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NCT03701308 · ClinicalTrials.gov registry record · Phase 2
Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy
A Phase 2 study of Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 267
- Enrollment target
- 20
- Study locations
NCT03701308: Active Phase 2 study of Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI).
NCT03701308 is a Phase 2 study of Acute Myeloid Leukemia that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 267 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (132% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03701308, a Phase 2 study of Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 267 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II/III trial studies how well daunorubicin and cytarabine with or without uproleselan works in treating older adult patients with acute myeloid leukemia receiving intensive induction chemotherapy. Drugs used in chemotherapy, such as daunorubicin 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. Uproleselan may prevent cancer from returning or getting worse. Giving daunorubicin and cytarabine with uproleselan may work better in treating patients with acute myeloid leukemia compared to daunorubicin and cytarabine alone.
Primary Outcome
EFS is defined as the time from the date of randomization to the first of failure to achieve a complete remission (CR)/ CR with incomplete blood count recovery (CRi) during induction, relapse, or death due to any cause, with patients last known to be alive and event-free censored at the date of last contact.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- DRUG Cytarabine
- DRUG Daunorubicin
Study Locations (20)
Idaho
- Saint Alphonsus Cancer Care Center-Boise - Boise
- Saint Luke's Cancer Institute - Boise - Boise
- Saint Alphonsus Cancer Care Center-Caldwell - Caldwell
- Kootenai Health - Coeur d'Alene - Coeur d'Alene
- Walter Knox Memorial Hospital - Emmett
- Idaho Urologic Institute-Meridian - Meridian
- Saint Alphonsus Cancer Care Center-Nampa - Nampa
- Kootenai Clinic Cancer Services - Post Falls - Post Falls
- Kootenai Clinic Cancer Services - Sandpoint - Sandpoint
California
- Community Cancer Institute - Clovis
- UC San Diego Moores Cancer Center - La Jolla
- Loma Linda University Medical Center - Loma Linda
- Cedars Sinai Medical Center - Los Angeles
Delaware
- Delaware Clinical and Laboratory Physicians PA - Newark
- Helen F Graham Cancer Center - Newark
- Medical Oncology Hematology Consultants PA - Newark
- Christiana Care Health System-Christiana Hospital - Newark
Connecticut
- Smilow Cancer Hospital Care Center at Saint Francis - Hartford
- Yale University - New Haven
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 267 participants |
| Start Date | 2019-03-28 |
| Est. Completion | 2026-10-26 |
| Phase | Phase 2 |
What the registry record for NCT03701308 still lists
NCT03701308 is an interventional study that assigns participants to a tested intervention. The registered 267 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (132% higher).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT03701308 names 20 study sites across 5 states, led by Idaho, California, Delaware.
Frequently Asked Questions
What is clinical trial NCT03701308 about?
NCT03701308 is a clinical study titled "Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy". This phase II/III trial studies how well daunorubicin and cytarabine with or without uproleselan works in treating older adult patients with acute myeloid leukemia receiving intensive induction chemotherapy. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to s...
What is the current status of trial NCT03701308?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 267 participants. The study started on 2019-03-28. Estimated completion is 2026-10-26.
What conditions does trial NCT03701308 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT03701308?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Cytarabine (DRUG), Daunorubicin (DRUG).
Who is sponsoring clinical trial NCT03701308?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03701308 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, Delaware, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Myeloid Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03701308's enrollment target sits among peer trials
267 31st of 306 higher than 276 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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