Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study of Therapy-Related Acute Myeloid Leukemia and Acute Promyelocytic Leukemia With PML-RARA, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage of patients who were alive at 1 year. The analysis was split between patients with having a FLT3 (FMS-like tyrosine kinase-3) ITD (internal tandem duplication) or TKD (tyrosine kinase domain) mutation. The FLT3 mutation testing at baseline was performed centrally for all patients.
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 |
What the finished NCT01253070 record still lists
NCT01253070 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 70-participant average among 10 other Therapy-Related Acute Myeloid Leukemia trials with a reported enrollment target (23% lower).
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 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
Similar trials for Therapy-Related 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 NCT01253070's enrollment target sits among peer trials
54 5th of 10 higher than 5 of 10 other Therapy-Related Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Therapy-Related 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Venetoclax and Azacitidine for the Treatment of Acute Myeloid Leukemia in the Post-Transplant Setting
ACTIVE NOT RECRUITING · Phase 2
-
AZA + Venetoclax as Maintenance Therapy in Patients With AML in Remission
ACTIVE NOT RECRUITING · Phase 2
-
CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old
ACTIVE NOT RECRUITING · Phase 2
-
Nivolumab and Azacitidine With or Without Ipilimumab in Treating Patients With Refractory/Relapsed or Newly Diagnosed Acute Myeloid Leukemia
COMPLETED · Phase 2
-
Decitabine With or Without Bortezomib in Treating Older Patients With Acute Myeloid Leukemia
COMPLETED · Phase 2
-
Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01269853 · 54 participants · Phase 1
Repeated Super-selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Relapsed GBM and AA
- NCT02390752 · 54 participants · Phase 1
Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...
- NCT02991248 · 54 participants · NA
Improve Dynamic Lateral Balance of Humans With SCI
- NCT02993900 · 54 participants · NA
Image-Guided Gynecologic Brachytherapy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI