RecruitingPhase 2NCT03629171

Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia

Phase II Study of CPX-351 in Combination With Venetoclax in Patients With Acute Myeloid Leukemia (AML)


Sponsor

M.D. Anderson Cancer Center

Enrollment

52 participants

Start Date

Oct 29, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies how well liposome-encapsulated daunorubicin-cytarabine and venetoclax work in treating participants with acute myeloid leukemia that has come back (relapsed), does not respond to treatment (refractory), or has not been treated (untreated). Drugs used in chemotherapy, such as liposome-encapsulated daunorubicin-cytarabine and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of two cancer drugs — a liposomal chemotherapy (CPX-351, a special version of daunorubicin and cytarabine packaged for better delivery) and venetoclax (a targeted drug that helps cancer cells self-destruct) — for people with acute myeloid leukemia (AML), a type of blood cancer. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with acute myeloid leukemia (AML) - For the relapsed/refractory group (cohort A): your AML has come back or stopped responding to prior treatment - For the newly diagnosed group (cohort B): you are 18–69 years old and have received no prior AML treatment **You may NOT be eligible if...** - You have a serious active infection - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding - You have a leukemia type that requires a different treatment approach (like APL) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLiposome-encapsulated Daunorubicin-Cytarabine

Given IV

DRUGVenetoclax

Given PO


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT03629171


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