Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01883362 · ClinicalTrials.gov registry record · Phase 2
Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML
A Phase 2 study of Acute Myeloid Leukemia, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 19
- Study locations
NCT01883362: Completed Phase 2 study of Acute Myeloid Leukemia, sponsored by Novartis Pharmaceuticals.
NCT01883362 is a Phase 2 study of Acute Myeloid Leukemia that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 60 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (48% lower). The trial reports 19 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01883362, a Phase 2 study of Acute Myeloid Leukemia, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 19
- Study locations
Study Summary
To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem cell transplant,
Primary Outcome
Relapse-free survival assesses the clinical benefit of remaining in remission free from relapse or death due to the disease. It was defined as the time from transplant to relapse or death due to the disease. Relapse following complete response was defined as reappearance of leukemic blasts in the peripheral blood or finding more than 5% blasts in the bone marrow.
Conditions Studied
Interventions
- OTHER Standard of Care
- DRUG Midostaurin
Study Locations (19)
California
- University of California San Diego Moores Cancer Center - La Jolla
- University of California at Los Angeles Oncology - Los Angeles
Tennessee
- Tennessee Oncology Sarah Cannon Research Inst. - Nashville
- Vanderbilt Univeristy Oncology - Nashville
Texas
- Baylor Health Care System/Sammons Cancer Center Oncology - Dallas
- Texas Transplant Physicians Group Oncology 2 - San Antonio
Colorado
- SCRI- Colorado Blood Cancer Institute - Denver
Florida
- H Lee Moffitt Cancer Center and Research Institute Oncology - Tampa
Georgia
- Northside Hospital - Atlanta
Illinois
- University of Chicago Medical Center - Chicago
Michigan
- Karmanos Cancer Institute Karmanos - Wayne State - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2014-02-06 |
| Est. Completion | 2018-04-30 |
| Phase | Phase 2 |
What the finished NCT01883362 record still lists
NCT01883362 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.
NCT01883362 lists 19 locations in 16 states (California, Tennessee, Texas).
Frequently Asked Questions
What is clinical trial NCT01883362 about?
NCT01883362 is a clinical study titled "Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML". To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem cell transplant,
What is the current status of trial NCT01883362?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2014-02-06. Estimated completion is 2018-04-30.
What conditions does trial NCT01883362 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT01883362?
The interventions under investigation include: Standard of Care (OTHER), Midostaurin (DRUG).
Who is sponsoring clinical trial NCT01883362?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01883362 being conducted?
This trial has 19 study locations across California, Colorado, Florida, Georgia, Illinois. 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 NCT01883362's enrollment target sits among peer trials
60 120th of 306 higher than 180 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure
RECRUITING · Phase 2
-
Venetoclax + Azacitidine vs. Induction Chemotherapy in AML
RECRUITING · Phase 2
-
A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)
RECRUITING · Phase 2
-
Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission
RECRUITING · Phase 2
-
A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
RECRUITING · Phase 2
-
Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Patients With Previously Untreated Acute Myeloid Leukemia
RECRUITING · 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
- NCT00576069 · 60 participants
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- NCT01297400 · 60 participants · Phase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
- NCT01734122 · 60 participants
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
- NCT01804634 · 60 participants · Phase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
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