CPX-351 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Completed · Phase 2

Conditions studied: Adult Acute Erythroid Leukemia (M6), Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia and Acute Monocytic Leukemia (M5), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes

In brief

This phase 2 clinical trial studies how well CPX-351 (liposomal cytarabine-daunorubicin) works in treating patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome. Drugs used in chemotherapy, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

Key facts

Study ID

NCT02019069

Run by

Rondeep Brar

People needed

11

Starts

2014-02-03

Expected to finish

2017-12-18

Last updated by the study team

2019-01-22

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to understand and voluntarily give informed consent
• Age ≥ 60
• Pathological diagnosis of AML (by WHO criteria) or higher risk MDS (includes int-2 and high risk MDS by IPSS) along with one of the following:
• Patients with de novo or secondary MDS with progression/refractoriness after HMA treatment who have not transformed to AML
• Patients with MDS and prior HMA treatment for MDS who transform to AML
• Patients with AML who are refractory/relapsed after HMA therapy for their AML are eligible
• Life expectancy > 1 month
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Able to adhere to the study visit schedule and other protocol requirements
• Laboratory values fulfilling the following:
• Serum creatinine < 2.0 mg/dL
• Serum total bilirubin ≤ 2.5 mg/dL. Note, patients with Gilbert's syndrome may have elevated bilirubin at baseline prior to diagnosis with AML or MDS. Patients with Gilbert's syndrome are included if their total bilirubin is ≤ 2 times their baseline total bilirubin.
• Serum alanine aminotransferase or aspartate aminotransferase < 3 times ULN
• Cardiac ejection fraction ≥ 45% by echocardiography (transthoracic echocardiography) or MUGA scan
• Patients with second malignancies may be eligible at discretion of PI given acute life threatening nature of untreated AML or higher risk MDS. Patients maintained on long-term non-chemotherapy treatment, e.g., hormonal therapy, are also eligible.

You may not qualify if…

• Patients who have previously undergone allogeneic hematopoietic stem cell transplant will be excluded from this study
• Patients who have previously had > 368 mg/m2 cumulative dose of daunorubicin or > 368 mg/m2 daunorubicin-equivalent anthracycline therapy (for example, from prior treatment of solid tumors). See appendix for anthracycline equivalence table.
• Acute promyelocytic leukemia [t(15;17)]
• Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent
• Patients who have had conventional intensive cytotoxic induction chemotherapy for treatment of specifically MDS or AML are excluded.
• Patients who have not previously been treated with HMA therapy will be excluded
• Clinical evidence of active CNS leukemia
• Patients with evidence of uncontrolled current myocardial impairment (e.g. unstable ischemic heart disease, uncontrolled arrhythmia, symptomatic valvular dysfunction not controlled on medical therapy, uncontrolled hypertensive heart disease, and uncontrolled congestive heart failure)
• Active and uncontrolled infection. Patients with an active infection receiving treatment and hemodynamically stable for 48 hours may be entered into the study
• Known active uncontrolled HIV or hepatitis C infection
• Known hypersensitivity to cytarabine, daunorubicin or liposomal products
• Known history of Wilson's disease or other copper-related disorders
• Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient's safety or interfere with data interpretation
• Laboratory abnormalities:
• Serum creatinine ≥ 2.0 mg/dL
• Serum total bilirubin > 2.5 mg/dL. Note, patients with Gilbert's syndrome may have elevated bilirubin at baseline prior to diagnosis with AML or MDS. Patients with Gilbert's syndrome are excluded if their total bilirubin is > 2 times their baseline total bilirubin.
• Serum alanine aminotransferase or aspartate aminotransferase > 3 times ULN

Where it is running

• Stanford University, School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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