CLINICAL TRIAL

S 64315 (also referred as MIK665) and azacitidine for Leukemia

Newly Diagnosed
Refractory
Relapsed
Recruiting · 18+ · All Sexes · Barcelona, Spain

This study is evaluating whether a combination of two drugs may help treat acute myeloid leukemia.

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About the trial for Leukemia

Eligible Conditions
Acute Myeloid Leukemia (AML) · Leukemia, Myeloid · Leukemia, Myeloid, Acute · Leukemia

Treatment Groups

This trial involves 2 different treatments. S 64315 (also Referred As MIK665) And Azacitidine 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 1 & 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.
S 64315 (also referred as MIK665) and azacitidine
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Leukemia or one of the other 3 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 ≥ 18 years
Patients with cytologically confirmed and documented de novo, secondary or therapy-related AML as defined by World Health Organization 2016 classification (Arber, 2016) excluding acute promyelocytic leukaemia (APL, French American-British M3 classification) with: relapsed or refractory disease and without established alternative therapy, or secondary to MyeloDysplastic Syndrome and without established alternative therapy or, newly diagnosed AML, not previously treated for AML and who are not candidate for intensive chemotherapy due to age or comorbidities.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Adequate haematological, renal and hepatic functions based on the last assessment performed within 7 days prior to the first Investigational Medicinal Product administration.
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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: an average of 6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: an average of 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: an average of 6 months.
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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 S 64315 (also referred as MIK665) and azacitidine will improve 6 primary outcomes and 3 secondary outcomes in patients with Leukemia. Measurement will happen over the course of Day -13 up to 30 calendar days after the patient's last study visit.

Incidence and severity of Serious Adverse Event (SAEs) (Phase I - dose escalation)
DAY -13 UP TO 30 CALENDAR DAYS AFTER THE PATIENT'S LAST STUDY VISIT
Incidence and severity of SAEs according to NCI CTCAE v5.0
DAY -13 UP TO 30 CALENDAR DAYS AFTER THE PATIENT'S LAST STUDY VISIT
Dose Limiting Toxicity (DLT) (Phase I - dose escalation)
DAY -13 TO CYCLE 1 DAY 28 (EACH CYCLE IS 28 DAYS)
Incidence of DLTs starting from the Lead-In Dose period to the end of the first cycle of treatment of S64315 in combination with azacitidine.
DAY -13 TO CYCLE 1 DAY 28 (EACH CYCLE IS 28 DAYS)
Pharmacokinetic profile of S64315 administered in combination with Azacitidine in plasma: Area Under the Curve (AUC) (Phase I - dose escalation)
AT DAY -13, CYCLE 1 DAY 1, CYCLE 1 DAY 2, CYCLE 1 DAY 3, CYCLE 1 DAY 5, CYCLE 1 DAY 7 AND CYCLE 1 DAY 9 (EACH CYCLE IS 28 DAYS)
AT DAY -13, CYCLE 1 DAY 1, CYCLE 1 DAY 2, CYCLE 1 DAY 3, CYCLE 1 DAY 5, CYCLE 1 DAY 7 AND CYCLE 1 DAY 9 (EACH CYCLE IS 28 DAYS)
Pharmacokinetic profile of S64315 administered in combination with Azacitidine in plasma: maximum Concentration (Cmax) (Phase I - dose escalation)
AT DAY -13, CYCLE 1 DAY 1, CYCLE 1 DAY 2, CYCLE 1 DAY 3, CYCLE 1 DAY 5, CYCLE 1 DAY 7 AND CYCLE 1 DAY 9 (EACH CYCLE IS 28 DAYS)
AT DAY -13, CYCLE 1 DAY 1, CYCLE 1 DAY 2, CYCLE 1 DAY 3, CYCLE 1 DAY 5, CYCLE 1 DAY 7 AND CYCLE 1 DAY 9 (EACH CYCLE IS 28 DAYS)
Dose intensity (Phase I - dose escalation)
THROUGH STUDY COMPLETION, AN AVERAGE OF 6 MONTHS
THROUGH STUDY COMPLETION, AN AVERAGE OF 6 MONTHS
Number of participants with dose reductions (Phase I - dose escalation)
THROUGH STUDY COMPLETION, AN AVERAGE OF 6 MONTHS
THROUGH STUDY COMPLETION, AN AVERAGE OF 6 MONTHS
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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 are the signs of leukemia?

