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NCT02642965 · ClinicalTrials.gov registry record · Phase 1
Liposome-encapsulated Daunorubicin-Cytarabine, Fludarabine Phosphate, Cytarabine, and Filgrastim in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT02642965: Completed Phase 1 study, sponsored by Children's Oncology Group.
NCT02642965 is a Phase 1 study that has completed, run by Children's Oncology Group. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02642965, a Phase 1 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dose of liposome-encapsulated daunorubicin-cytarabine when given with fludarabine phosphate, cytarabine, and filgrastim and to see how well they work in treating younger patients with acute myeloid leukemia that has come back after treatment (relapsed) or is not responding to treatment (is refractory). Liposome-encapsulated daunorubicin-cytarabine is made up of two chemotherapy drugs, cytarabine and daunorubicin hydrochloride, and works to stop cancer cell growth by blocking the cells from dividing. Drugs used in chemotherapy, such as fludarabine phosphate and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Filgrastim may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy. Giving liposome-encapsulated daunorubicin-cytarabine followed by fludarabine phosphate, cytarabine, and filgrastim may be a better treatment for patients with relapsed acute myeloid leukemia and may cause fewer side effects to the heart, a common effect of other chemotherapy treatments for acute myeloid leukemia.
Primary Outcome
Number of patients in the dose-finding phase with a dose-limiting toxicity, graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Cytarabine
- BIOLOGICAL Filgrastim
- DRUG Liposome-encapsulated Daunorubicin-Cytarabine
- DRUG Fludarabine Phosphate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2016-05-02 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 1 |
What the finished NCT02642965 record still lists
NCT02642965 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02642965 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02642965 about?
NCT02642965 is a clinical study titled "Liposome-encapsulated Daunorubicin-Cytarabine, Fludarabine Phosphate, Cytarabine, and Filgrastim in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia". This phase I/II trial studies the side effects and best dose of liposome-encapsulated daunorubicin-cytarabine when given with fludarabine phosphate, cytarabine, and filgrastim and to see how well they work in treating younger patients with acute myeloid leukemia that has come back after treatment (r...
What is the current status of trial NCT02642965?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2016-05-02. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT02642965?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Cytarabine (DRUG), Filgrastim (BIOLOGICAL), Liposome-encapsulated Daunorubicin-Cytarabine (DRUG), Fludarabine Phosphate (DRUG).
Who is sponsoring clinical trial NCT02642965?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02642965's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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