60 and older, any sex, with Adult Acute Erythroid Leukemia (M6) or Adult Acute Megakaryoblastic Leukemia (M7). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Response Rate (RR)Primary· Day 42
The response rate was determined as the sum of complete response calculated by adding the total complete response (CR) and complete response with incomplete count recovery (CRi). The outcome is reported as the total number without dispersion.
* CR = less than 5% blasts; no blasts with auer rods; and no persistence of extramedullary disease, with blood count recovery to platelets ≥ 100,000/uL and ANC \> 1000/uL, with transfusion independence.
* CRi = all the parameters for CR, but platelets \< 100,000/uL and/or ANC ≤ 1000/uL.
Group
Value
95% CI
Liposomal Cytarabine-daunorubicin CPX-351
3
Complete Response With Incomplete Count Recovery (CRi)Secondary· Day 42
Complete response (CR) with incomplete count recovery (CRi) was determined as the number of participants who achieved CRi after induction therapy. The outcome is reported as the total number or participants without dispersion.
* CR = less than 5% blasts; no blasts with auer rods; and no persistence of extramedullary disease, with blood count recovery to platelets ≥ 100,000/uL and ANC \> 1000/uL, with transfusion independence.
* CRi = all the parameters for CR, but platelets \< 100,000/uL and/or ANC ≤ 1000/uL.
Group
Value
95% CI
Liposomal Cytarabine-daunorubicin CPX-351
1
Complete Response (CR)Secondary· Day 42
Complete response (CR) was determined the number of participants who achieved CR by Day 42 after induction treatment. The outcome is reported as the total number of participants without dispersion.
• CR = less than 5% blasts; no blasts with auer rods; and no persistence of extramedullary disease, with blood count recovery to platelets ≥ 100,000/uL and ANC \> 1000/uL, with transfusion independence.
Group
Value
95% CI
Liposomal Cytarabine-daunorubicin CPX-351
2
Duration of Remission (DOR) Following Induction With CPX-351Secondary· Up to 1 year
Duration of remission (DOR) was assessed as the length of time from documented complete response (CR) or complete response with incomplete count recovery (CRi) until documented lost of response, relapse, or death. The outcome is reported as the median with full range.
* CR = less than 5% blasts; no blasts with auer rods; and no persistence of extramedullary disease, with blood count recovery to platelets ≥ 100,000/uL and ANC \> 1000/uL, with transfusion independence.
* CRi = all the parameters for CR, but platelets \< 100,000/uL and/or ANC ≤ 1000/uL.
For patients remaining alive, duration of
Group
Value
95% CI
Liposomal Cytarabine-daunorubicin CPX-351
185
25 – 329
Overall Survival (OS)Secondary· At 12 months
Overall survival (OS) was assessed as the number of participants remaining alive 12 months, starting from date of entry into trial. The outcome is reported as the number of participants (without dispersion).
Group
Value
95% CI
Liposomal Cytarabine-daunorubicin CPX-351
1
Early Induction Mortality (Day 30 After 1st Induction)Secondary· 30 days
Early induction mortality was assessed as the number of participants who died within 30 days of completing the 1st cycle of CPX-351 (1st induction). The outcome is reported as the number of participants without dispersion.
Group
Value
95% CI
Liposomal Cytarabine-daunorubicin CPX-351
2
Mortality at Day 60 After 1st InductionSecondary· 60 days
Mortality at Day 60 after 1st induction was assessed as the number of participants who died within 60 days of completing the 1st cycle of CPX-351 (1st induction). The outcome is reported as the number of participants without dispersion.
Group
Value
95% CI
Liposomal Cytarabine-daunorubicin CPX-351
3
Participants Experiencing of Serious Adverse EventsSecondary· Up to 4 weeks after completion of treatment
Serious adverse events per participant were assessed as serious adverse events per 21CFR§312.32 that were Grade 3 or greater, and independent of relationship to CPX-351. The outcome is reported as the number of participants that experienced any defined SAE, a number without dispersion.
Group
Value
95% CI
Liposomal Cytarabine-daunorubicin CPX-351
5
Serious Adverse EventsSecondary· Up to 4 weeks after completion of treatment
Serious adverse events were assessed as serious adverse events per 21CFR§312.32 that were Grade 3 or greater, and independent of relationship to CPX-351. The outcome is reported as the total number of the defined SAEs, a number without dispersion.
Group
Value
95% CI
Liposomal Cytarabine-daunorubicin CPX-351
8
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 4 weeks after completion of treatment].
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Liposomal Cytarabine-daunorubicin CPX-351
Serious: 5/11 (45%)
Deaths: 10/11
Serious adverse events (8 terms)
Reaction
System
Liposomal Cytarabine-dauno…
Febrile neutropenia
Blood and lymphatic system disorders
—
Pneumonia
Respiratory, thoracic and mediastinal disorders
—
Adult repiratory distress syndrome (ARDS)
Respiratory, thoracic and mediastinal disorders
—
Cardio-pulmonary arrest
Cardiac disorders
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
Chills
General disorders
—
Anemia
Blood and lymphatic system disorders
—
Neoplasms - Other, Acute myelogenous leukemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Other adverse events (43 terms — click to expand)
Reaction
System
Liposomal Cytarabine-dauno…
Febrile neutropenia
Blood and lymphatic system disorders
—
Diarrhea
Gastrointestinal disorders
—
Mucositis oral
Gastrointestinal disorders
—
Constipation
Gastrointestinal disorders
—
Fever
General disorders
—
Hallucinations
Psychiatric disorders
—
Abdominal pain
Gastrointestinal disorders
—
Colitis
Gastrointestinal disorders
—
Hematuria
Renal and urinary disorders
—
Cough
Respiratory, thoracic and mediastinal disorders
—
Rash
Skin and subcutaneous tissue disorders
—
Thrombotic thrombocytopenic purpura
Blood and lymphatic system disorders
—
Lung infection
Infections and infestations
—
Alanine aminotransferase increased
Investigations
—
Dizziness
Nervous system disorders
—
Blood and lymphatic system disorders, other - clot in cheek
Blood and lymphatic system disorders
—
Atrial fibrillation
Cardiac disorders
—
Cardiac disorders, other - tachycardia
Cardiac disorders
—
Sinus tachycardia
Cardiac disorders
—
Eye disorders, other - eye itching
Eye disorders
—
Papilledema
Eye disorders
—
Nausea
Gastrointestinal disorders
—
Rectal hemorrhage
Gastrointestinal disorders
—
Pain, hip
General disorders
—
Pain, leg
General disorders
—
Fatigue
General disorders
—
Investigations, other - fluid overload
Investigations
—
Hepatobiliary disorders, other - hyperbilirubinemia
Metabolism and nutrition disorders
—
Anorexia (decreased food consumption)
Metabolism and nutrition disorders
—
Hypertriglyceridemia
Metabolism and nutrition disorders
—
Bone pain
Musculoskeletal and connective tissue disorders
—
Musculoskeletal and connective tissue disorder, other - broken leg
Musculoskeletal and connective tissue disorders
—
Brachial plexopathy
Nervous system disorders
—
Headache
Nervous system disorders
—
Peripheral motor neuropathy
Nervous system disorders
—
Renal and urinary disorders, other - urinary discomfort
Renal and urinary disorders
—
Aspiration
Respiratory, thoracic and mediastinal disorders
—
Epistaxis (nose bleed)
Respiratory, thoracic and mediastinal disorders
—
Hypoxia
Respiratory, thoracic and mediastinal disorders
—
Respiratory, thoracic and mediastinal disorders, other - chest tightness
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Rondeep Brar
Last refreshed: 22 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02019069.