neoplasm · Leukemia · Adult Acute Myeloid Leukemia in Remission · Myelodysplastic Syndromes · Blasts Under 10 Percent of Bone Marrow Nucleated Cells · Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome

Treatment Groups

This trial involves 2 different treatments. Laboratory Biomarker Analysis is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Laboratory Biomarker Analysis
OTHER
Nivolumab
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Leukemia, Myeloid, Acute or one of the other 7 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:
High risk for relapse defined as: 1st CR with high risk features for relapse (including history of prior malignancy treated with chemotherapy or radiotherapy, or history of myelodysplastic syndrome, myeloproliferative disorder, chronic myelomonocytic leukemia, myelodysplastic syndrome [MDS]/myeloproliferative neoplasm [MPN] or other hematologic malignancy thought to have evolved to AML [i.e., secondary AML, (sAML)]; high risk cytogenetics at diagnosis; fms-related tyrosine kinase 3 [FLT3] mutated at diagnosis; or presence or minimal residual disease assessed by polymerase chain reaction [PCR], cytogenetics, and/or flow cytometry at time of enrollment) 2nd CR regardless of disease characteristics at the time of diagnosis
No further chemotherapy or stem cell transplant (SCT) planned at the time of enrollment
Creatinine =< 1.5 x upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (b-hCG) pregnancy test result within 24 hours prior to the first dose of treatment and must agree to use an effective contraception method during the study and for 23 weeks after the last dose of the study drug; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 31 weeks following the last dose of study drug
Patients with AML in remission (defined as CR, CR with incomplete platelet recovery -CRp-, CR with incomplete hematologic recovery -CRi-, or partial remission defined as a bone marrow with < 10% blasts after therapy with or without hematologic recovery)
Have received induction chemotherapy and at least one cycle of consolidation chemotherapy; patients should have achieved a CR within 12 months of enrollment onto protocol
Serum bilirubin =< 1.5 x ULN
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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: 6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 months.
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 Laboratory Biomarker Analysis will improve 1 primary outcome and 5 secondary outcomes in patients with Leukemia, Myeloid, Acute. Measurement will happen over the course of Up to 30 days post-treatment.

Immunologic responses to nivolumab among patients with acute myeloid leukemia (AML) in complete remission (CR) status post standard chemotherapy
UP TO 30 DAYS POST-TREATMENT
UP TO 30 DAYS POST-TREATMENT
Incidence of toxicity among patients with acute myeloid leukemia (AML) in complete remission (CR)
UP TO 30 DAYS POST-TREATMENT
UP TO 30 DAYS POST-TREATMENT
Changes in minimal residual disease (MRD) during therapy with nivolumab, assessed by flow cytometry
UP TO 30 DAYS POST-TREATMENT
Assessed as a predictor of response to immune therapy in treatment of AML.
UP TO 30 DAYS POST-TREATMENT
Overall survival
UP TO 30 DAYS POST-TREATMENT
UP TO 30 DAYS POST-TREATMENT
Time to relapse
UP TO 30 DAYS POST-TREATMENT
UP TO 30 DAYS POST-TREATMENT
Recurrence-free survival rate
6 MONTHS
6 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.

Can leukemia, myeloid, acute be cured?

The current data demonstrate that acute leukemia can be cured with the currently available treatments and these findings offer the potential to improve current therapeutic regimes. However, the data require confirmation in larger, multicenter studies and on the most appropriate and sensitive assay systems.

Anonymous Patient Answer

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

Although all age groups are exposed to ATLL during their lifetime, a disproportionately high number of ATLL cases occur in children ages 5 to 9 year, and young adults and older adults. Furthermore, the number of ATLL cases in the US increases annually.

Anonymous Patient Answer

What causes leukemia, myeloid, acute?

