Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03513484 · ClinicalTrials.gov registry record · Phase 1
Nintedanib and Azacitidine in Treating Participants With HOX Gene Overexpression Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Adult Acute Myeloid Leukemia, sponsored by Northwestern University.
- Active
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT03513484 is a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Adult Acute Myeloid Leukemia that is active but no longer recruiting, run by Northwestern University. The registered enrollment target is 44 participants, roughly in line with the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT03513484, a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Adult Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by Northwestern University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to find the appropriate dose of the study drug nintedanib when combined with azacitidine and the associated side effects of the combination in older adults with AML characterized by HOX gene overexpression who are not interested in or not considered fit for standard intensive chemotherapy. The use of the study drug nintedanib in this study is investigational. Investigational means that this medication has not yet been approved by the FDA to treat this type of cancer. Azacitidine received FDA Approval in 2004 for myelodysplastic syndrome (a blood cancer related to AML) and has a National Comprehensive Cancer Network (NCCN) guideline recommendation for treatment of older adults who are not candidates for or decline intensive remission induction therapy. We expect participation to continue in this study based on each participant's response to the drug, and ability to tolerate treatment. Participants may continue to receive study treatments for 6 cycles (one cycle is 28 days long). If the 6 cycles of treatment is completed, participants may be moved on to a maintenance phase of treatment. Treatment will continue until the participant's leukemia gets worse, or they experience serious side effects, have a break in treatment for more than 56 days or the study doctor feels it is best for study treatments to stop.
Conditions Studied
Interventions
- DRUG Azacitidine
- OTHER Laboratory Biomarker Analysis
- DRUG Nintedanib
Study Locations (1)
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2018-11-14 |
| Est. Completion | 2027-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03513484
The ClinicalTrials.gov registry entry for NCT03513484 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Azacitidine is the first listed.
NCT03513484 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT03513484 about?
NCT03513484 is a clinical study titled "Nintedanib and Azacitidine in Treating Participants With HOX Gene Overexpression Relapsed or Refractory Acute Myeloid Leukemia". The purpose of this study is to find the appropriate dose of the study drug nintedanib when combined with azacitidine and the associated side effects of the combination in older adults with AML characterized by HOX gene overexpression who are not interested in or not considered fit for standard inte...
What is the current status of trial NCT03513484?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2018-11-14. Estimated completion is 2027-01.
What conditions does trial NCT03513484 study?
This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Recurrent Adult Acute Myeloid Leukemia, Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A, Fibroblast Growth Factor Basic Form Measurement, FLT3 Internal Tandem Duplication.
What interventions are being tested in trial NCT03513484?
The interventions under investigation include: Azacitidine (DRUG), Laboratory Biomarker Analysis (OTHER), Nintedanib (DRUG).
Who is sponsoring clinical trial NCT03513484?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03513484 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Refractory 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.
-
A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia
RECRUITING · Phase 1
-
Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia
RECRUITING · Phase 1
-
Ruxolitinib in Combination With Venetoclax With and Without Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
RECRUITING · Phase 1
-
Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome
RECRUITING · Phase 1
-
Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
RECRUITING · Phase 1
-
8-Chloroadenosine in Combination With Venetoclax for the Treatment of Patients With Relapsed/Refractory Acute Myeloid Leukemia
RECRUITING · Phase 1
Explore more on PlainTrial
Refractory Acute Myeloid Leukemia
All registered trials for this condition
Recurrent Adult Acute Myeloid Leukemia
All registered trials for this condition
Illinois
All trials with a study site in Illinois
Recruiting now
Find trials open to new participants near you
Rankings
Top sponsors, conditions, and phases
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.