Phase 2
Completed N=75
Dociparstat Sodium (CX-01) Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia
Source: ClinicalTrials.gov NCT02873338 ↗Enrolled (actual)
75
Serious AEs
38.4%
Results posted
Oct 2021
Primary outcomePrimary: Number of Subjects Who Achieved Morphologic Complete Remission — 14; 8; 11 Participants
Summary
This was an exploratory Phase 2, open label, randomized, multicenter, parallel group study to determine whether there was evidence that the addition of dociparstat (CX-01) at 2 different does levels to standard induction therapy (cytarabine+idarubicin, "7+3") and consolidation therapy had an additive therapeutic effect for subjects newly diagnosed with acute myeloid leukemia (AML) when compared with subjects receiving standard induction chemotherapy alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Achieved Morphologic Complete Remission |
14; 8; 11 | — |
| SECONDARY Duration of Event-free Survival |
243.5; 1; 171.5 | — |
| SECONDARY Time to Leukemia-free Survival |
292; 448; 166 | — |
| SECONDARY Number of Subjects Who Achieved Overall Survival |
14; 14; 9; 12; 11; 15 | — |
| SECONDARY Number of Subjects Who Achieved Composite Complete Remission |
16; 9; 15 | — |
| SECONDARY Duration of Morphologic Complete Remission |
233; 494; 294 | — |
| SECONDARY Time to Recovery of Neutrophils |
32; 43; 29; 37; 42; 35 | — |
| SECONDARY Time to Platelet Recovery |
35; 36; 29; 38; 50; 32 | — |
| SECONDARY Number of Subjects Who Died by Day 30 |
2; 1; 3 | — |
| SECONDARY Number of Subjects Who Died by Day 60. |
2; 2; 3 | — |
| SECONDARY Number of Subjects Who Died by Day 90 |
2; 3; 3 | — |
Eligibility Criteria
Inclusion Criteria
Subjects had to meet all the following criteria to be eligible for enrollment in this study:
- Had newly diagnosed, de novo or secondary, previously untreated acute myeloid leukemia (AML).
- Had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Exclusion Criteria
Subjects who met any of the following criteria were not eligible for enrollment in this study:
- Had acute promyelocytic leukemia
- Had prior chemotherapy for AML.
- Had prior intensive chemotherapy or stem cell transplantation for the treatment of myelodysplastic syndrome.
- Had central nervous system (CNS) leukemia.
Data sourced from ClinicalTrials.gov (NCT02873338). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.