RecruitingPhase 1NCT03896269

CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Phase 1 Dose Escalation Study of CPX-351 for Patients With Int-2 or High Risk IPSS Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia After Failure to Hypomethylating Agents


Sponsor

M.D. Anderson Cancer Center

Enrollment

38 participants

Start Date

May 14, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial studies best dose and side effects of liposome-encapsulated daunorubicin-cytarabine (CPX-351) and how well it works in treating patients with high risk myelodysplastic syndrome or chronic myelomonocytic leukemia that has come back or has not responded to treatment. Drugs used in chemotherapy, such as liposome-encapsulated daunorubicin-cytarabine, 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 study is testing a drug called CPX-351 — a special formulation that packages two chemotherapy drugs together — in patients with high-risk myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) that has not responded to or relapsed after standard treatment. **You may be eligible if...** - You have been diagnosed with MDS or CMML by standard World Health Organization criteria - Your disease did not respond to at least 4 cycles of standard treatment (azacitidine, decitabine, or related drugs) or has relapsed after initial improvement - Your disease is classified as intermediate-2 or high risk with more than 5% abnormal cells (blasts) in the bone marrow - You are either ineligible for or have chosen not to pursue a stem cell transplant **You may NOT be eligible if...** - You have a condition preventing safe administration of chemotherapy - You have certain active infections or significant organ dysfunction - You are pregnant or breastfeeding 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


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT03896269


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