Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Cytarabine

Daunorubicin

Dosing for first induction: CPX-351

• CPX-351 at 100u/m2 will be administered on study days 1, 3 and 5

Dosing for second induction:

• CPX-351 at 100 u/m2 will be administered on days 1 and 3

Dosing for consolidation:

• CPX-351 at 65 u/m2 will be administered on days 1 and 3

Cytarabine:Daunorubicin Liposome Injection

CPX-351

Ellen K Ritchie, MD

This is an open label study to assess the suitability of CPX-351 as first intensive therapy in elderly (age ≥60 years) patients with AML. Patients may have received prior AML treatment with non-intensive regimens, e.g. hypomethylating agents, low dose Ara C or lenolidomide, but may not have received intensive AML treatment with anthracyclines and/or cytarabine prior to enrollment on this trial. The outcome of elderly patients following intensive treatment with CPX-351 will be measured by clinical endpoints for efficacy and safety and by biological/functional response.

Investigator Initiated Trial of CPX-351 for Untreated Acute Myeloid Leukemia

Phase II Trial of CPX (Cytarabine:Daunorubicin) Liposome Injection in Patients >/=60 Years of Age With AML Previously Untreated By Intensive Chemotherapy

Overall survival is measured from the date of registration to death from any cause. Patients not known to have died will be censored on the date they were last known to be alive. Patients were followed for 2.5 years.

The number of patients who achieve response will be divided by the number of patients in the efficacy population to determine response rate.

The Montreal Cognitive Assessment (MOCA) is a 30-point test which assesses several cognitive domains. Possible total scores range from 0 to 30. The results can be interpreted as follows: normal cognition: 26-30 points, mild cognitive impairment: 18-25 points, moderate cognitive impairment: 10-17 points, and severe cognitive impairment: under 10 points.

The Blessed Orientation-Memory-Concentration Test is designed to evaluate older patients for early dementia. Possible total scores range from 0 (all items answered correctly) to 28 (all items answered incorrectly).

Adverse events included neutropenic fever, transient episodes of pericarditis, febrile neutropenia, streptococcus bacteremia, hypotensive episode, severe diffuse cerebral dysfunction, UTI (klebsiella pneumonia), anorexia with malnutrition, hypophosphatemia, hypokalemia, purple macules, elevated ALT, hypoalbuminemia, hyperbilirubinemia, syncope, joint pain, transaminitis, bacteremia, typhlitis, VRE bacteremia, Osteomyelitis, Decreased LVEF, GI adenovirus, Acute kidney injury, pulmonary edema, neutropenia, bronchospasm, bone pain, urinary incontinence, c. difficile infection, mucositis, and vaginal pain.

Jazz Pharmaceuticals

Weill Medical College of Cornell University

Dosing for first induction: CPX-351

• CPX-351 at 100u/m2 will be administered on study days 1, 3 and 5

Dosing for second induction:

• CPX-351 at 100 u/m2 will be administered on days 1 and 3

Dosing for consolidation:

• CPX-351 at 65 u/m2 will be administered on days 1 and 3

CPX-351: Cytarabine:Daunorubicin Liposome Injection

CPX-351 (Cytarabine:Daunorubicin) Injection

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Newly Diagnosed AML Patients Aged ≥ 60 Years

We intended to collect and compare baseline and end of induction data to assess the relationship of cognitive function to treatment response and overall survival, event-free survival, and morphologic leukemia free state. Subjects on treatment were usually too unwell to complete the questionnaires, which resulted in significant missing data. We were unable to determine if the relationship was statistically significant.

Dr. Ellen K. Ritchie

Primary Efficacy

30-Day Mortality Rate

14 subjects were excluded from analysis for this measure due to treatment failure (progressive disease or non-evaluable).

Complete Response Rate (CR, CRp, CRi, and CR+CRp+CRi)

Montreal Cognitive Assessment (baseline)

Montreal Cognitive Assessment (30 days post-treatment)

9 subjects did not complete the MOCA and they were excluded from analysis for this measure.

Change in Relationship of Cognitive Function to Treatment Response and OS, Event-free Survival and Morphologic Leukemia Free State as Measured by the MOCA

Blessed Orientation-Memory-Concentration Test (baseline)

Blessed Orientation-Memory-Concentration Test (30 days post-treatment)

9 subjects did not complete the Blessed Orientation-Memory-Concentration Test and they were excluded from analysis for this measure.

Change in Relationship of Cognitive Function to Treatment Response and OS, Event-free Survival and Morphologic Leukemia Free State as Measured by the Blessed Orientation-Memory-Concentration Test

Spots Global Cancer Trial Database for Investigator Initiated Trial of CPX-351 for Untreated Acute Myeloid Leukemia

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