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NCT02286726 · ClinicalTrials.gov registry record · Phase 2
CPX-351 in Treating Patients With Newly Diagnosed, High-Risk Acute Myeloid Leukemia
A Phase 2 study of Acute Myeloid Leukemia and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT02286726: Completed Phase 2 study of Acute Myeloid Leukemia and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, sponsored by M.D. Anderson Cancer Center.
NCT02286726 is a Phase 2 study of Acute Myeloid Leukemia and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 56 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (52% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02286726, a Phase 2 study of Acute Myeloid Leukemia and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the best dose and how well liposomal cytarabine-daunorubicin CPX-351 (CPX-351) works in treating patients with newly diagnosed acute myeloid leukemia and who are at risk for not responding well to treatment. Liposomal cytarabine-daunorubicin CPX-351 combines two chemotherapy drugs that are known to help each other work better, and may work to stop the growth of cancer cells by blocking the cells from dividing.
Primary Outcome
Response is defined as Complete response (CR) or CR with incomplete blood count recovery (CRi) rate: Complete Remission (CR) is Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0 x 10\^9/L (1000/μL); platelet count \>100 x 10\^9/L (100,000/μL). Complete Response with incomplete blood count recovery (CRi) is All CR criteria except for residual neutropenia (\<1.0 x 10\^9/L \[1000/μL\]) and/or thrombocytopenia (\<100 x 10\^9
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Liposome-encapsulated Daunorubicin-Cytarabine
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2015-05-04 |
| Est. Completion | 2020-01-22 |
| Phase | Phase 2 |
What the finished NCT02286726 record still lists
NCT02286726 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (52% lower).
The record links to 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02286726 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02286726 about?
NCT02286726 is a clinical study titled "CPX-351 in Treating Patients With Newly Diagnosed, High-Risk Acute Myeloid Leukemia". This phase II trial studies the best dose and how well liposomal cytarabine-daunorubicin CPX-351 (CPX-351) works in treating patients with newly diagnosed acute myeloid leukemia and who are at risk for not responding well to treatment. Liposomal cytarabine-daunorubicin CPX-351 combines two chemother...
What is the current status of trial NCT02286726?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2015-05-04. Estimated completion is 2020-01-22.
What conditions does trial NCT02286726 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Secondary Acute Myeloid Leukemia.
What interventions are being tested in trial NCT02286726?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Liposome-encapsulated Daunorubicin-Cytarabine (DRUG).
Who is sponsoring clinical trial NCT02286726?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02286726 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02286726's enrollment target sits among peer trials
56 130th of 306 higher than 176 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
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