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Can a lab test predict which chemo works best? new study aims to find out

NCT ID NCT04263181

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether testing cancer cells in a lab can predict how well chemotherapy will work for people with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). Researchers will take blood and bone marrow samples before and during treatment to see if lab results match real patient outcomes. The goal is to make chemotherapy more personalized and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors choose the most effective chemotherapy for each patient with AML or MDS.
What could go wrong
This is an early-stage observational study, not a treatment trial. The lab tests may not accurately predict real-world patient responses.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

80 people

The number who actually took part.

Started

Jan 2020

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

-The study population consists of patients seen at Siteman Cancer Center.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) * Peripheral blood blasts \> 1% * Peripheral white blood cell count \> 1,000/µl. * Age ≥ 18 years * Anticipated treatment with any of the following regimens (Cohort 0) or: * Cohort 1: A standard induction protocol with infusional cytarabine * Cohort 2: Decitabine (either 5-day or 10-day regimens) * Cohort 3: Azacitidine (either intravenous or subcutaneous administration) * Cohort 4: Decitabine (either 5-day or 10-day) + venetoclax * Cohort 5: Azacitidine (either intravenous or subcutaneous administration on 7 day or 5+2+2 schedule) + venetoclax * Patients may receive these therapies as part of other on-going clinical trials or as standard of care treatment. * Patients in Cohort 1 may receive SOC midostaurin or gemtuzumab ozogamicin, provided these start after the Day 2 sample is collected. Patients in Cohort 1 may receive a standard combination of cytarabine/idarubicin, cytarabine/daunorubicin, or Vyxeos, a liposomal formulation of cytarabine and daunorubicin. * ECOG performance status ≤ 3 * Ability to understand and willingness to sign an IRB approved written informed consent document. Exclusion Criteria: * Pregnant or currently nursing * Prior chemotherapy with hypomethylating agents * Known history of positive HIV serology. * Known positive Hepatitis C serology. * Patient must not have received any chemotherapy within 7 days of enrollment, and any acute treatment-related toxicities must have returned to baseline. Patients may have received hydrea as long as they fulfill peripheral blood blast and peripheral WBC inclusion criteria. Prior TKI therapy is allowed, but must be discontinued within 3 days of baseline blood collection. * Currently receiving any other investigational agents.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.