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NCT02044796 · ClinicalTrials.gov registry record · Phase 1
Filgrastim, Cladribine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes
A Phase 1 study of Recurrent Adult Acute Myeloid Leukemia and Secondary Acute Myeloid Leukemia, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 199
- Enrollment target
- 1
- Study location
NCT02044796: Completed Phase 1 study of Recurrent Adult Acute Myeloid Leukemia and Secondary Acute Myeloid Leukemia, sponsored by Fred Hutchinson Cancer Center.
NCT02044796 is a Phase 1 study of Recurrent Adult Acute Myeloid Leukemia and Secondary Acute Myeloid Leukemia that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 199 participants, above the 44-participant average among 19 other Recurrent Adult Acute Myeloid Leukemia trials with a reported enrollment target (352% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02044796, a Phase 1 study of Recurrent Adult Acute Myeloid Leukemia and Secondary Acute Myeloid Leukemia, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 199 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the side effects and best dose of mitoxantrone hydrochloride when given together with filgrastim, cladribine, and cytarabine and to see how well they work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndromes that is newly diagnosed, has returned, or does not respond to treatment. Drugs used in chemotherapy, such as filgrastim, cladribine, cytarabine, and mitoxantrone hydrochloride, 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.
Primary Outcome
Defined as the highest dose studied in which the incidence of dose-limiting toxicity is \< 33%, graded according to NCI Common Terminology Criteria for Adverse Events version 4.0
Conditions Studied
Interventions
- DRUG Cladribine
- OTHER Laboratory Biomarker Analysis
- DRUG Cytarabine
- BIOLOGICAL Filgrastim
- DRUG Mitoxantrone Hydrochloride
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2014-01-23 |
| Est. Completion | 2018-04-16 |
| Phase | Phase 1 |
What the finished NCT02044796 record still lists
NCT02044796 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, above the 44-participant average among 19 other Recurrent Adult Acute Myeloid Leukemia trials with a reported enrollment target (352% higher).
The record links to 6 conditions, with Recurrent Adult Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cladribine is the first listed.
NCT02044796 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT02044796 about?
NCT02044796 is a clinical study titled "Filgrastim, Cladribine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes". This phase I/II trial studies the side effects and best dose of mitoxantrone hydrochloride when given together with filgrastim, cladribine, and cytarabine and to see how well they work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndromes that is newly diagnosed, ha...
What is the current status of trial NCT02044796?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 199 participants. The study started on 2014-01-23. Estimated completion is 2018-04-16.
What conditions does trial NCT02044796 study?
This clinical trial studies the following conditions: Recurrent Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Acute Biphenotypic Leukemia, Untreated Adult Acute Myeloid Leukemia, Previously Treated Myelodysplastic Syndrome.
What interventions are being tested in trial NCT02044796?
The interventions under investigation include: Cladribine (DRUG), Laboratory Biomarker Analysis (OTHER), Cytarabine (DRUG), Filgrastim (BIOLOGICAL), Mitoxantrone Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT02044796?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02044796 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02044796's enrollment target sits among peer trials
199 1st of 19 higher than 19 of 19 other Recurrent Adult Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Adult Acute Myeloid Leukemia 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.
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