[Signs and symptoms include the following: bleeding (bruising) in joints, swollen lymph nodes under the arms and under the neck, feeling tired, and hair loss.[Power(http://www.withpower.com/clinical-trials/leukemia, myeloid, acute) make it easy to find leukemia clinical trials tailored to your condition, treatment, or location.

Anonymous Patient Answer

What are the signs of leukemia, myeloid, acute?

The presenting signs of leukemia, myeloid, acute are similar, and include symptoms such as weight loss, fever, and a pale appearance. For other types of leukemia, signs such as a fast heart rate and increased white blood cells are present.

Anonymous Patient Answer

What are common treatments for leukemia, myeloid, acute?

There are several common treatments for acute leukemia, myeloid, acute. Most are administered to relieve both the symptoms and side effects caused by the disease. Although most patients with acute leukemia will survive the course of the disease, they may require multiple treatments to achieve remission and long-term wellness.

Anonymous Patient Answer

What is leukemia, myeloid, acute?

Leukemia, myeloid, acute, is when the bone marrow fails to reproduce blood and platelets fast enough. It is characterised by an increased number of white blood cells from another part of the body or in the bloodstream, the enlargement and damage of white blood cells, not enough blood platelets, and sometimes an increased number of white blood cells and platelets.\n

Anonymous Patient Answer

What is the primary cause of leukemia, myeloid, acute?

Most cases of leukemia, myeloid, acute were caused by some combination of genetic alterations leading to an altered growth rate, cell death, or cellular differentiation. The combination of mutations occurring in the same cell, a clone, is termed clonal hematopoiesis. Most cases were in adults or children; however, leukemias caused by other processes are encountered in the general population as well.

Anonymous Patient Answer

How quickly does leukemia, myeloid, acute spread?

Patients with AL (99) had a mean duration of symptoms of 42 days, compared with 26 days for patients with AM (61). The frequency of B-symptoms was greater for patients with ALL (80%) than those with AML (40%). The rate of AL (11) was similar to AML (6). The median duration of symptoms for the AL patients (20) was significantly shorter than for the AML (39) patients. The frequency of symptoms also was significantly greater for the AL population (75%) than for the AML (31%) patients. Patients with AL (99) were similar to those with AML (61) in all parameters.

Anonymous Patient Answer

What are the latest developments in nivolumab for therapeutic use?

Since this drug received'Breakthrough'status, further development seems imminent. However, the clinical use of the antibody remains in the experimental area, and thus, at present, no data to support its use in patients have been released. An analysis combining clinical data from previous studies show that patients with solid tumors, such as mesothelioma and renal cell carcinoma, display an improved outcome both in terms of survival and in PFS. The effect on OS remains to be clarified. More data on the response rate and the pharmacokinetics will be necessary.

Anonymous Patient Answer

Have there been any new discoveries for treating leukemia, myeloid, acute?

We can't only tell you about the studies that show a positive outcome but we can also show the studies that weren't as effective, but we can tell you that we have made strides in the treatment of leukemia and other chronic illnesses. In order to get into these developments, you need to have a connection like you did with [PowerMD] and [Lucky Number Sizes]. So if you're out there looking for studies, let us know so that we can point you to the studies that're going on all the time and that're being published.

Anonymous Patient Answer

What are the common side effects of nivolumab?

Non-life-threatening and common side effects associated with this drug in Phase III studies were fatigue, constipation, urinary infection, nausea, and vomiting. The most common rash occurring in more than 11% of patients treated with nivolumab was acne, itch, stomatitis, and phalenitis. Other common side effects included: decreased appetite, decreased weight, headache, dizziness, and asthenia.

Anonymous Patient Answer

Does leukemia, myeloid, acute run in families?

In a recent study, findings does not support a statistical association between AML disease in parents and AML in children. We will now use these data to conduct a second-parent-discordant case-control study, in which we will assess this association by controlling for other environmental factors. In a recent study, findings can have important ramifications for counseling patients with AML regarding treatment options.

Anonymous Patient Answer
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