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NCT01253070 · ClinicalTrials.gov registry record · Phase 2
Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
A Phase 2 study of Therapy-Related Acute Myeloid Leukemia and Acute Promyelocytic Leukemia With PML-RARA, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
- 20
- Study locations
NCT01253070 is a Phase 2 study of Therapy-Related Acute Myeloid Leukemia and Acute Promyelocytic Leukemia With PML-RARA that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 54 participants, below the 70-participant average among 10 other Therapy-Related Acute Myeloid Leukemia trials with a reported enrollment target (23% lower). The trial reports 20 study locations across 9 states.
The verdict
NCT01253070, a Phase 2 study of Therapy-Related Acute Myeloid Leukemia and Acute Promyelocytic Leukemia With PML-RARA, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well sorafenib tosylate and chemotherapy work in treating older patients with acute myeloid leukemia (AML). Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as daunorubicin hydrochloride and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving sorafenib tosylate and combination chemotherapy may be an effective treatment for AML.
Conditions Studied
Interventions
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Biopsy
- OTHER Laboratory Biomarker Analysis
- DRUG Cytarabine
- DRUG Daunorubicin Hydrochloride
Study Locations (20)
Michigan
- Bronson Battle Creek - Battle Creek
- Spectrum Health Big Rapids Hospital - Big Rapids
- Cancer Research Consortium of West Michigan NCORP - Grand Rapids
- Mercy Health Saint Mary's - Grand Rapids
- Spectrum Health at Butterworth Campus - Grand Rapids
- Mercy Health Mercy Campus - Muskegon
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Brigham and Women's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Delaware
- Beebe Medical Center - Lewes
- Christiana Care Health System-Christiana Hospital - Newark
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
- NorthShore University HealthSystem-Evanston Hospital - Evanston
Maine
- Harold Alfond Center for Cancer Care - Augusta
- Eastern Maine Medical Center - Bangor
Maryland
- University of Maryland/Greenebaum Cancer Center - Baltimore
- Christiana Care - Union Hospital - Elkton
Florida
- AdventHealth Orlando - Orlando
Indiana
- Fort Wayne Medical Oncology and Hematology Inc-Parkview - Fort Wayne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2011-04-01 |
| Est. Completion | 2021-04-15 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01253070
The ClinicalTrials.gov registry entry for NCT01253070 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 70-participant average among 10 other Therapy-Related Acute Myeloid Leukemia trials with a reported enrollment target (23% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Therapy-Related Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Bone Marrow Aspiration is the first listed.
NCT01253070 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Michigan, Massachusetts, Delaware.
Frequently Asked Questions
What is clinical trial NCT01253070 about?
NCT01253070 is a clinical study titled "Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia". This phase II trial studies how well sorafenib tosylate and chemotherapy work in treating older patients with acute myeloid leukemia (AML). Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as daunorubicin ...
What is the current status of trial NCT01253070?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2011-04-01. Estimated completion is 2021-04-15.
What conditions does trial NCT01253070 study?
This clinical trial studies the following conditions: Therapy-Related Acute Myeloid Leukemia, Acute Promyelocytic Leukemia With PML-RARA, Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, FLT3 Gene Mutation.
What interventions are being tested in trial NCT01253070?
The interventions under investigation include: Bone Marrow Aspiration (PROCEDURE), Biopsy (PROCEDURE), Laboratory Biomarker Analysis (OTHER), Cytarabine (DRUG), Daunorubicin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01253070?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01253070 being conducted?
This trial has 20 study locations across Delaware, Florida, Illinois, Indiana, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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