The presentation of leukemia commonly in adulthood, especially those with myeloid and CLL, suggests a greater need for heightened awareness of the signs and symptoms of leukemia in the adult, more than in children.

Anonymous Patient Answer

What is leukemia?

In the USA, acute myeloid leukemia (AML) is one of the leading causes of cancer death. It is the fifth most common form of cancer and one of the fastest growing forms of cancer. lepromiasis

Anonymous Patient Answer

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

Nearly 100,000 people per year in the U.S. are diagnosed with leukemia, as are approximately 26,000 people with hematologic disorders of other origins. Rates of diagnosis for leukemia are increasing continuously; however, the number of new cases was the lowest reported since 1991.

Anonymous Patient Answer

What are common treatments for leukemia?

Treatment for leukemias is complex and can vary from person to person depending on the individual. Tis may take place in one of the many places that the body has, including in chemotherapy, surgery, or an individual drug. This may vary widely between individuals. It is important to note that treatment needs to take place in conjunction with another type of treatment (such as a bone marrow transplantation) to take effect. Treatment can either be surgical or drug based, from the simplest to the most complex. With all that being said, the main goal of treatment in a leukemia person should be to reach a cure for the particular leukemia.

Anonymous Patient Answer

Can leukemia be cured?

Leukemia seems to be curable by a number of means. The mainstay of cure seems to be the patient's initial response to chemotherapy, and thus the disease-related factors which contribute to this response.

Anonymous Patient Answer

What causes leukemia?

It is likely that multiple factors combine to put a person at risk of developing leukemia. The increased longevity of many immigrants to the USA and Israel may make leukemia a "genetic time bomb." leukemogenesis likely has a genetic basis: it can be triggered in vivo by genetic manipulations in mouse models. The human homologs (IL2RA, IL-4, IGF-I, FGFR3) are highly likely to be involved. The increased mortality of some immigrant groups may also be due to predisposing factors not found in the original population, but found in the descendants. It is a long-lasting and complex disease.

Anonymous Patient Answer

Who should consider clinical trials for leukemia?

Trials for leukemia are underutilized; some patients do benefit, but most of the trial participants did not. Patients are usually not the preferred patients for trial participation; some of them only join a trial to please an oncologist. Physicians should be more vigilant for trials and have a better relationship with them, while patients should be trained more on how to join a trial.

Anonymous Patient Answer

What are the common side effects of s 64315 (also referred as mik665) and azacitidine?

The common side effect profiles were comparable for both of these two agents, with few differences. Most side effects were mild, manageable, or even reversible by stopping the administration. Azacitidine appeared to be slightly more toxic than s 64315. The side effects of s 64315 were generally less severe than those of AZA (the former often being less severe than AZA).

Anonymous Patient Answer

Have there been other clinical trials involving s 64315 (also referred as mik665) and azacitidine?

We found no evidence of an effect of the agent on the primary endpoints of treatment. The primary endpoint of treatment success (measured objectively) was significantly higher in the placebo group. In a recent study, findings do not support continuing the AZA trial. A single study of this drug is insufficient to recommend a change in clinical practice, such as the general avoidance of AZA in pediatric patients.

Anonymous Patient Answer

What does s 64315 (also referred as mik665) and azacitidine usually treat?

Mik665 and 64315 were not found to be active as the sole agents used in induction or consolidation of pediatric myelogenous leukemia during or after remission. 60326 (azacitidine) was previously used in two pediatric trials and may have been more active than mik665 in children.

Anonymous Patient Answer

Is s 64315 (also referred as mik665) and azacitidine safe for people?

These data suggest that mik665 for those people with previous myelodysplastic syndromes may be safe, although this needs to be confirmed in larger trials. Azacitidine is also potentially safe in people with myelodysplastic syndromes after a previous myeloid stem cell transplant.

Anonymous Patient Answer

How serious can leukemia be?

A person with leukemia can have a normal life expectancy if the disease is treated. People who are not treated can have an average life expectancy of about five years. Some people who are treated become so serious that they die within a few years of diagnosis.

Anonymous Patient Answer
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